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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...

Prestige Biologics, a contract development and manufacturing organization (CDMO), announced it has signed a non-binding MOU with Aurigene Pharmaceutical Services, a wholly-owned subsidiary of Dr Reddy’s Laboratories.  The Korea Economic Daily reported that Prestige Bi...

Meitheal Pharmaceuticals announced an exclusive licensing agreement with Tonghua Dongbao Pharmaceutical to commercialise three insulin biosimilars (insulin aspart, insulin lispro and insulin glargine) in the US. Under the agreement, Meitheal’s parent company Nanjing King-Fr...

Abbott announced it has entered into a commercialisation agreement with mAbxience for several biosimilars focusing on oncology, women’s health and respiratory diseases in emerging markets in Latin America, Southeast Asia, the Middle East and Africa.  The first molecul...

Biocon Biologics announced that Yesafili®, its biosimilar to Regeneron’s Eylea® (aflibercept), has received marketing approval from the European Commission (EC).  It was approved to treat various ophthalmic conditions such neovascular (wet AMD) age-related macular degenerat...

On 20 September, Alvotech announced that the FDA has accepted its resubmitted Biologics License Application (BLA) for AVT02, a high-concentration, interchangeable biosimilar to AbbVie’s Humira® (adalimumab).  The BsUFA goal date for the resubmitted BLA is 24 February 2024. ...