The Big Red Biotech Blog

Another Way to Block Uptake with Biosimilars

You have to admit the innovators are doing a good job for their investors by pursuing every avenue at their disposal to block the quick introduction of biosimilars.  You have arguments for clinical trials, you have arguments against the FDA accessing info in BLAs (see Abbott) and now you have naming conventions.

What’s In A Name? A New Fight Over Biosimilars // Pharmalot.

The PhRMA and BIO trade groups are petitioning the FDA to require each biosimilar to have a unique non-proprietary name, purportedly to aid in pharmacovigilance. These groups say they want to be able to distinguish between the original drug and the biosimilar to insure patient safety.  But they really appear to want to put another hurdle in place that would prevent direct substitution or interchangeability - which of course should slow uptake of the biosimilar.

The GPA disagrees of course.  It wants biosimilars to follow existing drug-naming convention which is used globally. It further notes that the same international non-proprietary name (INN) has been given to biosimilars in other countries and regions. They note that medical knowledge of biologics and safety information is associated with the INN and a unique name woudl cause decoupling -- and ironically potentially hurt patient safety. Plus, they note.  There have not been a raft of safety issues with biosimilars in other geographies outside the US.

This debate boils down to money.  And clearly, from a policy standpoint, if biosimilars are delayed in their introduction in the US, much of the cost savigs that patients (and the healthcare system) might derive will be blunted.  Undoubtedly, successful launch of biosimilars will decrease prices for biologics (by how much?), but it should also increase uptake (volume) of these traditionally very expensive medicines in many parts of the world.  The net effect remains to be seen...........

Posted by Bruce Lehr Jul 13th 2012.

 

Foreign Inventors are Prominent Names on New Patents

The is post just in from Patent Docs blog.  It discusses a recent study don by the Partnership for a New American Economy (we're all for that aren't we?), a bipartisan group of US mayors and business leaders. The group advocates sensible US immigration reform (an oxymoron if ever I've heard one).  The grou released a report called "Patent Pending: How Immigrants are Reinventing the American Economy".

Highlights from the report include some statistics on US inventorship.  The study looked at invention filings in STEM (science, technology, engineering and math) fields at the Top 10 Universities filing such patents in the US (see blog post above for list and numbers of inventions).  Key tidbits:

• 76% of patents issued in 2011 at the "Top 10" schools named a foreign born inventor
• 54% of all patents issued to these schools named a foreign born inventor likely to face visa hurdles
• 79% of patents relating to pharmaceuticals had a foreign born inventor
• In STEM fields, 99% of patents had a foreign born inventor
• Every graduate with a STEM degree creates on average 2.62 additional jobs in US
• S. Korea, Switzerland, Spain, Italy, Germany and the UK admit 60-80% of immigrants on an economic need basis ---- the US? [drumroll please] ONLY 7%

Several reforms were recommended to make it easier for STEM students/graduates to get visas, particularly if they have investors for their ideas. See blog for more detail.  As one concession though, none of the immigrants will be allowed to visit or settle in Arizona.  Their economy is apparently fine.

Note: One of the commenters on the blog made the following point though by stating, "This is a classic lack of control problem. The unreported figure is what percentage of US patents have at least one native inventor? The answer is probably something like 95%. Publishing the control would show how meaningless this "study" is."  I do think the requested control stat is important to assessing the importance or not of the results.  As I have not read the original report, maybe it's in there.

Posted by Bruce Lehr Jul 5th 2012.

 

USPTO: India Was Wrong with Nexavar License

The Deputy Director of the US Patent and Trademark Office (USPTO) said that India was wrong to issue a compulsory license for Nexavar 3 months ago, and that the USPTO remains committed to opposing countries from issuing such licenses.

USPTO: Indian Compulsory License Was Wrong // Pharmalot.

Deputy Director Teresa Rea in testimony before the US House said that India's goverment issuance of the license did not meet international standards. She further asserted that drug companies will not market their products in countries like India or China if they persist in issuing licenses.  In particular, she noted the Indian public would suffer as they will not get access to these new drugs.

