The Big Red Biotech Blog

April Fool - No Patent for Gleevec in India

Fierce Biotech also reports today that the Indian Supreme Court rejected Novartis' bid for a patent on its cancer drug Gleevec.  The court said the extended release form of Gleevec, which has never had an Indian patent, failed to meet a hurdle as a new subsance with increased efficacy. Effectively they ruled this represented an instance of "evergreening" by Novartis and rejected its application under section 3(d) of Indian Patent code.

Consumer advocates and biosimilar producers hailed the ruling as a victory to make this drug more available to the Indian populace.  Novartis said it the ruling provided heavy disincentives for it to invest in any more R&D work in India and implied it would think twice before marketing anything in India without patent protection secure in hand.

If this became a more generalized phenomenon experienced by other multi-national companies in India, will they as a group choose not to market some of their newer products there?  If so, does that mean India will be increasingly relegated to using older (and cheaper) versions of drugs that have had their IP expire effectively.  I'm not sure.  One could argue this would have a long term negative effect on what is offered for sale in India.  On the other hand, people can't use a drug they can't afford to buy in the first place, now can they?  This will be worth watching.

In the Fierce Biotech piece, it was also noted that the UK had passed some new tax provisions that will favor R&D investment in the UK -- effectively reducing tax rates on profits from patented products.  There is also an above the line tax credit of 10%.  The new provisions called the Patent Box were hailed by the BioIndustry Association (BIA) as being a new spur for R&D investment in the UK -- instead of a place like say India.

Investment may well swing back toward the UK, at India's expense for example.  But something like this to me is less likely to sway India R&D investment decisions, than the aforementioned patent ruling -- which in itself is less likely to effect R&D investment I think than it is to affect decisions on what products to actually introduce and market in India. That's just me.

Posted by Bruce Lehr Apr 1st 2013.

 

 

India and China Start Ups?

Here's a post from In the Pipeline discssing latest information on status of VC investment in biopharm R&D with start ups in India and China.  Conclusion?  VC activity is still fairly low by comparison to US standards.  The study author's estimate was that approximately $1.7 B had been invested in 116 firms over the past 12-13 years.  By comparison, the US industry would expect about that much investment activity per quarter. 

No where to go but up -- and that does appear to be the direction in which things are moving -- albeit slower perhaps than one might imagine.

Posted by Bruce Lehr Mar 8th 2013. 

India May Drop Compulsory Licenses Based On Price

Does it really matter?  It appears that India will no longer issue compulsory licenses to generic or biosimilar manufacturers to make a patented drug based solely on whether that patented drug's price is perceived to be too high.  Good news for the multi-nationals right?  They seem to think so.

India May Drop Compulsory Licenses Based On Price // Pharmalot.

Instead India has set up a new Committee to set pricing for patented drugs by comparing to prices negotiated between manufacturers and governments in US, Canada, France, Australia and New Zealand.  The thought seems to be this comparison will lead to higher prices than what consumer advocates in India would like to see but less than what pharma companies would charge on their own, but woud still be acceptable to these same companies.

But....the Committee would take per capita gross national income (GNI) and purchasing power parity in these countries into account.  The ratio of GNI in comparison country/GNI in Indiawould be calculated and used to adjust the price of the medicine for India from that of the comparison country.  This adjusted price would also serve potentially as the starting point for future reductions.

Ok. No compulsory licensing. Yes to a Pricing Committee.  What if they price products lower that what pharma is expecting?  Are we back where we were?

Posted by Bruce Lehr Mar 1st 2013.

India's Government Targets Cancer Drugs

India's government has been rattling sabres for some time with regard to high priced drugs and compulsory licenses.  Now they will go after three more cancer drugs and their makers to force licenses.  The drugs are Roche's Herceptin (breast cancer), BMS' Ixabepilone chemotherapeutic agent, and Dasatinib for leukemia. 

Last year, the government forced Bayer to give a compulsory license for its Nexaver (kidney and liver disease).  The drug's price dropped by a whopping 95% in country after the generic maker Natco Pharma took a license.

This is all about the price Western companies charge in India for cancer meds.  Herceptin is priced at $1400 per month, Ixabepilone is similarly priced and Dasatinib is priced at $300 per month.  These are out of the reach of India's common man.

