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AbbVie announces a global settlement with Mylan under which Mylan acknowledges Humira® AbbVie’s patents are valid, and Mylan receives a royalty-bearing, non-exclusive global license (excluding Europe) from 31 July 2023.  This date will not be accelerated by entry of A...

Celltrion obtains approval for its biosimilar TmAb products in Australia (150mg products branded as Simabtra®, Herzuma®, and Hertuzu®).  These are the first biosimilar TmAb products to be approved in AU.

Xbrane and STADA announce they have entered into an agreement to develop a ranibizumab biosimilar for US, EU and other markets.  Under the agreement, Xbrane will be responsible for developing the product while STADA will be responsible for the marketing authorisations and s...

Biocon receives EU CGMP certification for its facility in Bangalore, clearing the way for the approval of pegfilgrastim and trastuzumab biosimilars.

Prestige and Alvogen announce partnership to commercialise Prestige’s trastuzumab biosimilar, Hervelous®, in Central and Eastern Europe.

Lupin and Mylan announce agreement to commercialise etanercept biosimilar in Europe, Australia, New Zealand, Latin America, Africa and Asia.

Amgen releases results of Phase III study of infliximab biosimilar, revealing no clinically meaningful differences to Remicade®.

Celltrion launches infliximab biosimilar in Libya and Tunisia. The product will be distributed through Celltrion’s local partner Hikma Pharmaceuticals and is part of Celltrion’s overall plan to expand sales networks across Africa and into the Middle East.

US Senators Chuck Grassley and Amy Klobuchar urge FTC to investigate ‘pay-for delay’ settlements, in particular AbbVie’s Humira settlements, for anti-competitive behaviour.  Of particular concern is investigating whether these settlements are keeping biosi...

Celltrion resubmits application for marketing approval of trastuzumab biosimilar to the FDA. This follows CRLs from the FDA related to the February warning letter regarding Celltrion’s manufacturing facility in South Korea.