For the biotech firms in India, it has become strategizing time. They see a huge opportunity up for grabs if the facts and numbers on the much-hyped biosimilars market are for real.

The generic equivalents of biotech drugs, or the so-called biosimilars, are fast gaining currency across the world even as biotherapeutics look to outpace their chemical counterparts with the promise of greater safety and better efficacy.

As many as 30 biotherapeutics totaling $51 billion in sales are set to lose patent exclusivity by 2015. This will make the global market for biosimilars leapfrog from $243 million in 2010 to $3.7 billion, says a report by Datamonitor Group Plc, a market analysis firm.

Analysts believe that cost-effective biosimilars have great potential, as they can rapidly substitute highly expensive brands. Globally, generic majors including Teva and Sandoz have already listed biosimilars as a priority casting their eyes on some of the key, blockbuster biologics.

In India, there are not very many pure-play biotech companies; those with the prowess to produce biosimilars are even fewer. Yet, hailing from the land of generics, select firms have already made considerable dents in mastering recombinant technology, the cornerstone of a big chunk of biotherapeutics.

Well-Positioned

Biocon Ltd., for example, has successfully commercialized human insulin and insulin analogues into several global markets. Biocon has a portfolio of monoclonals as well. “With patents for eight of the top 10 biggest-selling biotech products in the U.S. set to expire by 2018, a sizeable market has opened for biosimilars,” said Kiran Mazumdar-Shaw, chairman and managing director of Biocon. “Biocon is well-positioned to seize the opportunities in this space, having set up the requisite structures and grown the enabling competencies.”

Armed with a biosimilar pipeline containing several programs and U.S. FDA-approved biomanufacturing plants, Biocon expects biosimilars to account for more than a quarter of the company’s revenues within five years.

The Bangalore-based firm entered into a tie-up with Pfizer in October last year for commercializing human recombinant insulin and three insulin analogues worldwide. The company has sales and marketing agreement with Mylan to develop and commercialize molecules to treat cancer and auto-immune disorders. Biocon also holds 70% stake in AxiCorp and plans to leverage German company as a launchpad to expand biosimilar activities in Europe.

For Biocon, novel biologics is part of long-term strategy. “We have a short, medium, and long-term market entry strategy with strong capabilities in biosimilars, generics, and biologics,” explained Ms. Shaw. The strategy is to maximize development in India by taking advantage of the lower R&D costs and faster development timelines to commercialize products rapidly in India and emerging markets. Expensive global development will be pursued once the risks are mitigated.

It’s not only first-gen bio-drugs, but also more advanced products that figure on the list. Dr Reddy’s launched a biosimilar version of darbepoetin alfa, probably the first of its kind, in India in 2010. This Hyderabad-based firm has already commercialized generics of filgrastim and rituximab.

India Launch: The Acid Test

At least one more darbepoetin alfa biosimilar is expected to hit market this year from Avesthagen, a notable biotech firm from India’s biotech hub of Bangalore. “Avesthagen has a rich pipeline of biosimilars through which we intend to provide cost‐effective healthcare solutions to patients across the globe,” Villoo Morawala-Patell, founder and CMD of Avesthagen was quoted as saying while announcing clinical trials for the products.
Avesthagen has lined up BRIC (Brazil Russia, India and China) countries by 2011, EU and North America on expiry of current patents for darbepoetin launch.

Other firms that hold a biosimilar franchise include Intas Biopharmaceuticals, Wockhardt, Shantha Biotechnics. Intas Bio expanded its tie-up with Canada’s Apotex to market biosimilar version of peg-filgrastim in North America, EU etc. Headquartered in Ahmedabad, Intas Bio is reportedly in the process of setting up facilities for manufacturing monoclonals.

Wockhardt has insulins, epo and vaccine in portfolio while Shantha Biotechnics – now part of Sanofi Pasteur – markets streptokinase, interferon alfa, epo and other vaccines.

An acid test to establish the efficacy of the product, launching in India equips these players with enough data to pursue developed markets. Favorable generic regulatory environs and a large patient base are other conducive factors. Bio firms, led by the Association of Biotech Led Enterprises, is now pitching for more simplified and faster process for the approval of biotech drugs to further the growth of biosimilars.

No clear regulatory pathway is in place for approving biosimilars in the world except in Europe. The U.S. is finalizing on the guidelines, while countries such as Japan are in works to make the biotech copycats more acceptable.

However, the question whether Indian generic leaders will be able to recreate the magic they had with small molecule drugs in biosimilars remains open.

S. Harachand is a pharmaceutical journalist based in Mumbai.He can be reached at [email protected].