Is US Congress poised to hinder biosimilars market entry?

Biosimilars/General | Posted 19/01/2010 post-comment0 Post your comment

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. Ms Eshoo said her proposal would give original makers of biotech drugs adequate profit to discover new treatments without discouraging generic drugmakers from working on follow-on biologics.


The debate over healthcare reform is focused on such a small number of hot issues (e.g. should there be a public option, Medicare buy-in, government-paid mental health counselling for Senator Lieberman?) that dozens of other questions are cruising under the radar.

According to Mr Hiltzik, there is one worth a lot more attention than it has been getting: Is US Congress poised to make a big pay-off to biotech firms and their venture backers by hindering the entry of a new class of generic drugs into the marketplace? That is the rap on an amendment sponsored in the US House reform bill by Ms Eshoo, whose Palo Alto district in California is home to bands of venture capitalists. (Matching language is in the Senate bill.)

He explains that Ms Eshoo’s provision would give developers of innovative biomedical drugs 12 years of statutory protection from generic competition, significantly extending their patent rights. That is a lot longer than the five-year head start that federal law gives to conventional pharmaceuticals. Introduced in 1984 as part of the Hatch-Waxman Act, the five-year standard has proved effective enough to create what is now an annual US$60-billion generics market in the US alone. This saves American consumers roughly US$10 billion a year, manufacturers say. The rule extends a drug's patent protection beyond the usual 20 years to make up for the lengthy government approval process; to illustrate, if your drug does not win approval from the FDA until 17 years after you patent it, you can market it, untouched by generics, for five years after approval. If you tweak the drug formula slightly to make it work better, you get three more years of exclusivity. In certain cases Ms Eshoo's measure would afford those tweaks an extra 12 years, on top of the original 12. That is a process condemned by the generics industry as ‘evergreening’, which may be the first time that the stately evergreen has been co-opted for a curse word. Ms Eshoo says her measure will give manufacturers of innovative biological drugs such as interferon and some advanced cancer drugs enough potential profit to keep them hunting for new products without discouraging generics makers from developing cut-rate versions. "It's a delicate balance", she said. She argued that without her measure there would not be a generics industry in biologicals at all, because her bill is the first to establish a federal regulatory programme in the field; biologicals are not subject to Hatch-Waxman.(see also US regulators should catch up with Biosimilars Pathway and Considerations about the exclusivity period of biologicals)


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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