India's Biocon chief notes plans for biosimilar plays in EU, U.S.

Kiran Mazumdar-Shaw, photo courtesy of the Chemical Heritage Foundation.

Bangalore-based Indian drugmaker Biocon said it is a frontrunner in the biosimilar race in the European Union as well as the United States, citing its ability to get a nod earlier this year in Japan for a biosimilar of Sanofi's ($SNY) blockbuster Lantus (insulin glargine).

In a lengthy interview with the Business Standard newspaper, Kiran Mazumdar-Shaw, chairwoman and managing director of the company, said four biosimilars are slated for future regulatory approval.

"If the market is not crowded, the kind of share you can take and the opportunity in pricing you enjoy will be rewarding. For the four biosimilars--glargine, trastuzumab (Herceptin), pegfilgrastim (Neulasta) and adalimumab (Humira)--the market opportunity is $35 billion," she said.

The company last year said pegfilgrastim and adalimumab entered global Phase III clinical trials and a similar stage for trastuzumab is progressing in more than 100 sites around the world.

But she did note that there was a wait-and-see approach from investors. 

"For a long time, our stock was being crucified because they thought we would never be able to get into the so-called developed markets," she said.

"They felt it would be a long time before biosimilars would be allowed in those markets. Suddenly, it happened [the first U.S. biosimilar was approved in 2015 while the EU has allowed these drugs since 2006] and the floodgates are open now. Europe and the U.S. are embracing biosimilars. Now that we are the first among the early entrants, it gives us confidence."

Other firms in Asia are also quickly expanding into regulated markets with biosimilars, including this week as Incheon-based Samsung Bioepis has won approval from the European Commission for its biosimilar of Janssen's ($JNJ) major seller Remicade (infliximab), marking its second anti-TNF-α therapy in the region.

The biosimilar of infliximab, dubbed Flixabi, is indicated to treat rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.

Biocon, like Samsung Bioepis, will rely on marketing partners in those markets, she said, noting that a partnership with generic giant Mylan ($MYL) is key in that respect.

"Mylan has been an aggressive generic player in Europe and the U.S. They will be able to get into the market in a very different way. They have a huge portfolio of products, and they would be able to handle it better than us," she said.

- here's the interview in the Business Standard