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On 3 March 2025, Celltrion announced that it has received US FDA approval for Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for the same indications as the reference medicines.  The approval follows European approval ...

On 3 March 2025, Genevant Sciences and Arbutus Biopharma announced that they have jointly filed five international lawsuits seeking to enforce patents protecting their lipid nanoparticle (LNP) technology against Moderna and certain affiliates.  Genevant and Arbutus are seek...

On 1 March 2025, Sandoz’s high-concentration Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab) 100mg/mL (80 mg/0.8 mL injection, 0.8 mL pen) was PBS listed for all Humira® indications.

This follows PBS-listing of Hyrimoz® 100mg/mL (40 mg/0.4 mL injection, 2 x 0.4...

On 28 February 2025, Amgen filed petitions for inter partes review (IPR) challenging the validity of three of Bristol Myers Squibb’s US patents relating to methods of treatment using nivolumab and ipilimumab for cancer generally (US 9856320), melanoma (US 10174113) and colo...

At its February 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended expanded therapeutic indications for 16 medicines, including the following six biopharmaceuticals.

The CHMP adopted a positive opinion for ...

On 28 February 2025, Biocon announced that it has launched its liraglutide products in the UK.  The products are generic versions of Novo Nordisk’s Victoza®, to treat type 2 diabetes, and Saxenda®, used in the treatment of weight management.  Biocon’s products are marketed ...

On 28 February 2025, Regeneron announced that the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended conditional marketing authorisation of Lynozyfic® (linvoseltamab) for treatment of adults with relapsed and refractory multiple...

On 28 February 2025, Biogen and Eisai announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has reaffirmed its positive opinion for Leqembi® (lecanemab) for early Alzheimer’s disease.

In late January 2025, the European C...

On 28 February 2025, Outlook Therapeutics announced that it has resubmitted its Biologics Licence Application (BLA) to the US FDA for ONS-5010 (Lytenava™, ophthalmic bevacizumab-vikg) for the treatment of wet AMD.

The resubmission is based on positive results of the ...

On 26 February 2025, Regeneron announced that the US FDA has accepted for review the resubmission of the BLA for odronextamab for the treatment of relapsed/refractory follicular lymphoma (R/R FL).  The FDA’s PDUFA target action date is 30 July 2025.

Regeneron’s odron...