One enthusiastic oncologist was quoted , "It's a very good move and will not just benefit Indians but possibly also bring down cancer drug prices in countries where the pharma market is not controlled by the US and western European countries."

Said another patient advocate from the group Knowledge Ecology International, "Companies like Roche have cut prices of Herceptin in the past but the price cust has been a joke."

So there continues to be a strong backlash against western style pricing in emerging markets like India. This will no doubt result in companies having to re-evalute their competitive strategies in these markets -- and certainly will affect the profits they can expect.  The so-called pharmerging markets are fighting back more frequently now and may not be the panacea once supposed for Big Pharma struggling to gain new profits to make up for those that have gone over the "patent cliff".  India, for sure, is not cooperating so far. See Pharmalot.

Posted by Bruce Lehr Jan 15th 2013.

India Bringing Drug Price Controls to the Plant Level

The Indian Government seems to be going overboard in its efforts to control drug prices.  They are apparently not content with only compulsory licenses, patent rejections, biosimilars incentives, anti-gouging measures, abolishing brand names and even arm-twisting by their Supreme Court -- now they want to have inspectors visit manufacturing plant to assess production costs.

NPPA to inspect Indian drug plants as part of pricing role.

Drug marketers must be pulling out their hair there.  Marketing 101 says you should price your product or service based on its value to the market -- not on production costs. Egads!

Instead, the National Pharmaceutical Pricing Authority (NPPA) will visit manufacturing facilities to look at things like yields, capacity utilization, maintenance of plant and machinery, cost of raw materials, R&D expenses, plant expansion and machinery replacement. The NPAA will up its oversight from 74 bulk pharmaceuticals to 348 bulk drugs.

The underlying motivation seems to be an "effort to get drugmakers to justify the prices they charge for products based on production costs." Double Egads! Wonder what drug company investors and shareholders think of that?

Anyone still think India is really lucrative new drug market for the MNCs to enter? Volume basis maybe, but what about margins?

Posted by Bruce Lehr Nov 8th 2012

India: "Roche, Let Me Have that Patent Back!"

India continues it adminsitrative attack on drug makers' IP.  The Intellectual Property Appellate Board revoked the patent on Roche's Pegasys hepatitis C treatment.  Maybe they don't like flying horses? In fact, they didn't like Roche's patent extension from pegylating the drug and said it didn't enhance efficacy compared to existing treatments. This will open the door to cheaper generic alternatives in India.

India Revokes Patent On Roche Hepatitis C Drug // Pharmalot.

This is India's second override of a big pharma company's patent. Earlier this year, Bayer was forced to grant a compulsory license to Natco for Bayer's Nexavar cancer med.  In both cases, one of the main issues seems to be the perceived high price of the innovator medicine compared to what generics competitors would offer in the market.  This is a big deal to movers and shakers responsible for India's healthcare policy.

"This victory will facilitate early entry of generics which is likely to lower prices.  If this happens, millions suffering from hepatitis C, both in India and globally will benefit," said Anand Grover, senior counsel and director of Lawyers Collective HIV/AIDS Unit (a patient advocacy group).

Not only are we targeting lower prices in India but apparently for the World too!  A Roche spokesman retorted that the company remained "concerned that a policy of neglect for patent rules would inhibit research into future treatments." No Drugs for You, India.

Posted by Bruce Lehr Nov 6th 2012 - Get the Vote Out

 

India Gets Tougher on Drug Pricing

India has been particularly concerned with high pricing of drugs in its market.  They have previously activated compulsory licensing sanctions, denial of patents (evergreening in particular), and incentives for generics/biosimilars -- all aimed at keeping prices down to the consumer and the government payer, and promoting more competition (IP possibly be damned).

The latest from India .

Now, they are raising the ante on drug makers they consider to be overcharging (gouging I suppose). The new policy and penalty?

Any drug maker found overcharging will have to shell out the entire sales revenue of the medicine from the date of its launch as penalty, according to a directive issued by the country's drug price regulator.

"If a company has not been booked for overcharging for selling the product without price approval, if any, pertaining to the period prior to fixation of the price of the said formulation, the entire sale amount from the date of introduction of the product till issue of the price notification order shall be recovered from the company, treating the entire sale proceeds as 'unauthorised sales'," the National Pharmaceutical Pricing Authority (NPPA) said (in fluent government-ese).  Zounds!

