Pharma cos gear up for biosimilar ‘stampede’

Does the next wave of opportunity on biosimilar drugs hold out good prospects for Indian drug companies? 

An estimated $ 55 billion worth of biosimilar drugs are expected to go off patents by 2020, and this opens the floodgates for Indian drug companies to partner, develop and manufacture such products, said Charu Manaktala, Senior Medical Director and Head of Clinical Strategy, Strategic Drug Development with Quintiles Asia, a multinational clinical research organisation.

Some Asian companies have already tasted success in the global landscape, she said, adding that companies were taking the development of their products to the global arena, rather than limit themselves regionally.  Indian companies though will have to contend with Korean and Japanese companies who are active in this landscape.

Biosimilars are “highly similar” versions of an approved biological drug. And they are complex, sensitive and more difficult to make.

At least 160 biosimilars are in different stages of development for the top six selling biologics, said Manaktala, outlining the second wave of opportunity.  In fact, there are early signs of interest in the third wave of biosimilars as well, she added.

The products whose patents expire between 2015 to 2020 include Humira, Enbrel, Rituxan, MabThera, Avastin, Herceptin and Remicade.   Companies of all hues, including traditional big pharma, generic drugmakers biotech players and new entrants are joining this biosimilar “stampede”, Quintiles said.

Pricing efforts

Both the innovator companies and those that make the biosimilar products are making every effort to capture the market, she said, referring to the trastuzumab example in India. The breast cancer drug saw the innovator (Roche) drop price and partner with Indian companies to stave off competition from other Indian companies on the drug.

Similar pricing discounts and partnerships were seen in other markets as well, she indicated, citing an example in Norway where the biosimilar product (Remsima) was given at a 70 percent discounted price in tender-driven purchases, from the initial discount of 40 percent. And this pushed up marketshare to 55 percent from less than 10 percent.

Evolving regulations  

The global regulatory environment on biosimilars too is constantly evolving, faster than any segment in pharmaceuticals. And the coming year expects to see guidance from the United States Food and Drugs Administration on labelling of these products, as compared to the innovator’s products. In the EU, where about 21 biosimilar products have been approved over the last 10 years, industry players point out that additional labelling was not required, she said.

China finalised its biosimilar guidelines in March and the Indian guidelines of 2012 too are in the process of revision, expected to be released for stakeholder review shortly, she said, outlining the global regulatory landscape.

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