The Big Red Biotech Blog

Still More Senators Fight Over Biosimilars - Exclusivity Language

As the Pharmalot blog reports, another letter has graced the FDA Commissioner's desk from the Senate explaining the intent of the recent biosimilar legislation passed during healthcare reform.

Still More Senators Enter The Fight Over Biosimilars // Pharmalot.

This letter from Senators Tom Harkin, John McCain, Chuck Schummer and Sherrod Brown asserts that the biosimilar legislation is clear that the FDA can "begin reviewing biogeneric applications during the 12-yr exclusivity period".  They argue the intent of the law is to speed biosimilars to the market thereby saving patients thousands of dollars.  This group of Senators say "we strenuously object to any further efforts that would further block or delay generic competition at the expense of patients in need."

This is in marked contrast to the Senate letter written a couple weeks ago from Orrin Hatch, Kay Hagan, Michael Enzi and John Kerry that suggested there was a 12-year data exclusivity period in the legislation and that brand name manufacturers could earn up to another 12 years if their drugs were changed in a way that enhanced safety or effectiveness.

If I'm sitting in the FDA Commissioner's seat, the situation should be as clear as mud. Now, all the FDA has to do is formulate the policy to make everybody happy. A piece of cake. 
Posted by Bruce Lehr Jan 25th 2011.

EMA Committee Backs Novartis' Gilenya MS Pill

The WSJ reports that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended that oral MS drug, Gilenya, be approved for the treatment of patients with highly active relapsing-remitting multiple sclerosis.

The news should pave the way for EMA approval and give Novartis the chance to launch this purported blockbuster in 2011.  The EMA final announcement is expected in about 3 months.  An approval will give Novartis a further leg up on its competitor Merck KGaA's cladribine which failed to get market approval in Europe. Biogen Idec also failed (coincidentally) on Friday to gain EU approval for its oral MS drug, Fampyra.  Novartis will soon be able to go after its share of the $10 B MS market.

Novartis will present a strong challenge to the others MS drug players including Biogen, Bayer and Teva. Teva's Copaxone had $2.8 B in sales in 2009 and Biogen's Avonex added accounted for another $2 B.  Because Gilenya is a pill and not a daily injection, analysts believe Gilenya can vault to sales of $3.5 B or more.  Patient groups welcomed the news.  There are about a half-million MS patients in Europe.

 

 

Posted by Bruce Lehr Jan 23rd 2011.

 

Patients Petition FDA Over Genzyme Drug Shortage

Fabry patients in need of Genzyme's Fabrazyme are challenging again.  Last month, the challengers lost their attempt to get the NIH to exercise so-called march-in rights to allow another manufacturer to enter the market to make Fabrazyme - for which Genzyme hoolds the license to the patents.  This request was denied due to the NIH's feeling that no alternative manufacturer could start now and bring drug to market before Genzyme could get back into fuller production.

Patients Petition FDA Over Genzyme Drug Shortage // Pharmalot.

Now two of these patients are asking the FDA to regulate how Genzyme allots its drug.  It is asking the agency to make sure drug goes to the US market first before going to Europe -- apparently 62% of the drug is shipped overseas.  The EMEA has licensed an alternative drug, Replagal, made by Shire for the treatment of Fabry's.  The same drug is not licesned in the US and Shire as yet has not applied for one.

The US market is therefore short of Fabrazyme - where current patients subsist on a suboptimal dose in many cases and new patients can't get any drug - and has no access to Replagal.  There have been 3 reported deaths of Fabry's disease patients in the US due to the shortage.  No such deaths have been reported in Europe. Now the FDA is beginning to import Replagal to replace the Fabrazyme which was exported -- but patients must show "critical need" on a case by case basis to receive the US-unapproved drug.

Stay tuned for this one.

 

Posted by Bruce Lehr Jan 20th 2011.

Will the Vise Tighten on Pay-for-Delay Agreements?

This PharmaTech Talk post recaps the recent events with pay-for-delay deals. The FTC and DOJ are both on record as opposing these arrangments as anti-competitive.  Several pharmacies and wholesalers have legally challenged their validity in an antitrust suit, and now 31 AG's from around the US have filed an amicus brief asking the Supreme Court to review these arrangments - specifically in a case involving Bayer and the generic producers Barr Pharmaceuticals and Watson Pharmaceuticals.

