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On 14 October 2024, UCB announced that the US FDA has approved a 2 mL pre-filled syringe and pre-filled autoinjector, each containing 320 mg of Bimzelx® (bimekizumab-bkzx), adding to the already approved 1 ml (160 mg) device presentation.

On 23 September 2024, UCB re...

On 14 October 2024, AstraZeneca, in partnership with Daiichi Sankyo, announced that Enhertu® (trastuzumab deruxtecan) has received conditional approval in China for use as monotherapy in patients with unresectable, locally advanced or metastatic non-small cell lung cancer w...

On 11 October 2024, Pfizer announced that the US FDA has approved its Hympavzi™ (marstacimab-hncq) for the treatment of adults and adolescents with haemophilia A or B without inhibitors.  The approval is based on results from the Phase 3 BASIS trial (NCT03938792) demonstrat...

On 9 July 2024, Roche received a temporary injunction order against Zydus from a previous bench of the Delhi High Court, restraining Zydus from marketing or selling their product Sigrima™, biosimilar to Roche’s Perjeta® (pertuzumab), till the next date of hearing.

Th...

On 11 October 2024, Meiji Seika Pharma Co., Ltd. announced that the US Food and Drug Administration (FDA) has approved its Imuldosa™ (DMB-3115, ustekinumab-srlf), biosimilar to Janssen’s Stelara® (ustekinumab).

The FDA approval follows Accord BioPharma’s announcement...

On 10 October 2024, Samsung Bioepis released its quarterly US Biosimilar Market Report.  The report has been published every quarter since April 2023 and details average sales price information for US launched biosimilars and market share and price trends.
The Q4 2024...

New Zealand’s drug-funding body, Pharmac, has announced that Eli Lilly/Merck KgGa’s Erbitux® (cetuximab) will now be funded for left-sided, RAS and BRAF wild-type, metastatic colorectal cancer.  Minor amendments have also been made to eligibility criteria for currentl...

On 10 October 2024, Johnson & Johnson (J&J) announced that it submitted a Type II variation application to the EMA seeking an indication extension for Darzalex® (daratumumab) subcutaneous formulation in combination with bortezomib, lenalidomide and dexamethasone for...