Court Battle Will Delay Launch of Enbrel Biosimilar Until at Least 2018

Amgen claims patent protection

Novartis’ head of generics has told the Reuters news service that the company’s biosimilar copy of Amgen’s psoriasis drug Enbrel (etanercept) will not go on sale in the United States before 2018 at the earliest because of a patent-protection challenge from Amgen.

Even though the FDA has approved the biosimilar version, called Erelzi, for the treatment of patients with rheumatoid arthritis (RA), plaque psoriasis, ankylosing spondylitis (AS), and other diseases, Amgen is arguing in U.S. federal court that its drug has patent protection until 2029.

Novartis said it will be at least another year before the legal hassle is resolved.

Novartis and Amgen are also embroiled in a separate legal battle over how quickly companies can begin sales of biosimilar copies, Reuters reported. The U.S. Supreme Court has agreed to hear that case, which hinges on whether companies must wait six months after FDA approval before they can begin selling their biosimilar versions.

The FDA approved Erelzi in August 2016 for the following indications:

  • Moderate-to-severe RA, either as a stand-alone therapy or in combination with methotrexate (MTX)
  • Moderate-to-severe polyarticular juvenile idiopathic arthritis in patients 2 years of age and older
  • Active psoriatic arthritis, including use in combination with MTX in patients with psoriatic arthritis who do not respond adequately to MTX alone
  • Active AS
  • Chronic moderate-to-severe plaque psoriasis in adult patients (18 years of age or older) who are candidates for systemic therapy or phototherapy

Biologic products are generally derived from a living organism and can come from many sources, including humans, animals, microorganisms, and yeast. A biosimilar is a biologic product that is approved based on evidence that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety and efficacy compared with the reference product, in addition to meeting other criteria specified by law.

Etanercept was originally licensed in 1998.

Sources: Reuters; January 25, 2017; and FDA; August 30, 2016.