Abbott’s FDA move could block Indian biosimilar drug cos

Innovator firm Abbott Labs has moved the US Food and Drug Administration (USFDA) and has urged it to block a lion's share of the existing biologicals market from generic versions or biosimilars as they are commonly known. The move, if approved by the USFDA, could dampen the prospects of Indian drugmakers eyeing the US market.

In its petition, Abbott has urged USFDA not to grant licences to any biosimilar drug firm, the applications for which were received before March 23, 2010. It was on this date that US president Barack Obama had signed a legislation authorising USFDA to approve biosimilars, thereby, creating a regulatory pathway for generic drugs — 'highly similar' to already licensed biological drugs.

Experts and domestic pharma companies fee that irrespective of what decision USFDA takes, Abbott move would open doors to a long-winding and complex litigation process. It could also affect future plans of those companies already marketing biosimilars in places other than the US. Companies likely to be affected include Dr Reddy's, Biocon, Bharat Biotech, Serum Institute of India, Wockhardt, Lupin, Cipla and Glenmark.

In 2009, PwC had valued the US biological market at $69 billion, accounting for over half of the global biologic drug market.

Abbott argues that research and development of such products is expensive and a firm spends over $1 billion and a decade to develop such a drug. The clinical data generated after such investment qualifies as 'trade secret' and to use such data to bring competitive product to the market would be 'unconstitutional'.

If USFDA and subsequently courts agree with Abbott's position, at least one goal of US health reforms — to lower healthcare cost by making cheaper generic drugs available in the market — may be jeopardised.

"In essence, such a move could subvert efforts that made in the US to reduce healthcare costs by means including adoption of low-cost generic drugs, or in this case, biosimilars. This comes at a time when a clear regulatory framework in the US for the use of generics or biogenerics is yet to evolve. Through this move, the innovator company is trying to extend protection of its data rights for its biological drugs quite akin to how innovator companies protect their patent coverage through 'evergreening' against generics," said Vivek Mittal, chief legal officer of Lupin.

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