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Glenmark releases Phase I results of biosimilar omalizumab, suggesting similarity in pharmacokinetic, pharmacodynamic, safety and immunogenicity profiles to Xolair®.

Dr Reddy’s announces biosimilar trastuzumab available in India for the treatment of HER2-positive cancers.

Teva launches first biosimilar filgrastim in South Africa at 70% of the price of Amgen’s product. This comes more than 5 years after Teva first sought regulatory approval, demonstrating the backlog of products awaiting approval from the South African Health Products R...

Pfizer announces FDA approval of Pfizer’s Nivestym®, biosimilar to filgrastim for all indications.

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.