"We're consistent in our efforts to stop countries from further granting these licenses," she said.

These comments will undoubtedly add fuel to the debate over the negative effects that these licenses will have on drug company innovation and they're willingness to provide access to agressive compulsory license favorable countries, versus the negative effects of high priced drug and affordability/access to patient populatins in many of these same countries. There is not a clear cut answer.  The USPTO is accused of being too biased on both sides of the argument by the other side's advocates.

Posted by Bruce Lehr Jul 2nd 2012.

Supreme Court Ruling Generally Provides Clarity for Biosimilars

Lost in all the initial misreporting of the Supreme Court decision and even in the correct subsequent reporting was the positive impact the ruling had for Pharma and Biotech companies pursuing biosimilars. There had been fear that if the Court had struck down mandatory purchase of insurance provision portions of the law that the whole house would come tumbling down.  And with the fall of the Patient Protection and Affordable Care Act (PPACA) law, the the Biologics Price Competition and Innovation Act (BPCIA) would go too!

Fortunately for the biotech industry, that did not happen.  We still have a pathway in place to get to biosimilars filed and hopefully someday approved in the US.  Biologic drugs totaled $112.93 billion in worldwide sales in 2011, which constituted a $5 billion, or 4.6 percent, increase over 2010 sales.  Europe, in particular, has had a biosimilar pathway in place for nine years (since 2003), and has approved at least fourteen biosimilar products so far. The US needs to get it in gear.

The European biosimilars market generated is expected to reach almost $4 billion by 2017. Despite these profit incentives, and despite the framework being in force for over two years already, no biosimilars have been approved in the U.S., and most indications are that none are close (as of February, the FDA had yet to receive its first ABLA application).  BIO has been advocating that the new biosims that will compete with branded products should be put through a rigorous clinical trial program, avoiding the onslaught of cheap copycats that has blighted traditional small molecule treatments

The Supreme Court decision erases any hesitation biosimilar producers may have had in using the BPCIA due to the uncertainty of its survival.  Biosimilar producers can now move forward full steam with their biosimilar products without fear of legislative overhaul and potential disruption of their FDA approval progress. Pioneer biosimilar producers such as Sandoz and Hospira are already in Phase III human testing, and they have relied on the BPCIA to provide some clarity as to how biosimilars will be regulated in the U.S. Some of the biggest companies, like Merck, Amgen and BiogenIdec, have also set up biosimilar initiatives too.

The survival of the BPCIA is welcome news for biologics patient consumers as well, who hope to see lower prices in the near future on these important and typically costly drugs.  See Patent Docs blog, In the Pipeline, and Fierce Biotech.

Posted by Bruce Lehr Jun 30th 2012.

Indian Drugmakers Need to Bolster GMP Compliance

Both CARE Research and ICRA (India) credit agencies report that more stringent enforcement of GMPs by the FDA represents a significant risk to the revenue growth of Indian pharma companies -- if they do not raise their game. 

Tighter GMPs a significant risk for Indian drugmakers; CARE.

Companies like Ranbaxy and Aurobindo have had quality and compliance issues that are stunting their current revenue growth.  Closing of manufacturing units, delisting products and other woes have stricken these companies.

Indian companies are taking notice and responding by investing more in quality. This may be a short term increase in their costs and decrease in profits, but in the long run will make it easier for them to compete in more regulated Western markets.

The increase in FDA scrutiny is of course also happening in the US and elsewhere, and the India response of more investment in quality is just what the agency wants to see.  Companies that invest in quality will only become more competitive in the future.

Posted by Bruce Lehr Jun 25th 2012.

Capital and Tax Policies Burden Biotech Says Industry Leaders

This reports on a recent survey conducted by BIO of 170 biotech "industry leaders" and another 800 of our fellow citizens who are registered voters concerning the state of the biotech industry and some attitudes toward it.

PharmTech Talk » LIVE from BIO 2012: Capital and Tax Policies Burden Biotech, but Optimism Remains.

