Pure-play global biologics firms have long pleaded with the government for a tighter regulatory framework for approval of biosimilars in India. Companies like Amgen, Biogen and Genentech (now part of Roche) have some of the biggest successes in biological drugs and could be naturally worried about the way copied drugs are approved and sold in India.
Is there enough data to suggest the safety of biologics in India? When cell lines are changed, product safety and efficacy gets affected, said a senior executive with one of the largest biotech companies, wondering if the present set of regulations in the country was enough.
Many years ago, Piramal Healthcare, which was then manufacturing filgrastim on behalf of Roche, picked up a big fight on the safety of a generic version of the drug launched in the market by Dr Reddy's. Finally, Dr Reddy's had to undertake changes in the product and re-launch it.
Manufacturing of biotech drugs is set to grow very strongly in India from around $200 million to nearly $600 million in the next four years and so corporate dialogues are on for strategic alliances. This does not include the imported drugs that are gaining a larger share despite being sold at exorbitantly high prices.
Among Indian companies, Wockhardt seems to have a range of capabilities in manufacturing biotech drugs. It has been successful in putting insulin and insulin analogs in the Indian market besides interferon.
Biocon, too, is a big contender for the top spot in biotech drugs. An executive from the top league explained to audiences who attended a conference on biosimilars that bigger Indian players are aware of the consequences of a badly produced drug and are sticking to international norms, but he suspected there are a few others who may not be as interested in the drugs as in making fast bucks.
A company that fights the odds of high failure rates and burns top dollars to bring a new drug to the market knows how tenacious it is to develop a biological compound. After all that, if questionable copies chip away future market share, it has an agonizing effect. There is uneasiness on future investments in a market that does not have its legal framework right.
As is documented many times, future approvals will be mainly for drugs derived through living cells as against synthetic chemistry based compounds. And so the lines between pharma and biotech companies will blur.
More and more pharma companies are lapping up early stage discovery compounds in biotech, but not much action is seen in the Indian context.
To be ideal partners for large-sized biotech companies, Indian companies should set higher quality benchmarks. They need to go beyond the commoditised biologicals like insulin, G-CSF or interferons and aim for the next wave of monoclonal antibodies. As many biotechnologists say, it may be better to invent a new drug than waste efforts on copying one.
Vaccines have been a traditional stronghold for companies like Serum Institute, Panacea, Shantha and Bharat Biotech as they have achieved ideal stability levels for many difficult to manufacture combination shots.
Opportunities are now unfolding for adult vaccines for cervical cancer and a few other cancer types. With a tag of being cheaper by at least a half, Indian companies can be attractive partners for global biotechs. Companies like Biogen and Genentech have made rounds in India to find a good partner, but they may have dismissed any alliance mainly on two grounds — lack of cutting-edge scientific expertise and limitation of scale.
Many Indian scientists working in the US are keen to come back to India, but the conditions need to be ideal. If Indian firmscan bet bigger than their present vision, India will have the same talent pool that is helping the bigger MNCs discover drugs.
The first patent expiries will be on erythropoietin in the next 3-4 years. There is still time for Indian companies to prepare the ground and seize the opportunity before Chinese entrepreneurs take a lead, so convincing that it will be difficult to match later.