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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...

Outlook Therapeutics’ ophthalmic formulation of bevacizumab, Lytenava™ (ONS-5010, bevacizumab gamma), has been recommended by the National Institute for Health and Care Excellence (NICE) as a NHS treatment option for wet age-related macular degeneration (AMD).

Lytena...

On 31 October 2024, Daewoong Pharmaceutical announced that it has entered a joint sales agreement with Celltrion under which the two companies will jointly promote Celltrion’s CT-P41, biosimilar to Amgen’s Prolia® (denosumab), in Korea.  CT-P41 is scheduled to be launched i...

Organon and Shanghai Henlius Biotech announced on 30 October 2024 that the FDA accepted their BLA for HLX14, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).  This comes 5 months after the European Medicines Agency (EMA) validated Henlius’ and Organon’s applications fo...

On 30 October 2024, Celltrion announced results of a global phase 3, 2-year follow-up study comparing infliximab SC (CT-P13, Zymfentra™) as monotherapy and in combination with immunosuppressants.  Celltrion reports that the study found Zymfentra™ as monotherapy was just as ...