The regulator said that action will also be taken in cases where the manufacturer and marketing company have failed to take prior price approval for sale of scheduled formulation packs. The NPPA has given state governments the authority to initiate legal action against companies found overcharging. While welcoming the move experts have raised apprehensions over the efficacy of the directive.

Experts don't seem to be concerned about the policy, they seem to be concerned with the ability to enforce. Double Zounds!

Posted by Bruce Lehr Oct 26th 2012.

 

Indian Drugmakers Fight No Brand-Name Rule

Earlier this week, I described the India drug controller's, GN Singh, plan to prohibit the use of brand names in selling drugs.  This is an effort to promote generics' use to reach a greater portion of the population and to save money for the government.  I had the impression that it was aimed at the multi-nationals operating in India.

Indian Drugmakers To Fight Brand-Name Rule // Pharmalot.

However, the local Indian Drugs Manufacturer Association is the first to voice a vehement dissenting response to this concept.  They contend the controller has NO jurisdiction on the use of brand names and pledge to fight this legally if necessary.

"Just as you cannot tell a carmaker or a chocolate maker to stop branding their products, you cannot ask pharma companies to do away with branding their products," said Vinay Pinto, managing director of Wallace Pharma. 

Ironically, the trade association that represents foreign multi-nationals is taking more of a wait and see approach.  The government has indicated a desire to get comment on this proposal and the MNCs want to participate in that exercise first. This story has more to come.

Posted by Bruce Lehr Oct 19th 2012.  

India Serious About Pushing Generics

Are you a Big Pharma Compnay looking to make up sales shortfalls in emerging countries?  Well, scratch India off your list of profit centers.

India Pushes To End Sale Of Branded Drugs // Pharmalot.

India's drug controller, GN Singh, wants to prohibit the sale of branded pharmaceuticals in India in favor of lower cost generics.  States have been ordered to stop issuing licenses for manufacturing licenses for drugs under brand names. Manufacturers have been asked to submit their products for licensing under generic names -- not brand names.

"We have sent the order to all state health secretaries asking them to instruct their drug licensing issuing authority to issue licenses only on generic names and not on branded or trade names, which is the usual practice now.  A branded drug can be 10 times more expensive than a generic variant," said Singh. In addition, the government will open its own chain of medical stores to make generics available at a reasonable cost.

They seem to be as serious as a heart attack in cutting drug costs in India.

Posted by Bruce Lehr Oct 17th 2012.

Uh-oh! Indian Court Says Your Price is Too High to Novartis

Forget the resolution of the patent dispute.  Who cares if Novartis is able to get its patent for a new form of Gleevec (Glivec in India)?  The Indian Supreme Court today asked Novartis lawyers to tell their client to lower its prices.

One justice called the existing pricing of Glivec "shocking" and complained drug prices are already too high in India. 

Indian Court To Novartis: Lower Gleevec Price // Pharmalot.

Novartis says that it has one of the most active and largest donation programs for the poor amongst drug companies.  Their attorney said the company did not want to "profiteer without a conscience". 

The Supreme Court said their donation plan was a "complicated scheme for idenitifying those who are entitled to given free meds and those who can afford to pay 80 days of the annual cost of Glivec."  The Court said Novartis should earn goodwill by lowering its price.

Egads!  That doesn't bode well for Novartis' case does it?  What's more? It is another indication that big pharma won't necessarily be able to go to emerging markets to drive revenue gains. India, in particular, is being very aggressive in sending the message that high prices for cancer meds aren't going to be tolerated -- whether that translates as a direct request to lower price or a grant of a compulsory license to a local generic manufacturer (see Bayer Nexavar). 

Posted by Bruce Lehr Sep 12th 2012

Natco Not Satisfied with One Compulsory License

Earlier this year, Natco convinced the government in India to grant it a compulsory license to Bayer's Nexavar.  Apparently, one is not enough.  Natco seems to be planning to bolster its pipeline further by going after more compulsory licenses.  But the company is remaining mum as to which companies' drugs it covets.

Natco Seeks More Compulsory Licenses In India // Pharmalot.