PharmTech Talk » Will the Vise Tighten on Pay-for-Delay Agreements?.

Interestingly, the EU has also cracked down on what they term "patent settlements".  The European Commission is reviewing patent settlements from Big Pharma companies in 2009 - indicating that patent settlements are a concern because they may delay the market entry of cheaper generics.

According to the EU, its monitoring is beginning to pay off. It declared that only 10% f patent ssettlements in the period July 2008 to Dec 2009 were problematic as compared to 22% for the period Jan 2000 to June 2008.  See Reuters.

The Pharmalot blog adds some further interest to this topic. It notes that in relation to a pending pay-for-delay suit -- involving Cephalon and the generic drugmakers - Ranbaxy Labs, Mylan Labs and Teva Pharamceuticals over copycat versions of Provigil -- 3 dozen other drug makers are suing to prevent the FTC from disclosing the contents of their pay-for-delay deals in response to a Cephalon petition to force FTC disclosure.  Cephalon want the documents to challenge FTC conclusions that pay-for-delay deals are bad for consumers.  The other drugmakers apparently fear this disclosure despite what Cephalon may think.

We may get to see the Man Behind the Curtain in these pay for delay deals.

 

Posted by Bruce Lehr Jan 20th 2011.

Biologics 12-year Data Exclusivity and Congressional Intent

The Patent Doc blog notes that both the House of Representatives and the Senate have written letters to the FDA explaining their intent in inserting a 12 year period of data exclusivity for biologics in the recent healthcare reform act.

Perhaps amazingly, both legislative bodies agree!  The message to the FDA is that innovator drug makers were NOT granted market exclusivity for biologics.  They were granted data exclusivity - meaning a follow on manufacturer could not cite the original data filed with the FDA to support safety, purity and potency for the follow on until 12 years had passed.  However, nothing precludes the follow on manufacturer from submitting their own data.

With regard to so-called "evergreening", both letters remind the FDA that the Act does prohibit it from granting more than one period of data exclusivity to the innovator. 

The Act explicitly precludes any period of data exclusivity for the following:

o   A supplement to a BLA; or
o   A subsequent BLA (from the same company) for a non-structural change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength; or
o   A subsequent BLA (from the same company) for a structural change that does not result in a change in safety, purity or potency.

The letters from the House and the Senate close with a statement that "the Act provides incentives for innovators to research and develop new treatments for patients," including an innovator company that "modifies an approved product to produce a change in safety, purity or potency.  Approval of such a new drug will not change the data exclusivity for the "first-generation" product.  The new product will be entitled to its own 12-year data exclusivity period like all new biologic drug products.

After all this bluster and discussion, the Patent Doc blog notes that the FDA is not bound to follow any of the so-called intent expressed in either letter, nor is a Court bound to interpret the law based on the intent expressed in either letter. But at least there is consensus on something - even if it may be no more than a howling wind full of sound and fury, signifying nothing.

 

You can also read some more coverage on these letters published in today's WSJ Health.

Posted by Bruce Lehr Jan 12th 2011.

Longer Data Exclusivity Is A Good Deal For Who?

This is an interesting post from the very interesting Pharmalot blog.  It cites an analysis of the effects of extending the data exclusivity provisions in the Hatch-Waxman Act from 5 years to 12 years as was recently done in the new healthcare reform act for biologics. 

According to the analysis done by Health Affairs, extending data exclusivity to 12 years would increase the lifetime revenue of a drug by 5 percent, on average, leading to another 228 drug approvals over the next 50 years, relative to the number of approvals the authors project under the current Hatch-Waxman data exclusivity provisions. And this would lead to an increase of 1.7 months in average life expectancy for those turning 55 in 2060

Longer Data Exclusivity Is A Good Deal For Who? // Pharmalot.

Basically, the analysis concludes that consumers paying more now to support data exclusivity for a longer time span, will effectively subsidize benefits of consumers in the future who will get more new drugs and an extension of average lifespan (albeit only 1.7 months in 50 years!). Presumably, this effect will be due to the longer data exclusivity resulting in higher proifts and more incentives for drug producers to make more drugs (the 228 referenced above).