When the survey was conducted 5 years ago, 79% of industry leaders said they were "optimistic" about biotech's prospects.  This year that figure dropped to 63% in the optimists club. Key challenges (obstacles) cited for the industry were regulatory burdens and lack of capital.  Tax concerns were also cited.  I tend to be more dismissive of the first two complaints for companies with good projects -- but I do from time to time advocate here for more (continued) government tax credits and grants for the industry. 

The voter side of things was a bit scary to me. Apparently, 56% of voters favor enactment of US tax policies and direct funds that would help biotech businesses. It turns out though, when voters are actually educated as to what the biotech industry does, the number rockets up to 83%. Yikes!

Posted by Bruce Lehr Jun 22nd 2012.

China Changes Patent Laws To Get Cheap Drugs

Oh-oh! China's new IP law allowing compulsory licensing of drugs under patent came into effect as of May 1, 2012. The revised law is called the Measures for the Compulsory Licensing for Patent Implementation and is expected to open the doors for low-cost generic versions of patented drugs. The law also allows export of these drugs to other countries.

China Changes Patent Laws To Get Cheap Drugs // Pharmalot.

China announced this move in a seminar last month.  It seems to confirm that China's intent is to become a generic producer for the domestic and international market. Now we have both China and India issuing compulsory licenses.

Global drugmakers need to take heed as China already has many companies producing active ingredients for domestic and global suppliers. They can make generics and apparently will. With both India and China moving toward making more generic copies of patented drugs, this can't do anything but put more pressure on Big Pharma revenues. It looks like the pharmerging markets won't necessarily offer virgin territory to be mined by Western companies looking to gain compensory sales to make up for lagging sales in the West.

Posted by Bruce Lehr June 8th 2012

 

Indian minister rails against anti-generics smear campaign

The Indian government says multinational companies are running "a concerted campaign" against its generics industry!

Indian minister rails against anti-generics smear campaign.

"A concerted campaign against Indian pharma industry has been launched by MNC's whose interests are getting adversely impacted due to increasing global presence of Indian pharma companies", said Shri Anand Sharma, Indian Minister of of Industry and Commerce.

India is now billing itself as the "Pharmacy for the World" in response.  A central theme in this campaign is to show generic drugs produced in India meet the quality standards of drugs produced in Western countries or by Western competitors.

India is not going to take it anymore.

 

 Posted by Bruce Lehr May 9th 2012.

Biosimilars Not Only Threat Facing Biopharma

As this piece from BioProcess Blog points out, biosimilar competition is only one hazard faced by biopharma producers of the world's top bio drugs. In addition to increased price competition, there are the unscrupulous drug counterfeiters (see recent Avastin issues).  There is also the possibility of compulsory licenses being invoked in places like India (see recent Nexavar case). 

Biosimilar Competition is Only One of Several Threats Facing Biopharma Blockbuster Drugs.

These type of developments led PhRMA President and CEO John Castellani recently to comment, "If countries begin to routinely use complusory licenses, we could see a 'race to the bottom' in which governments in the developing world walk awayfrom their responsibility to support research and innovation in public health. In the absence of investment made by our members, and the resulting research and development, there would be no generic medicines for the world's patients."

As we say in Oz, "Biosimilars, Counterfeits and Compulsory Licenses, Oh My!"

 

Posted by Bruce Lehr May 8th 2012.

Bayer Challenges Compulsory License In India

To no one's surprise Bayer has gone back to court to challenge the India Patents Office decision to award a compulsory license to the generic manufacturer Natco to make Bayer's patented anti cancer drug Nexavar.  The IPO invoked compulsory license rules citing Bayer's high selling price ($5500 per patient/month) as preventing most India patients from using the drug. Natco will sell its version for $175 or a 97% decrease.

Bayer Challenges Compulsory License In India // Pharmalot.

