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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® (150 mg powder for concentrate for solution for infusion), biosimilar to Roche’s Herc...

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.

Gedeon Richter’s Junod® and Yaxwer®, biosimilars to Amgen’s Prolia® and Xgeva® respectiv...

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 wholesale acquisition cost (WAC) information for commercially available bio...

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.  Halozyme is alleging that MSD’s subcutaneous formulation of Keytruda® (pembrolizumab) infringes 15 patents owned by...

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 on the Pharmaceutical Benefits Scheme (PBS).

Sandoz’s natalizumab biosimi...

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 first-line treatment for metastatic colorectal cancer patients who have ...

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).  The FDA had accepted Sanofi/Regeneron’s resubmitted supplemental Biologics Licence A...

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, 8mg injection) with extended dosing intervals (up to every 24 weeks) across al...