By Health Affairs calculations, a 55 year old in 2060 would receive an net benefit of $10,400 from the subsidy/drugs developed due to the largesse of previous generations.  Pharmalot asks is it worth it?

 

Posted by Bruce Lehr Jan 12th 2011.

New Drugs 2010 - Fewest FDA Approvals since 2007

Here's a piece republished in its entirety from Bloomberg. 

Twenty-one new drugs were approved in the U.S. this year, the fewest since 2007, as the Food and Drug Administration showed more willingness to delay or reject medicines with potential safety risks.

The tally, compiled by Bloomberg from an FDA database, compares with 25 approvals last year and 24 in 2008, according to the FDA’s website. Nineteen new drugs were cleared in 2007, the fewest in 24 years.

Today marks the last regular work day of 2010 for the U.S. government. This year, the FDA also restricted the use of London-based GlaxoSmithKline Plc’s diabetes pill Avandia and withdrew from the market the weight-loss drug Meridia made by Abbott Park, Illinois-based Abbott Laboratories. The agency citied heart complications in both actions.

“There’s a sense that the FDA is being more cautious,” said Les Funtleyder, a fund manager at Miller Tabak & Co. in New York, in a telephone interview. “If the rules get too onerous, it could potentially keep innovative drugs out of U.S. hands.”

My comments is that the drug makers and agency still need to work harder at collaboration during the drug development process and in defining data needed from clinical trials and designs needed to generate same.  The industry is struggling enough with a withering R&D pipeline. It really cannot afford to have drugs go down as frequently as has been the case in the past few years in phase III.  Also, there needs to be a reality check by industry to NOT put drugs into late stage clinicals that do not have a chance to better the results of products that are already out there.  In many cases, we simply need to be testing better drugs that are designed to deliver better benefits. 

 

 

 

Posted by Bruce Lehr December 31st 2010.

 

Cancer Drugs in Combination - A New Testing Trend?

This piece comes from Xconomy and notes that Merck and Sanofi are joining forces to test new cancer drugs in combination - a trend that appears to be gaining traction with other players in the oncology field as well.  Combination therapies are often used in cancer.  However, historically the combinations weren't tested together until each drug separately reached a fairly late stage (or was already approved).  Now we have companies developing philosophies to test drugs in combination at an early stage of clinical trials.  This is particularly popular in the treatment of cancer as frequently several signalling pathways that could affect the disease may be simultaneously attacked.

Previously, Merck and AZ have teamed up with their respective AKT  and MET inhibitors.  Now Merck and Sanofi plan to test their SAR245408 and SAR245409 inhibitors of the PI3K/mTOR pathway. Both partners will test each other's drug in combination with their own in Phase I trials.

The FDA issued draft guidelines designed to encourage companies to work in tandem to develop two or more new drugs to be used in combination to treat cancer and infectious diseases, among other illnesses. In addressing the new guidelines, FDA commissioner Margaret Hamburg said they are the result of a growing understanding that experimental therapies may need to be used together in order to be more effective or to prevent drug resistance.

Despite the excitement, efforts to study investigational drugs in combination are still in their infancy. Phase I is the first stage of clinical testing, so these new drug “cocktails” are still several years from reaching the market. Scientific, clinical, regulatory and intellectual property hurdles all must all be overcome if these novel combinations are to provide breakthrough cancer therapies for the patients who desperately need them.

 

 

Posted by Bruce Lehr December 30th 2010.

EMA Head Rips Pharma R&D Waste vs. Big Pharma Fears Increasing Regulatory Hurdles

Last week, departing EMA chief Thomas Lonngren took the opportunity to question Big Pharma's R&D spending - saying, in effect, that $60 B of $85 B spent annually was being wasted.  He reasoned that only 7-9 drugs were making it to market that were worth maybe $20 B and where did the rest of the $85 B in value go?  He also took Big Pharma to task in relation to which therapeutic areas it chose to pursue - sopecifically he criticized cutbacks in CNS therapies and in antibiotic research. He finished his mini-rant with conviction that drug regulators around the world would unite to cooperate more in the coming years, saying "The evolutionary momentum of this is unstoppable." See Fierce Biotech report.

