Humira biosimilars unlikely to launch before Amgen’s Amjevita or by 2018 - legal experts

09 Dec 2016

The numerous biosimilars for AbbVie’s (NYSE:ABBV) Humira (adalimumab) are unlikely to reach the market prior to Amgen’s (NASDAQ:AMGN) approved biosimilar, Amjevita, and certainly not before 2020, legal experts agreed. AbbVie’s patent estate for Humira is far too complex and Amgen has enough of a head start advantage with its approval and ongoing litigation that it is not likely another biosimilar could surpass it to market, they said.

Further, legal experts agreed it is more likely a Humira biosimilar would reach the market in 2022.

Analysts have said despite Amgen’s biosimilar being the first to receive approval, Coherus Biosciences’ (NASDAQ:CHRS) biosimilar, CHS-1420, could be the first to hit the market and as soon as 2018 based on its formulation and dosing infringing less on AbbVie’s patent estate than other challengers.

However, legal experts this news service spoke to said, Coherus and other manufacturers will have to face the same legal battle as Amgen and even a formulation advantage would not be sufficient for an earlier launch.

On 23 September, the FDA approved Amjevita as the first Humira biosimilar for the same indications as the originator. Humira was approved by the FDA in 2002.

Coherus announced positive top-line Phase III results with CHS-1420 on 8 August, following results from four prior successful Phase IIIs. The company said it plans to file a BLA in 2H16 and launch in 2018, according to the 8 August press release.

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