“We will rigorously continue to defend our intellectual property rights which are a prerequisite for bringing innovative medicines to patients,” a Bayer spokesman writes us. “The challenges faced by the Indian healthcare system have little or nothing to do with patents on pharmaceutical products as all products on India’s essential drug list are not patented.  Rather, the order of the Patent Controller of India damages the international patent system and endangers pharmaceutical research."

“This is the trivial argument Big Pharma has been making for years to cover the impact of its monopoly pricing policies,” writes Brook Baker, a professor in the Program on Human Rights and the Global Economy at the Northeastern University School of Law, and a member of Health Gap, Global Access Project. “Of course, there are other barriers to access, but does Bayer want to seriously argue that medicine priced 60 times more than the newly announced Cipla price doesn’t adversely impact access?"

Bayer unmoved, appears ready for an all out legal fight, you could say "they are going to the Madras" on this one.

 

Posted by Bruce Lehr May 7th 2012

India to Invest cGMP Compliance for Vaccines

Four years ago, Indian regulators suspended licenses on 3 vaccine manufacturing facilities due to quality issues.  The suspensions resulted in vaccine shortages to great hue and outcry by the populace.  The government will now invest $37 M in plant upgrades to cGMP.

India plans $37m investment in vaccine cGMP compliance.

The DPT vaccine facility in Coonoor and BCG vaccine facility in Chennai will receive the bulk of the new investment.  Upgrades are nearly complete now at the third facility in Kasauli.  The government wants to see the improvement in quality and to boost vaccine output. 

HLL, a company best known for producing condoms, is responsible for making the upgrades.  Now, that's what I call real prophylaxis.

Posted by Bruce Lehr May 2nd 2012.

Berwick: Cost Effectiveness is Permanent Condition

Here is an Xconomy post from yesterday that highlights remarks made by Dr. Donald Berwick, the former administrator of the Center for Medicare and Medicaid Services.  He spoke last week in California at an invitation-only conference of healthcare executives and investors sponsored by the private equity firm Health Evolution Partners. He spoke about our health care system and health care reform. 

Dr. Berwick said that it would be a tragedy for America should the Supreme Court strike down the Obama Administration’s Affordable Care Act. Yet his primary theme was that it was getting very late in the game to slow the aggregate cost of health care as the baby boomers come into retirement. Citing his recent article in JAMA, Berwick noted that the sum of the lowest available estimates indicate that in excess of 20 percent of total health care expenditures is wasted. Berwick suspects we are really wasting one of every three dollars that we spend. This seems consistent with the oft-cited disparity between total US health care spending and outcomes in this country. 

The urgency of cost control is now such that, he said, there will be big reductions. The only question is whether we will do it in a good way or a bad way.  As to the future impact of all this on innovative life sciences companies, Berwick sounded an unmistakable warning. “If your products are expensive, it will be challenging; if yours is a firm focused on controlling costs, then your time has come.” In other words, biotech and medical device companies had better develop their case for cost effectiveness as their products enter into clinical development, because mere efficacy and safety may not get you paid in this brave new world.

What do you think his position would be relative to Abbott's strategy below to challenge the validity of biosimilars?

Posted by Bruce Lehr May 1st 2012.

 

 

BIO Voices its Comments on Biosimilars to FDA

BIO's response to proposed FDA guidelines is covered nicely in the Patent Docs blog. 

BIO asks FDA to publish specific statistics and/or ranges acceptable  for a determination of biosimilarity following the European model. BIO advocates for a more extensive clinical trial requirement to establish biosimilarity, including animal toxicity and human clinical trials. BIO also suggests a "cautious approach" to the extrapolation of data to other indications and patient populations without trials. BIO also asks for prominent labeling of the biosimilar to highight differences in route of adminsitration, presentations and conditions of use (presumably will inhibit switching) between biosimilar and reference product.

BIO also had comments related to quality and access to confidential information. On the quality front, BIO aks that any intentional differences from the biosimilar in host cell type, primary structure, formulation, or immediate package from the reference product result in immediate need to follow the BLA pathway and not ABLA.  BIO cites patient safety as the reason for this standard.

