Here Come the Bio Similar Drugs – Bill in Congress to allow Follow Me Provisions for the FDA

If you thought competition was tough with generic drugs, there’s a new kid on the street, biosimilar drugs. The link below goes to a page on the Genentech website that explains the process in full detail.

“The terms "Biosimilar" or "Follow-on Biologic" refer to products that are marketed after expiration of patents, which are claimed to have similar properties to existing biologic products. Due to the complexity of biologics, a product can only be made that is similar, but not identical.”

Merck and Teva are 2 companies with a vested and growing interest in the follow on market. Related reading has more below. BD

Reps. Henry A. Waxman, Frank Pallone, Nathan Deal, and Jo Ann Emerson introduced H.R. 1427, the “Promoting Innovation and Access to Life-Saving Medicine Act,” a bipartisan bill to allow the Food and Drug Administration to approve affordable copies of biotech drugs. Biotech drugs, while often life-saving, are the fastest growing and most expensive components of the nation’s prescription drug bill. Many of them cost tens of thousands of dollars a year — prices that put them out of reach of patients and impose an unsustainable burden on employers, insurers, and the federal government.

FDA currently lacks clear authority to approve generic versions of these products, allowing companies to charge monopoly prices even after all patents have expired. Introducing fair competition for biotech drugs is essential to keep these life-saving treatments affordable. Today’s bill gives FDA authority to ensure that any approved copy of a biotech drug is just as safe and effective as the original product, and provides the makers of new biotech drugs ample incentives for continued innovation. The Promoting Innovation and Access to Life-Saving Medicine Act is consistent with the legislation described in the President’s proposed budget.

Generic and brand name companies alike are now planting their seeds in the emerging follow-on biologic market and Congress should make every effort to support these efforts with the best interest of patients in mind. This sensible, consumer-focused legislation represents a dramatic first step in passing legislation to establish an approval and regulatory pathway for biologic products and I am pleased to join Chairman Waxman and Chairman Pallone in co-sponsoring the Promoting Innovation and Access to Life-Saving Medicine Act.”