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On 5 November 2024, the Australian Register of Therapeutic Goods (ARTG), published 5 approvals of new brands for Amgen’s denosumab, confirming Amgen’s belief that biosimilar competition is imminent.  This news follows Australian approval of Sandoz’s denosumab biosimilars, J...

Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for the months of August, September and October.

Among the new applications to be reviewed is Freyr’s new application for liraglutide (Lobezy...

On 4 November 2024, Alvotech and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted their marketing authorisation application (MAA) for AVT05, biosimilar to Janssen’s Simponi® (golimumab), for treatment of several chronic inflammatory diseases.  T...

NYSE-listed telehealth provider, Hims & Hers Health Inc, announced in its third quarter 2024 earnings conference call that it plans to bring generic liraglutide to its platform in 2025.  The company says it has already confirmed a core supplier and expects to complete t...

On 4 November 2024, the Korea Hearld reported that Celltrion has launched SteQeyma®, biosimilar to Janssen’s Stelara® (ustekinumab), in Germany and the Netherlands.  At the same time, the Korea Herald reported that Celltrion has already secured a bid from the Dutch pharmace...

On 1 November 2024, Novo Nordisk announced positive results from part 1 of a pivotal phase 3 study evaluating the effects of once-weekly semaglutide 2.4 mg in adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis.

On 31 October 2024, New Zealand’s drug funding body, Pharmac, announced that it is seeking feedback on a proposal to broaden the reimbursement for Amgen’s denosumab products Xgeva® and Prolia®.

Both Xgeva® (70mg/ml solution for injection, for various bone-related can...

Following the FDA granting Fast Track designation, Eisai reports that it has completed its rolling submission of a Biologics License Application (BLA) to the FDA for Leqembi® (lecanemab-irmb) subcutaneous autoinjector for weekly maintenance dosing for the treatment of early...