On 5 May 2025, Alvotech and Teva announced that the US FDA has approved Selarsdi® (ustekinumab-aekn) as interchangeable with J&J’s Stelara® (ustekinumab) in all presentations…
On 1 May 2025, Business Korea reported that, on 28 April 2025, Samsung Bioepis defeated Johnson & Johnson (J&J) and Janssen Biotech’s application for a preliminary injunction preventing US sales of…
On 30 April 2025, Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending an update to the European Union (EU) label for Phesgo®…
On 30 April 2025, when announcing its Q1/2025 financial results, Sandoz indicated that it will be “minimising” the Phase 3 trial of its biosimilar to MSD’s Keytruda® (pembrolizumab) in patients with…
On 30 April 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved a subcutaneous (SC) formulation of BMS’ Opdivo® (nivolumab). The SC formulation of nivolumab…
On 29 April 2025, Sandoz and Shanghai Henlius Biotech announced that they have entered into a global collaboration agreement to commercialise a biosimilar of BMS’ Yervoy® (ipilimumab)…
At its April meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Aurobindo Pharma’s subsidiary CuraTeQ’s Dazublys®…
On 25 April 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing approval for eight denosumab biosimilars…
On 24 April 2025, Samsung Bioepis published its ninth quarterly US Biosimilar Market Report, which has been released every quarter since April 2023. The report details average sales price (ASP) and…
On 24 April 2024, Halozyme Therapeutics announced that it has sued MSD for patent infringement in the US District Court for the District of New Jersey…
On 24 April 2025, the outcomes of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) March 2025 meeting were published, including recommendations for the listing of three biosimilars…
The UK’s National Institute for Health and Care Excellence has recommended NHS funding for Bristol Myers Squibb’s immunotherapy combination Opdivo® (nivolumab) and Yervoy® (ipilimumab) as a…
On 18 April 2025, Sanofi and Regeneron announced that Dupixent (dupilumab) received FDA approval as the first new targeted therapy in over a decade for chronic spontaneous urticaria (CSU)…
On 18 April 2025, Regeneron announced that it received a complete response letter (CRL) from the US FDA regarding the supplemental Biologics Licence Application (sBLA) for Eylea HD® (aflibercept…
On 25 April 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing approval for eight denosumab biosimilars…On 16 April 2025, EmblemHealth, a US nonprofit health insurer, filed a class action complaint in the US District Court for the District of Massachusetts alleging that AstraZeneca subsidiary, Alexion…
On 16 April 2025, Shanghai-based CDMO, Chime Biologics, announced that it has entered a strategic cooperation agreement with Polpharma Biologics “to advance the end-to-end development and…