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A Phase III study funded by Celltrion compared the efficacy and safety of its ustekinumab biosimilar CT-P43 to Janssen’s Stelara® (ustekinumab).  The study concluded that CT-P43 was equivalent in efficacy in treating patients with moderate to severe plaque psoriasis, and ha...

Sandoz has launched its high concentration formulation (100mg/ml) of Hyrimoz® in Europe, biosimilar to AbbVie’s Humira® (adalimumab).  This citrate-free high concentration formulation is indicated for all conditions for which Humira® is supplied.

Hyrimoz® was granted...

BeiGene and Ensem Therapeutics announced that BeiGene will acquire Ensem’s investigational new drug (IND) application-ready oral cyclin-dependent kinase 2 (CDK2) inhibitor as part of an exclusive global licensing deal.  Ensem will receive an upfront payment and is eligible ...

Regeneron filed a Complaint in the US District Court for the Northern District of West Virginia against Samsung Bioepis asserting infringement of 37 US aflibercept patents.  The heavily redacted Complaint does not disclose any information about Samsung’s abbreviated Biologi...

On 21 November 2023, the Canadian Federal Court of Appeals dismissed Janssen’s appeal from a decision of the Federal Court upholding Canada’s Office of Submission and Intellectual Property (OSIP) refusal of Janssen’s application to list Canadian Patent 3113837 on the PMNOC ...

Biocon Biologics filed an Inter Partes Review (IPR) petition against  certain claims of Regeneron’s US patent no. 10,888,601 relating to Eylea® (aflibercept).  The challenged claims relate to methods of treating diabetic macular edema and diabetic retinopathy.  Biocon Biolo...

AbbVie commenced proceedings in the US District Court of Delaware against Sandoz, Hetero Labs, Aurobindo Pharma, Intas Pharmaceuticals, Accord Healthcare and Sun Pharma, alleging infringement of 34 Rinvoq® (upadacitinib) patents, including compound, process and method of tr...

Sam Chun Dang Pharmaceutical announced in a corporate filing that it has signed an exclusive 10-year distribution agreement with an unnamed distributor regarding SCD411, biosimilar to Regeneron’s Eylea® (aflibercept), to be supplied to Austria, Germany, Italy, Spain and Swi...