Indian Biogenerics Market Heats Up

Although still tiny, the Indian market for biogenerics is attracting major industry players. Large Indian drug companies are gaining experience developing, producing, and selling generic versions of popular biologic drugs for local consumption while they await the adoption of regulatory standards in larger markets.

“It’s a gamble,” says Yusuf K. Hamied, the chairman and managing director of Cipla, India’s largest pharmaceutical company in terms of domestic sales. “Because of their higher prices, our biogenerics sales could one day exceed our sales of chemical-based drugs, but who knows?”

Cipla is ramping up production in a new facility at its Goa site on the west coast of India. The company is a relatively late entrant. Dr. Reddy’s Laboratories entered the biogenerics market in 2001 with Grafeel, a generic version of Amgen’s neutropenia treatment Neupogen. Dr. Reddy’s later launched a second biogeneric and has eight others in various stages of development. Meanwhile, Biocon, India’s biotechnology leader, is developing a range of biogenerics and has started clinical trials in India for its own version of Neupogen.

The companies are all getting ready to enter major Western markets. For instance, last June, Biocon signed an agreement with the generic drugmaker Mylan under which the U.S. firm would market Biocon’s biogenerics in the U.S., Canada, Japan, Australia, and the European Union. Biocon and Mylan note that the biologic drugs that will lose patent protection in those countries by 2016 are worth $25 billion in annual sales.

The deal assumes that the companies will find a way to gain regulatory approval for Biocon’s biogenerics in Western countries. But the U.S. remains largely closed to biogenerics from India and elsewhere because regulators have not yet finalized the standards by which they will approve competing products. So far, only a handful of biogenerics have been approved for sale in Western countries, mostly on a case-by-case basis.

The path to approval in India is clearer, says Sandeep Raktate, site manager of Biomab Pharmaceuticals, Cipla’s Goa-based biogenerics venture. “India has standards,” he says. “There are rules and regulations for biotechnology administered by an agency under the Drug Controller General of India.”

In addition to exporting drugs that are off patent, Indian companies can launch certain biotech drugs locally even if they remain under patent protection elsewhere. This is because the patent regime that India implemented in 2005 does not protect drugs patented before 1995.

Biomab hopes to get its first product approved for sale in India next year: a generic version of the Genentech breast cancer drug Herceptin. The need is urgent for a cheaper version of the drug in India, Hamied says. He points out that a single injection costs about $3,000 and that a full course of treatment requires at least a dozen doses. “Indians can’t afford these prices,” he says.

Biomab is considering the launch of generic versions of three other Genentech drugs: the angiogenesis treatment Avastin, the lymphoma drug Rituxan, and the asthma drug Xolair. The venture is also looking at Abbott’s arthritis drug Humira and Amgen’s colorectal cancer treatment Vectibix.

Entering the biogenerics market is a costly endeavor, Hamied says. No matter what standards Western countries adopt to approve them, producers will almost certainly have to prove via clinical trials the bioequivalence or biosimilarity of their drugs. Cipla will likely need to purchase about $3 million worth of Herceptin as part of this process, Hamied expects.

Biomab is a joint venture of Cipla and Desano, a Shanghai-based producer of active pharmaceutical ingredients that has been supplying Cipla for a number of years. Desano provides technology know-how, whereas Cipla has responsibility for global marketing because it has a better understanding of the marketplace than its Chinese partner has. When C&EN visited the Biomab site a few weeks ago, six Desano employees from Shanghai were stationed there.

In particular, Desano is supplying the Chinese hamster ovary cell lines used to manufacture the drugs. Because cell lines are so difficult to develop, they constitute a substantial barrier to competition, Hamied says, and are kept under high security at the Biomab site. Losing them would paralyze operations for several months until new lines could be shipped from China.

Biomab currently has only 350 L of production capacity, Raktate says, because the company is targeting just India at the moment. “The market is small in India; some of our competitors get started with only 50 L,” he notes. By 2012, when an expansion is concluded, Biomab will operate a site featuring 3,000-L and 5,000-L bioreactors. This expansion will make business sense only if Biomab can start to export its products, Raktate observes.

At Cipla’s headquarters in Mumbai, Hamied sees biogenerics as a potentially tremendous boost to the firm’s international sales, despite the regulatory uncertainties. “There is less competition in biogenerics than in chemical-based drugs,” he says. Perhaps so, but competition is already heating up in India.