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Samsung announces FDA approval of adalimumab biosimilar, Hadlima® for RA, JIA, PSA, Crohn’s, UC, PP and AS.  This is Samsung’s third biosimilar anti-TNF Ab approval in the US.  It will be marketed by Merck in the US, after 30 June 2023 pursuant to the terms of S...

Pfizer announces FDA approval for rituximab biosimilar rituximab (Ruxience®) for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis. This is the second biosimilar RmA...

Sandoz announces commencement of patient enrolment in Ph I/III trials of proposed biosimilar denosumab. A total of 520 osteoporosis patients will be enrolled in the 52 week study.

Amgen files new patent infringement suit against Tanvex. Amgen’s complaint alleges that Tanvex did not provide certain manufacturing information required by BPCIA legislation.

Samsung announces that its application for BmAb candidate SB8 has been accepted for review by the EMA.

Both Amgen and Celltrion’s biosimilar trastuzumab products, Kanjiti® and Herzuma® respectively, were considered by Australia’s PBAC committee for PBS listing and A flagging (substitution).  This follows the May 2019 PBAC recommendations for PBS listing of Mylan ...

Amgen launches Mvasi® in the US. Mvasi is approved for five types of cancer and was the first oncology therapeutic biosimilar approved by the FDA.

Celltrion announces creation of JVCo with Nan Fung Group for the commercialisation of Remsima®, Truxima® and Herzuma® in China. The joint venture company, Vcell Healthcare will obtain exclusive rights to develop, manufacture and commercialise these three products in mainlan...

US District Court refuses Genentech’s request for a temporary restraining order and preliminary injunction against Amgen following Amgen’s launch of biosimilar trastuzumab Kanjinti®. In a memorandum opinion the Court has called Genentech’s request ‘c...

Revocation proceedings were commenced in the Federal Court by Samsung Bioepis on a Fresenius Kabi adalimumab formulation and use patent AU2015263246 (‘246).  The 246 patent covers a specific formulation of adalimumab with a histidine buffer, sugar, surfactant and pH, and us...