BIO requested explicit acknowledgement from the FDA that certain information within the reference BLA, including manufacturing facilities, be treated as confidential (see Abbott response to FDA in earlier blog post).  BIO disfavors comparison of a biosimilar to a non-US licensed product but wants to be particularly protective of manufacturing information in this instance. Trade secrets from all BLA must be protected from disclosure in biosimilar application process. The ABLA must stand on its own merit, supplemented with only public information.

In general, BIO suggests changes that will make it more difficult to gain ABLA (abbreviated biosimilar) approval.  These would appear to enhance patient safety and to also protect the competitive advantage of its BLA holder members.

Posted by Bruce Lehr Apr 26th 2012

Amgen warns biosimilar draft a threat to production innovation

The FDA is currently soliciting feedback to its recently published biosimilar guidelines.  Understandably, many among innovator pharma have comments to provide.  In its recent comments, Amgen asks the FDA if manufacturers are going to have to "maintain biosimilarity after approval."  If so, Amgen warns this requirement over time would stifle upgrades in manufacturing and quality improvements -- which would be bad for patients and a burden to the industry.  This could apply equally to innovators and biogenerics producers post-approval.

Amgen warns biosimilar draft a threat to production innovation.

Amgen suggests that a biosimilar applicant make its comparisons to the innovator product during a limited period of time and then establish a reference standard. Amgen then wants the FDA to treat the innovator product and the biosimilar as separae drugs from that point forward. Then each can make changes to their manufacturing or quality based on the mertis of their own data.

Industry commentators note however this would have implications on interchangeability -- likely the above approach would prevent these products from ever being considered interchangeable. Of course, Big Pharma and BIO have their reasons for not wanting to see interchangeability adopted anytime soon.

Posted by Bruce Lehr Apr 25th 2012.

 

 

 

 

Faster FDA Go Faster to Approve New Drugs

Pharmalot reports on the latest new bill introduced in Congress aimed at speeding the FDA approval process.  This one -- called Advancing Breakthrough Therapies for Patients Act --will ask the agency to speed the approval of "breakthrough drugs". 

Yet Another Bill To Speed FDA Drug Approvals // Pharmalot.

What's a breakthrough drug?  One aimed at a serious or life-threatening illness that has demonstrated preliminary clinical efficacy that suggests a substantial improvment over currently available treatments. The bill would let sponsors apply for breakthrough status and the FDA would need to rule Yea or Nay in 60 days.

The drug sponsor could still also apply for fast-track designations, accelerated approval or priority review status as well.  Now we have ABTPA, FAST and TREAT all sitting before various parts of the legislature looking to speed drug approvals in the FDA.  And, as PDUFA legislation needs to be renewed (lest the FDA run out of its user fee funding), Congress watchers think that at least parts of any or all of these Bills may have a chance to be added to the new PDUFA reauthorization proceedings.

Charge!

Posted by Bruce Lehr Mar 27th 2012.

Supremes' Prometheus Ruling: Death Sentence for Personalized Medicine?

There's no doubt where the writer of the IN VIVO blog stand on the wisdom of the Supreme Court's ruling against the Prometheus' patent.  The logical extension of the ruling (according to the writer) would be the denial of patent rights to a myriad (get it) of personalized diagnostic tests. 

The IN VIVO Blog: Supremes' Prometheus Ruling Has Dire Consequences for Personalized Medicine.

Not only would the analysis of small differences in gene sequences (as embodied by the Myriad case) potentially be covered by this ruling, but any tests that attempt to figure out why certain individuals respond better to one drug over another and how much drug should be administered should be covered. At least, if the logic exhibited in Prometheus were extended to other cases.

But then again, who ever accused the Supreme Court or most of the legal system to actually be bound by logic? Until another case comes along that will allow a reversal, I guess we're left with hanging chad in the biotech industry.

Posted by Bruce Lehr Mar 26th 2012.