Yesterday, I read this article in the WSJ regarding Big Pharma's (and its investors) fears of how regulatory scrutiny is rising in unpredictable ways -- from Big Pharma's viewpoint.  The poster child in this particular case was AstraZeneca's Brilinta receiving a delay in regulatory approval from the FDA - despite having already been approved by EMA earlier this month. AstraZeneca feels it can negotiate the regulatory hurdle but at what cost?  Investors reacted by causing a significant drop in AZ's share price - reflecting a possible worst case scenario that the drug will never be approved in the US.  Are drug developers and regulators working at odds here?

The fact is that success rates for new chemical compounds have fallen from about 12% a decade ago to less than 8% today and the trend is still going down. Clinical trials must be up to twice as large and costs of development are rising.  Is this anyway to run an industry? It is high time that both developers and regulators work on changing the model to better optimize use of precious R&D and regulatory resources to get more successful launches of needed drugs to the market. This would seem to be more productive than hand wringing by either side.

 

 

 

Posted by Bruce Lehr December 21st 2010.

 

Merry Christmas! Big Pharma Naughty Not Nice

Increasingly Big Pharma has been caught with its hand in the regulatory cookie jar resulting in a rapidly increasing set of criminal and civil penalties as chronicled below in this post from PharmaGossip.

http://pharmagossip.blogspot.com/2010/12/merry-christmas-big-pharma-naughty-not.html.

 

 
Posted by Bruce Lehr December 19th 2010.

 

EMA Does No Better than FDA with Clinical Trial Site Inspections

According to this analysis published in Outsourcing-Pharma.com, the EMA inspects fewer than 1% of clinical trial sites included in marketing authorization application (MAA) submissions that it is meant to regulate. Of course, this is resource related as claimed by almost every other regulatory agency in the world, including the FDA.  See here for post where GAO criticized FDA in November for poor implementation of foreign clinical trial inspections.

The Outsourcing Pharma post created an interactive map showing GCP inspections of a country’s trial sites as a percentage of its sites included in MAA submissions. The map can be filtered to show the percentage of inspections in any year from 2005 to 2009. Furthermore, clicking on a region in the graph below filters the map to show data from countries in that part of the world.

Posted by Bruce Lehr December 13th 2010.

Two Academics Challenge ACLU Claims in Gene Patent Case

Leave it to the Patent Docs blog to keep us updated on the AMP v USPTO (Myriad) case. In the latest installment, the amicus brief of two academic professors - Christopher Holman, Ph.D. Associate Professor of Law, University of Missouri, KC School of Law and Robert Cook-Deegan, research Professor and Director, Center for Public Genomics at Duke University - argues the wisdom of retaining patent eligibility status for human genes. The brief was not filed to specifically support either side - rather it was filed to support maintenance of "a sensible patent system that accomplishes the constitutional goal of promoting the Progress of Science and useful Arts."

Basically, the Professors point is the there should be no outright ban on gene patents.  Gene patents are useful in protecting an innovator and provide impetus for funding of genetic diagnostic testing, personalized medicine, and biotechnology in general (including biological drug development).  They argue that there are more targetted regulatory paths one could take that would be more appropriate, or application of other areasof patent law - short of a ban on gene patents - would also help.

They note that gene patents have been issued for more than 30 years without the widespread restrictions of access to the market.  In fact, patents have created incentive critical in attracting the substantial investment needed to fuel discovery and development for market introduction. Patent protection has been used to block direct competition among innovator companies, but there is scant evidence that this has had a negative impact on noncommercial, academic research.  They note that most concerns about negative consequences of gene patents are based on the assumption that patents are always enforced - which has proven not to be the case.

The authors also note that observers need to differentiate between restrictions stemming from gene patents - namely restrictions between competitive commercial labs and restrictions on patient access to the specific gene test in question.  For example, Myriad can use patents to restrict commercial competitors but there is little evidence that patients couldn't gain access to the tests or that fewer were tested as a result in the US. 

If you think Myriad's claims are too broad, maybe they are say the authors.  But don't invalidate gene patents to resolve.  Use less blunt force tools to achieve the same end.  Myriad's patents have been variously characterized by critics as:

• BRCA genes were "well known"
• Isolation of the genes was "inevitable"
• BRCA testing would be available without Myriad's contribution
• Myriad was not the first to identify BRCA

All of these are matters of substantive patent law and do not require an attack on patent eligibility. Proper claim construction is the appropriate tool for preventing the claims from being successfully asserted against activites outside their scope.

