Biocon Looks To Push Biosimilars In US and EU Markets

Biocon Sees an Opportunity Pushing Biosimilars In The US

Bangalore-based drug maker Biocon is claiming it is leading the way in the race to market biosimilars in the European Union and the United States.

The increasing involvement of Asian companies has been a notable trend in the biosimilars market in recent months. In May this year, Incheon-based pharmaceuticals company Samsung Bioepis gained the approval of the European Commission to launch a biosimilar of Janssen’s top selling drug Remicade (infliximab), called Flixabi. Flixabi is used in the treatment of a range of diseases.

Biocon appears to be at the forefront of this trend and has hopes of gaining approval for four biosimilars in the coming months. According to Biocon chairwoman and managing director, Kiran Mazumdar-Shah, the company is posed to exploit a lucrative opening in the US and European biosimilars market: “If the market is not crowded, the kind of share you can take and the opportunity in pricing you enjoy will be rewarding,” she said.

It is believed that the four biosimilars – glargine, trastuzumab (Herceptin), pegfilgrastim (Neulasta) and adalimumab (Humira) – could represent a market opportunity of around $35 billion.

The drugs are not far from being ready to bring to market. Pegfilgrastim and adalimumab have already entered what are known as Phase III clinical trials, and development of trastuzumab is believed to have reached the same stage.

The rise in Asian involvement in this market represents vindication for Biocon, as the company has had to battle investor skepticism for some time.

Western Reluctance Of Biosimilars Has Melted Away

Initial reluctance on the part of  US regulators towards biosimilars has given way to acceptance. The European Union has permitted biosimilars since 2006 and the first US biosimilar was approved last year. Being among the earliest to the new market gives Biocon an advantage. Biocon has also benefited from a partnership with US company Mylan. The generic giant has a wide range of pharmaceutical products and can help the Indian company to properly market their biosimilars in the US.





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