Has the lid been lifted to Pandora's box?  I don't know but it sure looks like Natco is going to try to cash in but filing application after application to the India government to grant it licenses?  Afterall, what does Natco really have to lose by doing so?  This coudl be a good example of a policy gone wrong.

The US Patent and Trademark Office and the World Trade Organization have already come out against granting these licenses. Presumably, if the Indian government should issue more, than even more Western pressure will increase against these.

Many experts in India pooh-pooh the prosepects of compulsory licensing becoming a major factor.  They point to the difficulty in making the case "that the multi-national drug maker failed to implement a strategy to make a life-saving medicine available to those who are unable to aford it."  They also note that invalidating a patent would be cheaper than the compulsory license as no royalties would be owed. The latter point may be true, but how easy is it to win an invalidation of patent? 

Seems like a slippery slope to me, if Western companies can't rely on patent protection for their products in India, I would expect them not to market those novel drugs in that country.  That wouldn't be good for anyone -- drugmaker, government or patients.

Also, isn't it a bit offensive for a company like Natco to talk about potential additional comulsory licenses as "its pipeline".  What did it do to invent anything to help the patients?

Posted by Bruce Lehr Jul 23rd 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.

India launches 'similar biologics' guidelines

The Indian Government launched its biosimilars guidelines at this year's BIO meetings. The guidelines are aimed at providing a "clear" regulatory pathway for manufacturers of biologic similars and will be applied to new filings now.

India launches 'similar biologics' guidelines at BIO2012.

Manufacturers must prove similarity to a reference product -- either an innovator drug in licensed in India or approved elsewhere.  There is also a requirment for 4 years post-market surveillance on safety data.

The motive for India to promote these guidelines is to encourage more domestic and foreign investment in biosimilars in India with an idea to increase product access and to reduce4 goverment spending on drugs.

Dept of Biotechnology secretary, Maharaj Bhan,  said,  "India needs drugs at reasonable prices so we have to worry about the issue of access so we have to spur innovation and manufacturing in India.  We also need to create an environment where International companies will be interested in using India as a place to manufacture drugs."   The latter comment relates directly to the previous blog post on India's need to raise GMP compliance.

Posted by Bruce Lehr Jun 25th 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.

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.

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.

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.

GE Enters Turnkey Bioplant Partnership for Emerging Nations

GE and engineering firm, M+W Group, announced that they will team up on a complete biomanufacturing plant development service to serve the growing global demand in the emerging markets. The partnership will provide a single point of contact for customers, primarily governments, including IP access, financing, plant start-up, construction, and staff training. 

GE wont say if turnkey bioplant partnership will cut prices for emerging nations.

The partnership's goal is (to make money) to aid emerging nations in satisfying their unmet needs for the biological products that are predicted to have major positive health impacts. The regional focus of the partnership will highlight the Middle East, Central and Latin America, and SouthEast Asia. They will also sell to Big Pharma looking to upgrade vaccine manufacturing capabilities in emerging nations.

Posted by Bruce Lehr Dec 19th 2011.

 

Rise of Asian biopharm creates investment targets for Quintiles

Quintiles says it plans to invest more in Asia as the biopharm industry continues to develop rapidly over there.  

Rise of Asian biopharm creates investment targets for Quintiles.

Anand Tharmaratnam, head of Asia markets at Quintiles, said that global biopharm companies accounted for 90 percent of Quintiles clients in Asia only 3 years ago, whereas the ratio of global to local clients is now closer to 50:50 today. That's a dramatic shift in only 3 years.

Tharmaratnam attributes the rapid growth to government support and return of highly qualified staff (with an entrepreneurial bent) from the US.  Korea, Singapore and Taiwan in particular were singled out as biopharm hotbeds.  The rapid growth in India and China has also stimulated global pharma companies to locate more and more operations there to open up these potentially lucrative markets. 

Anyone think the US needs a policy to further promote US Biotech growth and industry health to maintain our current leadership position?  Or can we just watch Asia grow at our expense?

Posted by Bruce Lehr Dec 1st 2011.

