A US Senate Committee has approved an amendment to protect manufacturers of biotechnology drug products from generic competition for 12 years.
A 16-7 vote in the Senate Health, Education, Labor and Pensions Committee approved the amendment to award the biotechnology industry with 12 years of exclusivity before generics can be launched.
Biotech medicines, or biologics, are manufactured from living cells. Despite being more complicated and expensive to produce than conventional drugs they represent a growing segment of the industry.
Generic drug makers backed proposals limiting the exclusivity of the period from five to seven years.
The amendment now faces Congress, where it expects a tough challenge from supporters of a shorter exclusivity period.
Major manufacturers of biotech drugs include Amylin, Teva Pharmaceuticals and Mylan.