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Formycon and its commercialisation partner Fresenius Kabi announced that the EMA has accepted for review their MAA for FYB202, biosimilar to Johnson & Johnson’s Stelara® (ustekinumab).

In February 2023, Fresenius Kabi and Formycon AG announced they had reached a ...

ProciseDx announced that its Procise ADL and Procise IFX therapeutic drug monitoring tests for adalimumab (AbbVie’s Humira® and Amgen’s biosimilar Amgevita®) and infliximab (Janssen’s Remicade® and biosimilars Inflectra® (Pfizer) and Renflexis® (Organon)) have received FDA ...

Coherus Biosciences announced that the FDA issued a Complete Response Letter (CRL) for its BLA for Udenyca® OnBody™, Coherus’ on-body injector presentation of Udenyca®, biosimilar to Amgen’s Neulasta® (pegfilgrastim).  The letter relates to an ongoing review of inspection f...

Sandoz and Polpharma Biologics announced that the EC has approved Tyruko® (natalizumab), biosimilar to Biogen’s Tysabri®, as a single disease-modifying therapy (DMT) in adults with highly active Relapsing Remitting Multiple Sclerosis. This is the first EC approved biosimila...

Novartis confirmed its Sandoz generics and biosimilars business will spin-off, with trading of the new Sandoz Group AG to commence on 4 October 2023.

This follows the Novartis shareholder approval for the spin-off at its EGM on September 15 2023.   The proposed spin-...

KED Global reported that Celltrion Inc. will provide biosimilars worth ₩423.6B (US$323M) to its global sales and marketing affiliate Celltrion Healthcare Co., Celltrion’s largest supply deal.  The supplies include Yuflyma® (adalimumab, biosimilar to AbbVie’s Humira®), Remsi...

Eisai and Biogen announced that Leqembi® (lecanemab) intravenous infusion was approved in Japan for slowing progression of mild cognitive impairment and mild dementia due to Alzheimer’s disease (AD). On 21 August 2023, the Japanese Ministry of Health, Labour and Welfare com...

AbbVie announced that the EC granted conditional marketing authorisation for Tepkinly® (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Alvotech announced that Fuji Pharma, its commercialisation partner in Japan, has received marketing approval for AVT04 (ustekinumab), a biosimilar to Janssen’s Stelara®, from the Japanese Ministry of Health, Labor and Welfare.  Alvotech reported that, based on publicly avai...