Moreover, if you don't like Myriad's business practices, then regulate them.  Basically, they argue the FDA and other regulators should wake up in the US (as their counterparts in Europe have on this issue), or lawmakers can step in.  For example, limitations can be placed on infringement liability for individuals using patented genetic technologies for research or genetic testing uses.  This would be analogous to similar restrictions that exist now for ssurgical procedures and other "medical activities". Other possibilities that could be tried include compulsory licensing, march in rights under Bayh-Dole, and practice by state affiliated institutions with sovereign immunity. All less drastic than a general gene patent ban.

I encourage you to read the entire summary argument, and if really motivated go find the brief in its entire glory.  Just remember, at present, gene patents are necessary to provide intellectual property protections to fuel investment - a position supported by BayBio, Genetic Alliance, and BIO.

 

Posted by Bruce Lehr December 8th 2010.

 

More on Biosimilar Approval Pathways

Chemical & Engineering News just published its take on the FDA's progress towards establishment of a biosimilars approval process. The publication writes, "Fights over testing requirements, data exclusivity, and even how to name these so-called biosimilars, or follow-on biologics, are delaying the agency from putting an approval process in place."

FDA now has to decide how much testing is necessary to show that a biosimilar is as safe and effective as the original product.  But there is much disagreement over exactly how much clinical testing FDA should require.  Because of the complexity of protein-based drugs, FDA is finding it difficult to strike the right balance between the desire for low-cost biologics and the need for careful evaluation of safety and efficacy.

On one side of the debate are the biotech companies and patient groups, which insist that the complexity of biological products makes animal toxicology studies and human clinical trials essential for establishing safety and efficacy.  They argue that, “A biosimilar product will invariably be made up of a different mixture of related molecules than the product it is attempting to copy. The challenge with biosimilars is knowing which structural variations matter clinically and which do not.”  Makes sense, huh?

On the other side of the debate are the generic drug manufacturers that claim that clinical testing for biosimilars is redundant and unethical because it has already been performed on the original products.  They argue that if biosimilars producers have confirmed that their product is “highly similar” to a reference biologic with state-of-the-art analytical tools, then that biosimilar “should be subject to clinical study requirements only to the same degree as is expected for originator products making manufacturing changes.” Such requirements typically do not involve clinical testing.  Makes sense, huh? 

FDA has begun the process of establishing a biosimilars approval pathway, but observers say it will likely be several years before the agency sorts through all the challenges related to implementing the new law.

So stay tuned, and read the whole article, entiled "Untangling Biosimilars".

 

Download Untangling Biosimilars

  

 

 

 

 

Posted by Bruce Lehr December 4th 2010.

 

Everything You Wanted to Know About EMA Guidelines for BioSimilar Antibodies but Were Afraid to Ask......

Today the Patent Doc blog provides some nice coverage on the EMA published guidelines for biosimilar monoclonal antibodies.  The guidelines will now be subjected to public comment until May 31, 2011.  The FDA will undoubtedly be watching with interest as it is currently tasked to come up with similar guidelines for the US following the healthcare reform legislation this past Spring.

The first installment of the guidelines is entitled, "Guidelines on similar biological medicinal products containing monoclonal antibodies" and covers non-clinical and clinical studies. 

The second set of guidelines addresses the problems with detection and risk related to the development of the mAb response - i.e. immunogenicity.

 

 

 

 

Posted by Bruce Lehr December 3rd 2011.

FDA Gets Mediocre Grade from Pharma Execs in PWC Poll

Pricewaterhouse Coopers life sciences team ran the 5th survey of pharmaceutical executives -- ceo, coo, a vp or director of regulatory affairs and quality -- representing 50 companies on their ratings of how they thought the FDA was doing. 

What Does Pharma Think Of The FDA? Not Much // Pharmalot.

The results are mixed at best. There seemed to be some agreement that the FDA has improved with its feedback on product development and driving that into companies development plans.  But, the agency wasn't seen to have improved much on its drug approval process and especially in the working relationship with pharma surrounding this process. Users fees were another area of mediocrity with criticism leveled at the agency for lack of transparency, excessive fees, lack of effectiveness in speeding review time, and only 24 percent the fees work as intended.

Bottom line: better luck next survey.

Posted by Bruce Lehr November 30th 2010.