 

Roche Cuts Prices on Two Cancer Drugs in India

The WSJ reports that Roche has decided to rebrand two of its popular cancer drugs for the Indian market and to reduce their prices significantly.  Herceptin and Mabthera will thus be renamed and repriced in that market. The drugs will be packaged locally by India's Emcure Pharmaceuticals, the countries 10th largest pharma.

Roche hopes that rebranding will cut down the practice of having middle men buy cancer drugs in low price markets and reselling (illegally) them into higher price markets.  It hopefully will also allow Roche to maintain its higher prices in markets outside of India.  It may also help stave off competition from generics.

This may also be seen as a response to India's compulsory licensing laws that allow (compel) the government to allow generic producers to obtain a license to patented drugs if they are too expensive for the domestic market and therefore unavailable to those patients who need them.  This controversial practice was used recently to grant Natco a compulsory license to make Bayer's Nexavar in India. See post. Roche appears to be trying to avoid a similar fate.

In an effort to work and play well with Indian authorities, Roche has cut its prices and also allowed and Indian company to do its final packaging. It has done its best to protect future revenue flow in India without a compulsory license being granted, and tried to protect its brand and pricing outside of India through rebranding. This is the logical proactive approach at deal-making that I expected drug companies to take after the Bayer license was compelled.

Posted by Bruce Lehr Mar 22nd 2012.

Big Pharma Blocks Accelerated Approval Pathway?

Earlier this week, I made a post based on an Xconomy article covering the FAST and TREAT bills in the congress presently aimed at speeding up the drug approval process. In a nutshell, these bills would create a pathway for drugs for to be approved more quickly (after small phase II studies) for serious conditions without better treatment options.  It is essentially taking the idea of the AIDs drug approval model and applying it more widely.  Companies would have to do serious post-market follow up as well and drugs could be pulled from the market if they didn't live up to their pre-approval billing.

Now BIO has come out for the bills, but PhRMA has NOT.  Some observers and analysts are viewing this very cynically with regard to Big Pharma behaviour and are essentially accusing them of scuttling the bill for their own purposes.  Namely? Big Pharma wants to keep Biotechs as a novel drug producing farm system from which they can acquire new drugs, rather than give the Bio's the possible ability to launch drugs on their own. 

"Sen. Hagan's proposal would have been devastating to the big pharma R&D oligopoly," writes Roy. "If small biotech companies could get their drugs tentatively approved after inexpensive phase II studies, they would have far less need to partner those drugs with big pharma. They could keep the upside themselves and attract far more interest from investors. Big pharma, on the other hand, would be without its largest source for innovative new medicines: the small biotech farm team."

Pretty strong words and sounds a bit too true to just dismiss doesn't it?  Let's hope not.  I hope that Big Pharma can stand on its own two feet to develop its own products if it has to do so. If not, they should become investment bankers not drug developers. See Fierce Biotech and In the Pipeline.

Posted by Bruce Lehr Mar 16th 2012.

Biosimilars— Big Pharma Whistling Past Graveyards?

This from the PharmTech blog.  I want to focus on cooments by the first speaker in the post, Neil Mahoney, President & CEO of Global Pharma Alliance. His talk indicated that it would be much more difficult to produce a biosimilar than for a generic small molecule - which is clearly true -- but he also cited a cost of $100-$200 M to develop a follow on biologic.  Wow!

PharmTech Talk » Biosimilars—It’s the Differences That Really Matter.

I think that figure has to be looked at with skepticism and if true would only apply to a US market.  But we have a GLOBAL pharma industry now.  Estimates from Dr. Reddy's lab indicate that a western company could expect to spend $50-$100 M to develop a biosimilar (half the figure cited above) -- but also than an Indian company could expect to do this for only $10-$20 M.  Additionally, India can be expected to offer the products at 25-40% less.

Dr. Mahoney also trots out data that says the initial biosimilars lanched in Europe did not exactly take the market by storn in terms of share -- also true. But to suggest that this trend will hold up going forward is folly I think.  The first round of biosimilars were drugs like EPO which were not nearly as costly to use as the next round of mAbs to treat things like RA or cancer.  Given the current health crisis, and government austerity programs, I cannot doubt that there will be incentives in place to encourage development and approval of biosimilars throughout the world -- yes -- even in the US.  Moreover, as more of the mainline pharma companies like Pfizer, Merck, Novartis (Sandoz) etc start pushing biosimilars, I expect the adoption rates to increase and the price erosion to accelerate. 

