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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...

China’s National Medical Products Administration accepts Innovent’s application for biosimilar adalimumab. The application seeks approval for the treatment of ankylosing spondylitis, rheumatoid arthritis, and psoriasis.

Coherus discloses newly approved biosimilar Udencya® will be available at a 33% discount to Neulasta®, matching the price point for Mylan’s biosimilar Fulphila®. The product is due to be launched on 3 January 2019.

Biogen and Samsung Bioepis close asset transfer to increase Biogen’s share in Samsung Bioepis to 49.9%. This deal originates from the initial creation of Samsung Bioepis and the partnership between Biogen and Samsung BioLogics, in which Biogen was granted an option to...