Biosimilar Stampede to Commence soon in EU?

 

According to a story in Fierce Biotech, now that the EMA has published guidelines for how it plans to review biosimilar applications, we could be in for a stampede charge of applications by the largest biosimilar competitors like Novartis (Sandoz), Teva and Hospira.  With Roche's Rituxan, Herceptin and Avastin coming off patent, these top selling drugs look like inviting targets.  The Financial Times says that the first competitive products could be seen as early as 2012.

Merck KGaA (Erbitux), J&J (Remicade) and Abbott (Humira) could also face competition in the relative near term (though later than the Roche products). Roche for its part wants regulators to be cautious and slow.

"We believe that patient safety must be of the highest concern when evaluating the development, approval and marketing of biosimilar products"

 

 

Posted by Bruce Lehr November 30th 2010.

Genzyme Successfully Toeing FDA Line

According to this story in Boston.com, Genzyme has met all the milestones so far that the FDA has set for them in relation to its consent decree over failings at the Allston manufacturing facility.  Under the final terms of the consent decree announced in May, Genzyme agreed to stop the "filling and finishing" step at Allston for all of its drugs that are distributed in the United States.  The deadline for meeting this provision is the end of November 2010.

Genzyme transferred the fill & finish steps for Thyrogen (thyroid cancer) and Fabrazyme (Fabry's disease) from Allston to its plant in Ireland or outsourced to third parties. Allston still makes Cerezyme and Fabrazyme but not doing fill & finish work on them.  Allston can do fill & finish work on drugs NOT distributed in the US.  Ed. Note - I guess we can export bad work but don't want to see it here - the deadline for ceasing distribution to rest of planet is August 31st according to this article.

 

 

Posted by Bruce Lehr November 24th 2010.

EU Considers Guidelines for Biosimilar mAbs

This is another perspective on the EU's proposed guidelines governing biosimilar antibodies from the PharmaTech Talk blog.

PharmTech Talk » EU Considers Guidelines for Biosimilar mAbs.

As previsously posted here, the EU is expected to require clinical trials for biosimilar mAbs. The question is the extent of testing that will be required for mAbs versus other biosimilar proteins like EPO or HGH. A rituximab biosimilar is likely to be the first test case.

 

 

 

 

Posted by Bruce Lehr November 24th 2010.

US Biosimilar's Guidelines Far from Settled

The Patent Doc blog offers these comments from the recent FDA hearings toward the implementation of the Biologics Price Competition and Innovation Act (BPCIA).  Major discussions emerged around the following topics:

• Data exclusivity and "evergreening"
• Product naming issues and pharmacovigilance
• Post-market changes or drift in product

The debate on exclusivity came down to how strictly to interpret the 12-year exclusivity period. The innovators would like strict interpretation so that data exclusivity would be granted to products with any structural differences that lead to any change in potency, purity or safety.  Patient groups want more lenient interpretation to allow for minor alterations so a barrier to market entry won't be unduly erected to biosimilars.

Innovators want to see the EMA's preferred International Nonproprietary Name (INN) convention adopted that requires biosimilars to be assigned to a unique name that is globally recognized as different from the reference product, ie. make it harder to substitute. Biosimilar proponents want to see the FDA's National Drug Code and lot numbering system adopted.  This can be better used to track adverse events - and presumably show there are fewer than expected with biosimilars.  Plus INN numbers make it harder to gain insurer coverage, another reason innovators would be against this covention and for INN.

Post-market changes or product drift become important when looking at the question of interchangeability. Innovators suggest that drift could best be controlled by high interchangeability standards.  Biosimilar proponents want [EVERYBODY NOW] lower interchangeability standards.  They suggest the FDA use studies similar to what they use to approve process changes for currently marketed reference drugs.

The upshot is there is more work to do. FDA Commissioner, Margaret Hamburg said, "It's a complex challenge.  I can't put dates on our timelines for implementation."  It may take many months for the FDA to finalize its approval pathway.

Posted by Bruce Lehr November 23rd 2010.

USP says Globalization is biggest challenge for supply chain security

This recorded interview is from in-Pharma Technologist.com with USP scientist Desmond Hunt speaking with an interviewer at AAPS 2010 in New Orleans last week.

