FDA approves adalimumab biosimilar amid ongoing patent litigation

Tuesday, 27 Sep 2016

A patent infringement lawsuit looks set to delay the launch of the fourth biosimilar to be approved in the US.

Late last week the FDA approved Amgen’s biosimilar of Abbvie’s adalimumab (Humira) called ‘Amjevit’.

In a statement the regulatory authority said the approval was based on a review of evidence including “structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Amjevita is biosimilar to Humira”.

As with the other three biosimilars currently approved in the US, Amjevit is approved as a biosimilar and not as an “interchangeable product”, meaning it cannot be substituted for its reference product at the pharmacy level.

The biosimilar is approved for the following indications in adult patients:

  • moderately to severely active rheumatoid arthritis;
  • active psoriatic arthritis;
  • active ankylosing spondylitis (an arthritis that affects the spine);
  • moderately to severely active Crohn’s disease;
  • moderately to severely active ulcerative colitis; and
  • moderate to severe plaque psoriasis.

It is also indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years of age and older. It will carry a similar boxed warning as Humira about an increased risk of serious infections leading to hospitalisation or death.

However, its launch looks set to be delayed following the filing of a patent infringement lawsuit last month by AbbVie that alleged Amgen had violated AbbVie’s patents.

In other news, the FDA also announced this week three extended indications for canakinumab (Ilaris): tumour necrosis factor receptor-associated periodic syndrome (TRAPS); hyperimmunoglobulin D syndrome, also known as mevalonate kinase deficiency; and familial Mediterranean fever.

Canakinumab was previously approved for cryopyrin-associated period syndrome and for systemic juvenile idiopathic arthritis.

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