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The EMA accepts Celltrion’s application for a subcut formulation of biosimilar infliximab, Remsima SC®.

At the ASH Annual meeting, a paper was presented indicating positive results for Sandoz’s proposed RmAb biosimilar to EU reference drug, and concluding “efficacy, safety and immunogenicity, PK and PD of PF‑05280586 and rituximab-EU were similar up to Week 26 in ...

AbbVie announces a 7th global deal for biosimilar adalimumab. A non-exclusive royalty bearing license to Pfizer for AmAb will begin on 20 November 2023 in the US and on approval in the EU (no other dates disclosed).  Pfizer’s US launch date is the same as Momenta̵...

Tanvex announces that the FDA has accepted its BLA for biosimilar filgrastim.

FDA approves Celltrion’s rituximab biosimilar CTP-10 (Truxima®), for the treatment of non-Hodgkin’s lymphoma. This is the first US biosimilar RmAb to be approved.

Daiichi Sankyo launches first trastuzumab biosimilar in Japan.

Sandoz announces EC marketing approval for pegfilgrastim biosimilar Ziextenzo®.

EMA approves biosimilar pegfilgrastim Pelmeg® for patients undergoing cytotoxic chemotherapy for malignancy, with the exceptions of chronic myeloid leukaemia and myelodysplastic syndromes.

Fuji Pharma and Alvotech announce exclusive partnership agreement for the commercialisation of Alvotech’s biosimilars in Japan. Fuji Pharma will be responsible for the registration and commercialisation of products, while Alvotech will be responsible for development a...

Sandoz receives approval for rituximab biosimilar under two presentations and two brands. The approval includes 500mg/50mL Rixonfya®, 100mg/10 mL Rixonfya®, 500mg/50mL Rixvyda® and 100mg/10mL Rixvyda®. Sandoz is currently prevented from supplying for use, selling, supplying...