The Senate Health, Education, Labor and Pensions Committee today approved a bill that would give the Food and Drug Administration power to approve generic versions of complex biotech drugs.

Biotech drugs, or “biologics” — products made from biological substances obtained from living organisms — are often used like traditional pharmaceuticals. Examples include insulin for diabetes treatment, many hormones and the anemia drug Epogen.

Chairman Edward M. Kennedy, D-Mass., and ranking GOP member Michael B. Enzi of Wyoming defeated several amendments from both sides, preserving what they described as a delicate compromise on the legislation (S 1695), which was approved by voice vote.

Under the bill, developers of biotech drugs would get 12 years of market exclusivity for new drugs, after which generic follow-ons could enter the market. The first generic to be approved would get one year of exclusivity.

If it becomes law, the legislation is expected to do for biotech drugs what a 1984 law did for traditional drugs, paving the way for cheaper generic versions that save money for consumers and taxpayers.

The FDA would have to determine that a biosimilar drug was safe and effective and presented no greater risk than the original product. The biosimilar drug also would have to be interchangeable, meaning a patient could switch from the brand name to the biosimilar drug with no clinical difference.