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India’s DCGI granted marketing authorisation for Enzene Bioscience’s biosimilar denosumab.

Bio-Thera Solutions and Hikma Pharmaceuticals announced that they have signed an exclusive commercialisation and license agreement for BAT2206 (proposed ustekinumab biosimilar). Under the agreement, Hikma will gain exclusive commercialisation rights in the US with a first-r...

Two former executives of JHL Biotech plead guilty to conspiracy to steal trade secrets and commit wire fraud exceeding $101 million in the US District Court for the Northern District of California. The written plea agreements disclosed that the executives used confidential,...

The US District Court for the Northern District of Illinois refused to dismiss AbbVie’s Humira® (adalimumab) infringement suit against Alvotech hf. The court found that AbbVie is not required to sue the US based subsidiary listed on the aBLA form, but could sue Icelandic co...

NZ’s Pharmac announced that it is considering awarding Principal Supply to Amgevita® (biosimilar adalimumab). Pharmac is seeking feedback on the proposed changes to the funding arrangements.

The US Federal Circuit reversed an infringement judgement against Kite Pharma (part of Gilead Pharma) of a patent relating to CAR-T therapies on the basis of lack of written description.  The Sloan Kettering Institute for Cancer Research owned patent at issue was licenced e...

Cipla and Kemwell Biopharma announced that they have executed a joint venture agreement to develop, manufacture and commercialise biosimilars, with an aim to enter the respiratory biosimilars space.

UCB announced that it has gained EU marketing approval for Bimzelx® (bimekizumab), an IL-17A and IL-17F inhibitor indicated for the treatment of adults with moderate to severe plaque psoriasis.

The UK’s MHRA granted conditional marketing authorisation for REGEN-COV®/Ronapreve® (casirivimab and imdevimab antibody cocktail) to prevent and treat acute COVID-19 infection.