Drug industry applauds FDA plans for biosimilar review

The drug industry says it's pleased with the Food and Drug Administration's early plans for reviewing generic versions of complicated biologic drugs.

The healthcare reform law for the first time created an approval pathway for so-called "biosimilars." The regulatory agency on Monday announced that it will hold a public meeting with stakeholders on Dec. 16 to chart a way forward for a user fee program that would help pay for the FDA's review of biosimilar applications.

The announcement includes calls for the creation of a special protocol assessment mechanism for clinical trials, which the Pharmaceutical Research and Manufacturers of America says will "help to ensure that clinical trials are designed to thoroughly assess the safety and efficacy of biosimilar medicines, in accordance with the FDA’s high regulatory and scientific standards."