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FDA Staff Backs Etanercept (Enbrel) Biosimilar

Amgen files suit to block GP2015

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:

  • To reduce signs and symptoms, induce a major clinical response, inhibit the progression of structural damage, and improve physical function in patients with moderately to severely active rheumatoid arthritis in combination with methotrexate (MTX) or used alone
  • To reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients 2 years of age or older
  • To reduce signs and symptoms, inhibit the progression of structural damage of active arthritis, and improve physical function in patients with psoriatic arthritis in combination with MTX in patients who do not respond adequately to MTX alone
  • To reduce signs and symptoms in patients with active ankylosing spondylitis
  • To treat adult patients (18 years or age or older) with chronic moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy

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.

Sources: Reuters; July 11, 2016; and FDA Briefing Document; July 11, 2016.

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