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Celltrion announced the commencement of Ph III clinical trials regarding Yuflyma® (biosimilar adalimumab) in Estonia.  This trial will run for 13 months and will be used to support Celltrion’s application for interchangeability in the US.  Yuflyma was approved in the EU in ...

Significant biosimilar activities this week include:

30 Sep 22 | EU | EMA accepts Biogen tocilizumab MAA

Biogen announced that the EMA has accepted the MAA for BIIB800 (biosimilar tocilizumab).  Biogen holds the rights to commercialise Bio-Thera’s product in a...

A temporary increase in medicare payments for qualifying biosimilars commenced under section 11403 of the Inflation Reduction Act.  This temporary increase applies to biosimilars whose average sales price is not more than the price of the reference product. This provision i...

Amneal Pharmaceuticals announced the launch of Alymsys® (biosimilar bevacizumab) in the US on 03 October 2022. Alymsys was developed by mAbxience and was approved by the FDA in April 2022.

The FDA announced that it will pilot a regulatory science program to advance the development of interchangeable products and improve the efficiency of biosimilar product development.  The program, set out briefly in the FDA’s Biosimilar User Fee Act (BsUFA) reauthorization ...

Biogen announced that the EMA has accepted the MAA for BIIB800 (biosimilar tocilizumab).  Biogen holds the rights to commercialise Bio-Thera’s product in all countries excluding China under an April 2021 agreement.