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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...

Alvotech announces completion of enrolment in Phase III trials of biosimilar adalimumab AVT02.  407 participants across Europe have enrolled, while Phase I PK trials are ongoing.

Celltrion announces start of Phase I Clinical trials of omalizumab biosimilar, with Phase III trials expected to begin in the first half of 2020.

We previously reported that Samsung Bioepis commenced proceedings in July 2019 in the AU Federal Court seeking to revoke an adalimumab formulation and use patent owned by Fresenius Kabi.  In an interesting development, Fresenius Kabi surrendered the patent in the patent off...

Study finds mAbxienxe’s biosimilar rituximab candidate RTXM83 is not inferior to the reference drug in terms of efficacy.

Mylan launches Hulio® in Spain following EC approval in September 2018.

Catalyst Biosciences announce eptacog alfa biosimilar met primary endpoints in Ph II trials.