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Sandoz announced its new Act4Biosmilars Action Plan as part of its Act4Biosimilars initiative that aims to increase the adoption of biosimilars in over 30 countries by 30% by 2030.  The Plan features 12 initiatives to help accelerate biosimilar uptake, examining accessibili...

Coherus has confirmed in a Form 8-K filed with the SEC that it has resolved its recent dispute with AbbVie relating to a potential breach of its settlement and licence agreement entered into in late 2019, under which Coherus received a royalty bearing non-exclusive licence ...

Seagen’s SEC filing has disclosed that Pfizer withdrew its notification to the Federal Trade Commission (FTC) and Department of Justice (DOJ) to acquire Seagen for US$43B.  The filing also notes that the companies expect to complete the acquisition in late 2023 or early 202...

The Korea Economic Daily reports that Celltrion announced it intends to apply for regulatory approval of five new biosimilars before the end of 2023. Celltrion intends to offer more than 10 biosimilars by 2025, of which it currently offers six.  Celltrion also confirmed tha...

AstraZeneca announced that the Chinese NMPA has approved Soliris® (eculizumab) for treatment of refractory generalised myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. This is the third approved indication approved for Soliris®...

Alvotech and Teva announced they have reached a settlement and license agreement with Johnson & Johnson for AVT04, Alvotech’s biosimilar to Stelara® (ustekinumab).  J&J have granted a license entry date for AVT04 in the US no later than 21 February 2025. This is sev...

Biogen announced that the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) unanimously voted that the results of a specific Eisai phase III clinical trial verified the clinical benefit of LEQEMBI® (lecanemab) for the treatment of Alzheimer’s...

JAMA Ophthalmology published the results of Ph III trials of Samsung Bioepis’ SB15 (aflibercept biosimilar).  Researchers reported that SB15 showed equivalent efficacy and comparable safety, pharmacokinetics and immunogenicity to reference aflibercept in participants with n...

Samsung Biologics and Pfizer announced that they have entered a new long-term strategic partnership for manufacturing of Pfizer’s biosimilars portfolio.  According to a Samsung Biologics company filing, the contract is worth US$411M.  Using its newest facility, Plant 4, Sam...