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On 25 April 2024, Biogen announced that its Tofidence™ (tocilizumab), biosimilar to Roche’s RoActemra®, received a positive opinion from EMA’s Committee for Medicinal Products for Human Use (CHMP).  The recommendation relates to the IV formulation of tocilizumab for t...

On 25 April 2024, EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for Amgen’s Wezenla™ (ustekinumab), biosimilar to Janssen’s Stelara®.   Wezenla™ is proposed to be available in a 45 mg and 90 mg solution for injectio...

On 25 April 2024, Evernorth, a provider of health services and member of the Cigna Group, announced that it will offer biosimilar adalimumab to US patients with no patient out-of-pocket costs from June 2024, resulting in savings to the patient of around US $3,500 per year ....

On 24 April 2024, the FDA released an updated draft guidance document  on the marketing of prescription biological reference products, biosimilar products, and interchangeable biosimilar products  seeking input from industry by 25 June 2024.
The revised guidance large...

On 24 April 2024, Alvotech announced positive topline results from a confirmatory clinical study of AVT05 (golimumab), with the biosimilar demonstrating therapeutic equivalence to Janssen’s Simponi® and Simponi Aria® in patients with moderate to severe rheumatoid arthritis....

On 24 April 2024, IAM reported that information on the first biosimilar disputes in the Unified Patents Court (UPC) has become publicly available.
The first of these disputes were filed by Alexion on 19 March 2024 at the Hamburg Local Division of the UPC against each ...

Samsung Biologics revealed in its Q1 2024 Earnings that its subsidiary Samsung Bioepis has experienced year over year revenue growth of 31% and year over year operating profit of 6%, driven by sales expansion of its newly launched products.
Biosimilar highlights for Q...

On 22 April 2024, Samsung Bioepis announced that the European Commission granted marketing authorisation for its Pyzchiva®, biosimilar to Janssen’s Stelara® (ustekinumab).  The approval comes two months after the CHMP adopted a positive opinion for Pyzchiva® for the treatme...