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Significant biosimilar activities this week include:

08 Oct 22 | US | Samsung to pursue adalimumab interchangeability in the US

In an interview with Managed Healthcare, Samsung Bioepis’ head of US market access Tom Newcomer announced that Samsung Bioepis will ...

Janssen published data from its Ph IIa clinical trials of guselkumab with golimumab in the treatment of ulcerative colitis.  Janssen reported that adults with moderately to severely active ulcerative colitis (UC) who received 12 weeks of combination induction therapy with g...

India’s Central Drug Standard Control Organisation granted permission to IQVIA to conduct Ph III clinical trials of Alvotech’s AVT06 (biosimilar aflibercept) for the treatment of retinal vascular diseases.

In an interview with Managed Healthcare, Samsung Bioepis’ head of US market access Tom Newcomer announced that Samsung Bioepis will pursue interchangeability for Hadlima® (biosimilar adalimumab) in 2024.  Hadlima was approved in the US in July 2019 and is expected to launch...

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.