Considerations about the exclusivity period of biologicals

INICIO/Noticias Farmacéuticas | Posted 19/01/2010 post-comment0

A proposal by US Democratic Representative Anna Eshoo included in the US House health reform bill, would give developers of innovative biomedical drugs 12 years of data exclusivity from generic competition, significantly extending their patent rights, writes Los Angeles Times columnist Michael Hiltzik.


He explains that biological drugs differ fundamentally from conventional pharmaceuticals and that follow-on biologics will be ‘biosimilar’ but not identical to originator biologicals. “So some experts doubt biological follow-on biologics will ever be as competitive or cheap as today's generics. That's a point in favour of giving follow-on biologics a leg up, say by limiting the exclusivity period”, he writes.

The US Federal Trade Commission (FTC) weighed these issues and concluded in June 2009 that the 12-year period was too long – the cost of developing follow-on biologics would be so great and their chance of cutting into originators' market share so limited that drug companies would have plenty of incentive to innovate even without it. The FTC report, which was based on an industry workshop the agency held in 2008, gets cited constantly by the generics industry, so according to Mr Hiltzik it is not surprising that it drives supporters of Ms Eshoo's bill nuts. When he asked Ms Eshoo about it, she reacted so strongly you would think he had bit her in the leg. "It was laughable", she said, "not something done by people who really understand the issues".

He writes that what makes this debate more than a sideshow is the amount of money at stake. The drug industry in general is not shy about scattering cash about in Washington – a study by the website recently linked Big Pharma's campaign donations to the death of a US Senate measure easing the importation of cheap drugs from Canada. Its stepchild, the biotech industry, is a fast learner: It has made roughly US$3.8 million in campaign donations since 2003. Ms Eshoo is the top recipient in the US House.

Mr Hiltzik argues no one can be sure how best to spur innovation and competition in the still-novel biologicals industry, but what we do know is that some of the same arguments heard today in favour of high barriers to generics were mustered against Hatch-Waxman in the 1980s, and the pharmaceutical and generics industry have both thrived. At the moment the 12-year rule is in the healthcare reform bills in both Houses of Congress, and the chances are slim it will get a closer look. “By the time the lawmakers are done dickering over the big questions, they'll be too exhausted to pay attention to anything else”, he concludes. (see also US regulators should catch up with Biosimilars Pathway and Is US Congress poised to hinder biosimilars market entry?)


Biotech firms would get extended patent protection in Eshoo's measure. BIO SmartBrief. 2009 December.

Michael Hiltzik. Biotech bonanza lurks in healthcare reform bills. A proposal by Rep. Anna Eshoo would give developers of innovative biomedical drugs 12 years of statutory protection from generic competition, significantly extending their patent rights. Los Angeles Times. 2009 December 17.

Source: BIO SmartBrief; Los Angeles Times

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