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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 ...

It has been reported that a Ph III clinical trial of Qilu Pharmaceutical’s biosimilar denosumab, QL1206, showed beneficial effects in post-menopausal Chinese women with osteoporosis and high fracture risk.  After twelve months, subjects who received QL1206 showed significan...

We are proud to announce that Pearce IP and its CEO have been shortlisted for three awards at the APAC 2022 Women in Business Law Awards, with the winners to be announced on 15 September.

Pearce IP is one of 5 firms and one of only 2 national firms in the APAC region...

Biocon announced that its Q1 2022 revenue for biosimilars was up 29%.  This comes in advance of Biocon’s subsidiary Biocon Biologics’ acquisition of Viatris’ biosimilars business, expected to close later in 2022.

Alphapharm (Viatris’ Australian subsidiary) has its etanercept biosimilar, Nepexto®, on the agenda for the November PBAC meeting.  If the PBAC recommends that Nepexto is PBS-listed, it will become the third PBS-listed etanercept product after Pfizer’s Enbrel® and Arrow’s Br...