While biosimilars will require more investment and skill than small molecule generics, I don't think that is insurmountable.  Economics and healthcare policy will drive their existence.  It is only a matter of time in miy mind and that time will be quicker than a lot of naysayers believe.  I think any thought to the contrary is wishful thinking and amounts to "whistling past the graveyard".

 

Posted by Bruce Lehr Mar 16th 2012.

Is it Safe to go FAST with Drug Approvals?

Xconomy's Luke Timmerman wrote a post today in his blog about the FAST (Faster Access to Specialized Treatments) legislation that is currently in the House. Advocates of FAST are pushing for more drugs to be approved sooner by FDA for serious diseases -- that is after they've been shown to be safe and likely with some sort of surrogate endpoint data pointing to their possible effectiveness. Proponents liken this to speedier approvals given to AIDs drugs during the early days of that crisis.

The conundrum for regulators of course is if they approve drugs more rapidly without as much efficacy data, there is a possibility that the drugs may not perform as advertised in real (and usually larger) patients populations (ala Avastin for breast cancer).  The quid quo pro for this type of program therefore has to be the industry's diligence in doing and reporting post-market follow up.  Less than sterling drugs could then have their approval revoked.

The post also quotes people like Alnylam's CEO, John Maraganore, as being an advocate as it may offer his company a way of getting drugs to market faster and at less expense in more abbreviated clinical trials. Maraganore argues this in turn woudl make investing in smaller and mid-sized biotech's more attractive -- due to lower costs and heightened regulatory predictability. 

An In the Pipeline piece this week, points out the problems the drug industry has had with it's productivity as fewer and fewr drugs are introduced at greater and greater expense -- a sort of reverse Moore's law or Eroom's Law as th epost explains.

In addition to FAST in the House, the Senate has its version too, known as TREAT (Transforming the Regulatory Environment to Accelerate Access to Treatments). It looks like this idea's time may have come - and with desires to reduce health care costs, and boost the health of the US Biotech industry momentum is building to give this idea a try.

Posted by Bruce Lehr Mar 12th 2012.

GSK's Witty Fires Salvo at British Government Drug Policies

Among other things, GSK's CEO Andrew Witty says the British goverment is "systematically delaying" the introduction of new cancer drugs, making "false economies", not buying "the next round of innovation", treating drugs as a "simple procurement business" and in general lacking "any kind of strategic thoughtfulness."

Other than that, he thinks the Government is doing a great job in setting UK drug approval and reimbursement policy. He further implies if GSK keeps losing its abiilty to earn a better return that the UK ministers may face a choice between health budgets and drug industry employment. See PharmaGossip and Pharmalot blogs.

Posted by Bruce Lehr Feb 27th 2012.

Biosimilars are Progressing by the 'Totality of Evidence'

Two more blogs weigh in on the FDA guidelines published for the Biosimilar approval route last Thursday.  The Patent Doc blog seems a bit underwhelmed by the lack of specificity of the guidelines but acknowledges the FDA had a relatively short time line to issue their guidance.  It does acknowledge the guidelines will likely evolve in practice and the FDA gave itself maximum flexibility in interpreting them. The FDA will use a "totality of evidence" standard similar to that adopted in Europe.

The BioProcess Blog for its part seems a little more upbeat that the FDA put guidelines out there to get the process rolling.  In general, it was positive about the fact the FDA will allow the possibility of formula changes and different delivery devices from biosimilar to the reference product without either being an automatic block to taking a biosimilar path. The blog authors were also happy that the FDA will accept data from non-US licensed products in considering the "totality of evidence" in support of a biosimilar application.

