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…
Positive CHMP Opinions for 8 Denosumab Biosimilars
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Samsung Bioepis Publishes Quarterly US Biosimilar Market Report; Steep WAC Discounts for Newly Launched Ustekinumab 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…
MSD/Merck Sued for US Patent Infringement Over SC Pembrolizumab
On 24 April 2024, Halozyme Therapeutics announced that it has sued MSD (known as Merck in the US and Canada) for patent infringement in the US District Court for the District of New Jersey…
Australia’s PBAC Recommends Reimbursement of Biosimilars to Natalizumab, Omalizumab and Ustekinumab
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…
NICE Recommends Funding of Opdivo® and Yervoy® for Colorectal Cancer
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…
New Indication Alert: FDA Approves Regeneron/Sanofi’s Dupixent (Dupilumab) for Chronic Spontaneous Urticaria
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)…
FDA Issues CRL for Extended Dosing Intervals of Regeneron’s Eylea HD®
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…
Antitrust Litigation Filed Against Alexion in US Regarding Biosimilar Competition to Soliris® (Eculizumab)
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…
Polpharma and Chime Partner to Develop Undisclosed Biosimilar
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…
Approval Alert: Petrovax Pharm’s Biosimilar Denosumab First to Receive Russian Approval
On 15 April 2025, Petrovax Pharm announced that it is launching its denosumab biosimilar (Forsedeno®) in the Russian market after the Russian Ministry of Health granted marketing…
Biocon Settles Biosimilar Aflibercept BPCIA Litigation with Regeneron; Yesafili™ US Launch H2 2026
On 15 April 2025, Biocon announced that it has entered a settlement and licence agreement with Regeneron, dismissing pending US BPCIA litigation regarding its Eylea® (aflibercept) biosimilar, Yesafili™…
Sandoz Sues Amgen in US for Anti-Competitive Conduct In Blocking Biosimilar Etanercept Launch
On 14 April 2025, Sandoz announced that it has filed an antitrust lawsuit against Amgen in the US District Court of for the Eastern District of Virginia in relation to etanercept. Sandoz’s complaint…
Celltrion Secures US Interchangeability for Biosimilar Adalimumab Yuflyma®
On 14 April, Celltrion announced that it has secured interchangeability designation in the US for its high concentration (100mg/mL) citrate free adalimumab biosimilar, Yuflyma® (adalimumab-aaty)…
CuraTeQ Biologics Completes Biosimilar Denosumab Phase I Trial
On 10 April 2025, Aurobindo subsidiary, CuraTeQ Biologics, reported its successful Phase I results for BP16, biosimilar to Amgen’s Prolia® (denosumab)…
Accord/Dong-A ST’s Biosimilar Ustekinumab Launched in UK and Ireland
On 8 April 2025, The Bio reported that Dong-A ST has launched Imuldosa®, biosimilar to J&J’s Stelara® (ustekinumab) in the UK and Ireland, following its launch in Germany in January 2025…
Hague Court of Appeal Rules Samsung Bioepis can Manufacture and Stockpile its Ustekinumab Biosimilar for Export
Samsung Bioepis has successfully defeated Janssen Biotech’s appeal in the Hague Court of Appeal in which Janssen sought to overturn an earlier ruling that Samsung Bioepis did not infringe Janssen’s…