Everybody knows Congress is likely to create a pathway for generic versions of biotech drugs to come to market. The fight now is over the details.
A bipartisan group of senators today introduced a bill that would grant branded biotech drugs five years of exclusivity, Dow Jones Newswires reports. The legislation parallels a bill championed by Henry Waxman, the powerful House Dem.The branded drug industry has been pushing for 14 years of exclusivity. The longer period has gathered some congressional support in the past, but the five-year camp has a fair bit of juice behind it now.
As the WSJ noted a few weeks ago, the Waxman bill is co-sponsored by Nathan Deal of Georgia, a House Republican and a conservative who previously questioned the legislation. The Senate bill was introduced today by New York Dem Chuck Schumer and Susan Collins (pictured), the Maine Republican who has been a key figure in the Senate this year.
Meanwhile, drug companies have decided to join those who they can’t beat. Merck said last year that it was getting into the generic biotech business, and Novartis is already selling generic biotech drugs in Europe. AstraZeneca’s CEO recently expressed interested in getting into the segment as well.
By MATTHEW PERRONE – 22 hours ago
Some excerpts:
Biotech drugs were not included in the 1984 law that first allowed the FDA to approve copies of traditional, chemical drugs. At the time the biotech industry successfully argued that their drugs, which are made from living cells, were too complex to be duplicated by generic competitors.
A Senate aide said Thursday that Kennedy would not endorse the five-year approach. Instead the 77-year-old Democrat — whose home state is a biotech stronghold — plans to seek 12 years of market exclusivity.
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