Tuesday, September 25, 2007


Biosimilar medicines


Gina S Krishnan

Biosimilar — biotech drugs that are alternatives to patented chemical entities — is one race where Indian pharma companies can still make a mark.

Europe opened its doors to biosimilars in April 2006 with Sandoz’s Omnitrope, which is a copy of Eli Lilly’s Humatrope, a human growth hormone. It was followed by another copy, Swiss drug maker Biopartner’s Valitrop. This year, three biosimilar versions of Johnson & Johnson’s Eprex — all by Sandoz — were approved by the European Medicines Agency (EMEA).

Closer home, Dr. Reddy’s Laboratories (DRL) also plans to launch its products in Europe. It had launched Grafeel in 2006 in Brazil. And it recently launched its second product, Reditux, an antibody for treating Non Hodgkin’s Lymphoma in India. DRL is in the process of filing for the launch of Filgrastim (Grafeel) in Europe. Betapharm, its subsidiary in Europe, will be its conduit to the biosimilars market. DRL’s Managing Director Satish Reddy had earlier told BW the company had a pipeline of seven biosimilars and would launch at least one every year.

Meanwhile, two of the world’s largest biotech companies —Biogen and Genzyme — have quietly entered India. More than a potential market, India also has a pool of scientists for clinical development of new products.

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