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Sarcoidosis News reported a new study demonstrates that patients with sarcoidosis can safely switch from Remicade® (infliximab) or Inflectra® (biosimilar infliximab) to Flixabi® (biosimilar infliximab) and maintain similar clinical benefits.  Infliximab is not indicated for...

Alphapharm received approval for Hulio® (biosimilar adalimumab) in Australia.  Hulio® was approved in a 20mg/0.4mL solution for pre-filled syringe, 40mg/0.8mL solution for pre-filled syringe, and 40mg/0.8mL solution for pre-filled pen.  Viatris launched Hulio® in Canada and...

Celltrion released its Q1 2020 financial results, reporting that YoY sales of Celltrion biosimilars increased by 23%.  Celltrion announced that it is planning to complete Ph III trials of biosimilar bevacizumab in the first half of 2021, and that ustekinumab, aflibercept, o...

The UK’s Medicine and Healthcare products Regulatory Agency (MHRA) finalised its ‘Guidance on the licensing of biosimilar products’, outlining the licensing requirements for biosimilars in the post-Brexit UK.  The MHRA had previously foreshadowed in its dr...

Alvotech filed a federal lawsuit against AbbVie in the US District Court of the Eastern District of Virginia, seeking to clear patent barriers relating to proposed biosimilar adalimumab, AVT02.  Alvotech alleges that AbbVie has sought to protect its product monopoly by R...

Coherus BioSciences reported its Q1 2021 financial results.  Coherus disclosed that it has commenced the rolling submission of the BLA for toripalimab and that it expects to file the BLA for CHS-201 (proposed ranibizumab biosimilar) mid-2021.

The Government of Alberta announced it has expanded its biosimilars switching program to include adalimumab for all originator indications except pediatric juvenial idiopathic arthritis. All adult patients on Humira® will be switched to Amgevita®, Hadlima®, Hulio®, Hyrimoz®...