Globalisation is the main challenge to drug supply chain security according to USP scientist Desmond Hunt, who says greater collaboration is the key to maintaining product integrity

Globalisation is biggest challenge for supply chain security, says USP.

Hunt also suggested that such an approach would also fit with demands from industry regulators like the US FDA and EMA, which he said are actively seeking to improve quality across the entire global supply chain.

Posted by Bruce Lehr November 22nd 2010.

New EMA Biosimilar Guideline Expected to be Conservative

The EMA has adopted a new policy guideline for biosimilars that it expects to announce within a couple of weeks.  EMA watchers expect the agency to be conservative in its approach - for example requiring separate clinical trials for different diseases addressed by the same antibody. The guideline is entitled, "Similar Biological Medicinal Products Containing Monoclonal Antibodies".   It will be relased for a 5-month consultation period.

The EMA's press release states the guideline lays down the nonclinical and clinical requirementsfor MAb-containing medicines claiming to be similar to one on the market. The expected clinical testing provision to establish safety and efficacy of new biosimilars is expected to drive up costs and make biosimilar applications the province of only the larger competitors for now - like Teva, Sandoz or Hospira. See Fierce Biotech.

 

 

 

Posted by Bruce Lehr November 21st 2010.

 

India tightens clinical trial guidelines

India’s Central Drugs Standard Control Organization (CDSCO) has drawn up guidelines for regulators and sponsors to help tighten up clinical trial inspection procedures.  The stricter guidelines aim to increase the credibility and integrity of clinical trial data, helping increase compliance with drugs and cosmetics regulations. The CDSCO claims a tighter framework will provide direction for inspectors and CDSCO officers when conducting inspections of sponsors, CROs (contract research organisations) and clinical trial sites.

India tightens clinical trial guidelines.

CDSCO headquarters say “inspection of clinical trial sites would generally be pre-announced,” but insist that spot-checks may occur “under some specific circumstances”. Inspection of the CRO or trial sponsor can still be conducted without prior notice.

 

 

 

Posted by Bruce Lehr November 18th 2010.

Blogger View: Memo to Congress: Hands off FDA

Eric Greb, in The PharmTech Talk blog, discusses the possible consequences when the US House of Representatives passes hands to the GOP in January 2011.  With their stated cost-cutting agenda, every government department involved with domestic spending is at potential risk of cuts -- including the FDA.

PharmTech Talk » Memo to Congress: Hands off FDA.

However, the FDA is already straining under increasing levels of responsibility, e.g regulation of tobacco.  Moreover, a recent GAO report criticized the FDA's lack of oversight of foreign pharma manufacturing plants, the majority of which have never been inspected. 

The post questions the wisdom of cutting this department's budget if we want to keep the public health and safety secure. I would second the writer's opinion that there must be other areas where cuts can be better directed. 

The agency still stands as the last line of defense for the safety of the pharmaceuticals we take -- and there have been ample examples in the past several years of problems with raw materials in the supply chain and drug manufacturing sites where we need all the help that we can get.

 

 

Posted by Bruce Lehr November 15th 2010.

Big Pharma settlements with the Department of Justice - let's look at the scorecard

From PharmaGossip, we have a full accounting of the recent settlements between the US Department of Justice and Big Pharma companies -- for some sort of fraudulent or otherwise criminal activity. 

PharmaGossip: Big Pharma settlements with the DOJ - let's look at the scorecard.

The score stands with the DOJ collecting $5.3 B in fines for bad behavior. Although, I'm not sure what inning we're in?  Could be in for some more runs.

 

 

 

Posted by Bruce Lehr November 6th 2010.

Trade Association Comments from FDA Biosimilars Hearing

Here's a post from PharmaTech Talk blog that captures selected comments from the 3 major pharmaceutical trade associations - Pharmaceutical Reseach and Manufacturers of America (PhRMA), Biotechnology Industry Organization (BIO), and Generic Pharmaceutical Association (GPhA).

PharmTech Talk » Trade Association Roundup from Biosimilars Hearing.

As one might surmise, there are differing points of view on how easy the FDA should make follow on biologic approval, how products should be named/labelled, on interchangeability, and data exclusivity.  For your reading pleasure.

Also, here is the PhRMA press release  and GPhA press release from their websites.

 

Posted by Bruce Lehr November 4th 2010.