Read our latest updates & insights

Regeneron has filed a complaint against Mylan in West Virginia under the BPCIA alleging infringement of twenty-four patents relating to Eylea® (aflibercept).  This follows the FDA’s acceptance for review of Mylan’s aBLA for its aflibercept biosimilar.  Regeneron recently li...

Coherus Biosciences announced that the FDA has approved Coherus’ Cimerli™, a biosimilar to Genentech’s Lucentis® (ranibizumab).  Cimerli is the third approved US biosimilar, but is the first to be approved for all five of Lucentis’ indications and to receive the interchange...

Fresenius Kabi announced that the FDA has accepted for review Fresenius’ biosimilar candidate MSB11456 to Chugai’s Actemra® (tocilizumab).  Actemra is presently the only tocilizumab product on the market in the US.

Janssen announced that the FDA has approved Stelara® (ustekinumab) for the treatment of paediatric patients aged six and over with active psoriatic arthritis (PsA).  As there were insufficient paediatric patients with PsA to conduct clinical trials, the FDA based its approv...

The Court of Appeals for the Seventh Circuit has agreed with the District Court, finding that AbbVie holding 132 US patents relating to Humira®, and settling litigation regarding the same, was not anti-competitive.  The decision rejected the appeal filed by welfare benefit ...

A third revocation proceeding was commenced by Samsung Bioepis against a Fresenius Kabi adalimumab 50 mg/mL formulation patent AU2020204269 (‘269).  The ‘269 patent covers a specific formulation of adalimumab with a specific buffer, sugar, surfactant and pH.  These proceedi...

Celltrion Healthcare has reportedly filed an IND application to the FDA for a phase III clinical trial to demonstrate the interchangeability of its Yuflyma® (adalimumab) biosimilar and AbbVie’s Humira®.  The trial will involve 366 patients with plaque psoriasis.  Following ...