Abbott’s FDA move could block Indian biosimilar manufacturers

May 7, 2012 7:10 AM

As we discussed here a couple of days ago, Abbott, the owner of rheumatoid arthritis blockbuster Humira, has filed a citizen’s petitition to the FDA, to ask the agency to block biosimilars. 

According to the Indian news source “The Financial Express” this move could dampen the prospects of Indian biosimilar manufacturers eyeing the US market.

In its petition, Abbott has urged FDA not to grant licences to any biosimilars, the applications for which were received before March 23, 2010. It was on this date that President Obama had signed the legislation (BPCIA) authorising FDA to approve biosimilars.

According to Financial Express, the Indian companies which are 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’.

“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.

“Abbott’s move would further delay the entry of Indian players into the US biological market. Indian companies would now adopt a different geographical trajectory (compared with chemical drugs) for expansion of their biological drugs. They are likely to launch first in the domestic markets, then other developing markets followed by EU countries and Japan and then consider the US market,” said Ranjit Kapadia, senior vice-president of Centrum Broking.

A senior executive from another leading domestic firm said to Financial Express that, “It took time for generics to find acceptance in the US. But once having found their rightful place, it is difficult to imagine life in the US without them. Similarly, biosimilars would have to earn their stripes in the US market.”

Some estimates reckon that biosimilars could help the US with potential cost savings worth $300 billion by 2029.


Source: The Financial Express

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