To date the FDA has received 31 requests for meetings to discuss company plans for their biosimilars, and 21 of those had been held by the end of December 2011.  There have also been 9 INDs for biosimilars filed to date and the agency is expecting a full 351(k) application soon.  The process is well underway and there is still 60 days for interested parties to comment and suggest changes to the Draft guidelines just issued.

Posted by Bruce Lehr Feb 15th 2012.

Is the US Facing a Pharmaceutical Manufacturing Gap?

Here's a post from PharmTech Talk discussing recent testimony by FDA's Margaret Hamburg before the House Committee on Energy and Commerce as it considered extending PDUFA (for the fifth time). 

Is the US Facing a Pharmaceutical Manufacturing Gap?.

Hamburg cited numbers to show that the FDA had approved more new druigs for launch first (70% of last year's 35 new drugs) than other agencies in the world.  In fact, 75% of the new drug approved in US and EMA between 2006 and 2010 hit the US first.

PharmTech noted that the US is the largest drug market at 36% of the world's total in 2010, while the top 5 EU markets accounted for another 17%, and the BRIC countries another 18%.  But the question arose, does the US manufacture enough given its market position and importance?  It turns out that 40% of the drugs consumed in the US are made outside the US, and 80% of the APIs used within are made ex-US. 

The writer questions should the US support its internal manufacturing of drugs more?  I would say, Yes, but with particular regard to supporting biomanufacturing.  A lot of the drugs and APIs cited above are small molecules that have moved to generic status and have therefore graduated to lower cost (at least currently) areas of manufacturing outside the US.  While it may be nice to retain some of that volume, I think it is more critical to keep the bio-drugs as a major focus in the US. 

I think US government policy should look for ways to continue to support biotechnology in both discovery and manufacturing to help maintain our leadership position. 

Posted by Bruce Lehr Feb 6th 2012.

 

FDA Gives Biosimilars Update

Rachel Sherman, Associate Director for Medical Policy, within CDER gave an update on biosimilars today. Protein biosimilars (but not chemically synthesized polypeptides) will be regulated under Public Health Services Act section 351. 

PharmTech Talk » FDA Gives Biosimilars Update.

The 351 (k) approval route will require the FDA to consider:

• Analytical studies to show th ebiosimilar is highly similar to the reference product
• animal studies (including toxicology) as needed
• clinical studies to establish safety, purity and potency in one or more conditions of use for the reference product

To assess biosimilarity, Sherman explained that each study adds a piece of information to understand what a biosimilar product is and is not, and what other information is needed. The FDA may also adopt the European approach to "use the totality of the evidence" to address biosimilarity.

To date, there have been 35 Pre-IND meeting requests for proposed biosimilars to 11 reference products, 21 Pre-IND meetings held and 9 INDs received at FDA. The line is rapidly forming.

FDA guidance has not appeared as yet, and is still in "final stages" at the agency.  No timeline for publication has been issued.

Posted by Bruce Lehr Feb 3rd 2012.

 

Study says Speedy FDA Approvals Associated with More Safety Questions

A recent study by Harvard and Stanford researchers seems to indicate that FDA approvals made closest to the review deadline have higher post-market safety problems.  While no cause and effect is yet claimed, the researchers do note a positive association and suggest the deadlines link to funding may have unintended safety consequences.

FDA Review Deadlines Caused Safety Issues: Study // Pharmalot.

PDUFA which links FDA funding to its ability to meet drug application review deadlines may be altering FDA review behavior.  The study indicates that more reviews now pile up around the 6 month deadline than before PDUFA existed as legislation. Drugs reviewed and approved less than 2 months before the deadline is reached experience higher post-market safety issues than drugs approved more than 3 months before the deadline or after the deadline was reached. A new black box warning is 3.27 times more likely for a drug approved within the 2 month window, and safety related withdrawl is 6.92 times more likely for these drugs.

The study was published at a time when Congress is conducting PDUFA hearings looking at renewal of the legislation. How are we going to choose to balance risk and reward?

 

 

Posted by Bruce Lehr Feb 2nd 2012