India - No Cap on Foreign Drug Company Investment

India's policy makers had been contemplating putting a cap of 49% on foreign drug maker's ability to buy Indian drug companies, but decided not to go that route.  The policy discussion had been kicked off by the fact foreign companies had increased their share in India's drug market from 15% to more than 25% in the past three years.  It was feared that foreign drug makers would not have an interest in supplying affordable medicines to India's poorer citizens.

India Will Not Cap Foreign Investment In Pharma // Pharmalot.

However, a different compromise has been struck.  Foreign Investment instead of being capped will be closely scrutinized by India's Foreign Investment Promotion Board which will itself be overseen by the Competition Commission (anyway see any hints of previous British rule in this bureacracy?).  It seems terribly bureacratic to me, but all the key players seem happy from global multinationals like Pfizer to the domestic trade group Indian Pharmaceutical Alliance.

So who am I to criticize?

 

 

 

 

Posted by Bruce Lehr Oct 11th 2011.

Sanofi Bets on Vaccines in India

According to Chris Viehbacher, CEO Sanofi, India is the place to be for Sanofi to capture 40% of its sales from emerging markets by 2015 -- as compared to only 29% now. Thus, Sanofi acquired Shantha Biotech for 550 M euros in 2009, and plans to invest another 220 M euros in a new Hyderabad vaccine facility.  The facility -- touted to be Asia's largest -- is slated to open its doors by March 2012.

Sanofi is targeting vaccines as one of its 6 key initiatives to help replace the 1/3 of its sales and 50% of its profits that it will be losing through patent expirations.  One of the other key initiatives is to grow fast in the emerging markets. So building a new vaccine plant in India couples growth plans between vaccines and emerging markets.  See European Biotechnology News.

 

 

 

 

Posted by Bruce Lehr Oct 10th 2011.

India May Cap Foreign Investment In Pharma

India has been worried about protecting its domestic pharma industry from MNC takeover for several years now -- especially as foreign buying companies have grown their market share to more than 15% in the last couple of years.

India May Cap Foreign Investment In Pharma // Pharmalot.

A high-level government think tank called the Planning Commission now has recommeded that India cap foreign investment in drug manufacturers to less than 49% rather than allow up to 100% investment as is theoretically possible now. Ostensibly this is to protect India's poor populace from being priced out of the market when the evil foreigners take over. This does not bode too well for foreign investment in India. Other members of the government argue that such protectionism is retrograde policy making -- and a few more forward looking Indian companies, like Biocon, say bring on the competition. 

Its chairman, Kiran Mazumdar-Shaw says, "Companies will do what makes business sense for them. This is a high-growth sector and you will devalue it if you start putting restrictions."

It's worth noting that India makes more than 20% of the world's generics now and its industry is expected to grow from $19 B in 2009 to $50 B by 2020.

 

 

 

Posted by Bruce Lehr Sep 27th 2011.

 

Indian & China Drug Makers Talk Biosimilar Smack

Again, as reported in Fierce Biotech this morning, a number of Indian and Chinese companies have invested heavily in new facilities aimed at making biosimilars.  And, according to the article, are aiming to introduce these new drugs to the emerging world for as little as 1/3 the price.  This challenges conventional dogma that biosimilars due to their more complex nature will be unlikely to see much more than 20% or so price discounting when introduced. 

Dr. Yusuf Hamied however is quoted as saying the 33% of current price (i.e. 66% discount) point is possible.  He doesn't stop there. "Once we have recovered our costs, our prices will fall further," he told the NY Times, "A lot further."

Hamied wasn't talking about only the current crop of cytokine type biosimilars either.  He was referencing blockbuster mAbs for cancers or rheumatoid diseases -- like Herceptin , Avastin, Rituxan and Enbrel.

This will be an interesting battle looming as many Western companies have also begun to set up shop in these countries under the assumption that they can introduce these drugs to new markets and earn some bucks to make up for falling revenues due to generics in the traditional markets. If they catch a lot of price competition in these new arenas, that may render the whole strategy moot. And as the Fierce piece concludes -- if the beach head is established in the emerging world -- what will be the FDA justification for keeping these drugs out of the US at dramatically lower prices? Especially given the likely pressures we will see on health care budgets.

The saving grace may well be that the emerging producers will NOT find it so easy as they believe to copy these medicines.  We shall see.

 

 

 

Posted by Bruce Lehr Sep 19th 2011.