A biosimilar version of the blockbuster arthritis drug etanercept (Enbrel, Amgen) is highly similar to the original in terms of safety, purity, and potency, according to FDA staff scientists. Their comments come two days ahead of a meeting of the FDA’s Arthritis Advisory Committee, which will discuss the drug and recommend whether it should be approved.
Etanercept is an injected biologic drug made from living cells. Biologics are more complex than traditional pills and cannot be copied with precision. Copies are therefore called biosimilars, not generics.
Sandoz has submitted a biologics license application (BLA) for GP2015, a proposed biosimilar to etanercept. A BLA for Enbrel was initially licensed to Amgen in 1998. Sandoz is seeking the following indications:
GP2015 was developed as a solution for injection in a prefilled syringe or autoinjector with strengths, dosage forms, and routes of administration (25 mg/0.5 mL or 50 mg/1.0 mL) previously approved for Enbrel. The GP2015 formulation differs from that of Enbrel. The GP2015 formulation includes a citrate buffer, whereas the Enbrel formulation includes a phosphate buffer.
According to Reuters, it could be some time before GP2015 reaches the U.S. market even if it is approved. Amgen has filed suit against Sandoz, claiming the company is “piggybacking on the fruits” of Amgen’s research efforts.