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On 26 April 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes of the applications for reimbursement considered at its March 2024 meeting.
The following biosimilars have been recommended for listing on the Pharmaceutical Benef...

On 29 April 2024, Intas subsidiary Accord BioPharma announced that the FDA has approved Hercessi™, biosimilar to Roche’s Herceptin® (trastuzumab), for the treatment of HER2-overexpressing breast and gastric / gastroesophageal junction adenocarcinoma.  This is the first US b...

On 29 April 2024, each of Amgen and Sandoz announced that they resolved the US patent litigation regarding Sandoz’s denosumab biosimilars enabling Sandoz to launch Jubbonti® and Wyost® from 31 May 2025, or earlier in certain (undisclosed) circumstances.
This concludes...

A paper published in the Journal of the American Academy of Dermatology on 27 April 2024 reported that, in a Phase 3 clinical trial sponsored by Samsung Bioepis, SB17 (ustekinumab) was biosimilar to Janssen’s Stelara® (in terms of efficacy, safety, pharmacokinetics, and imm...

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On 24 April 2024, the FDA released an updated draft guidance document  on the marketing of prescription biological reference products, biosimilar products, and interchangeable biosimilar products  seeking input from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 ...