Firms Forge Ahead on Follow-On Biologics

Although the FDA has made little headway on developing a formal approval pathway for follow-on biologics, drug developers aren't sitting on their hands waiting for the agency to act.

Two companies taking a more proactive approach on the issue are generic drugmaker Three Rivers Pharmaceuticals and biopharmaceutical distributor Aceto. The firms recently signed an agreement that calls for the development of three follow-on biologics for the domestic and international markets.

Under the terms of the agreement, Aceto will source the active pharmaceutical ingredients, manage the regulatory and quality control functions of production, and supply the final dosage form of the follow-on biologics to Three Rivers. In turn, Three Rivers will file applications with the necessary regulatory agencies to market the follow-on biologics, also referred to as generic biologics, in the U.S., Europe and Japan.

Three Rivers plans to submit its applications to the FDA and international regulators within the next year and expects to have the products on the market by 2007. The companies are not releasing the names of the products at this point for competitive reasons.