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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. ...

Merck announced the US FDA accepted for priority review its supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA ®, Merck’s anti-PD-1 therapy, in a third cervical cancer indication.  The proposed indication is for KEYTRUDA ® in combination with ex...

BeiGene announced it has regained worldwide rights to develop, manufacture, and commercialise Tevimbra® (tislelizumab) from Novartis, following a mutual agreement between the parties to terminate their previous collaboration and licence agreement entered into in January 202...

Fresenius Kabi announced that its Tyenne® (tocilizumab), biosimilar to Roche’s Actemra® / RoActemra® has been approved by the European Commission (EC) for the treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis...