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In a joint press release on 18 March 2025, Alvotech and Dr Reddy’s announced that the US FDA has accepted their Biologic Licence Application (BLA) for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).

According to the companies, AVT03 will be supplied in a...

Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for February 2025.  Among the applications to be reviewed is a new indication for MSD’s Keytruda® (pembrolizumab) for patients with head and neck squamous...

On 14 March 2025, the US Court of Appeals for the Federal Circuit upheld the ruling of the District Court for the Northern District of Virginia refusing Regeneron’s application for a preliminary injunction preventing launch of Amgen’s Pavblu®/APB 938 (aflibercept), biosimil...

On 13 March 2025, Business Wire reported that Lumicera Health Services has entered into a purchase agreement with Anda, Inc., a Teva subsidiary, for unbranded ustekinumab, biosimilar to Janssen’s Stelara®.

Under the agreement, Lumicera’s discounted net acquisit...

On 13 March 2025, Celltrion announced that Steqeyma® (CT-P43), biosimilar to J&J’s/Janssen’s Stelara® (ustekinumab), is now available in the US for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis an...

On 12 March 2025, New Zealand’s Pharmac announces that it has entered an agreement with Pfizer to fund a range of drugs from 1 April 2025, including its Besponsa® (inotuzumab ozogamicin) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukaemia (ALL)....

On 12 March 2025, Australia’s Therapeutic Goods Administration (TGA) approved Amgen’s Uplizna® (Inebilizumab) for the treatment of adult patients with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive.

U...

On 12 March 2025, Australia’s Therapeutic Goods Administration approved three brands of Cipla’s liraglutide, making it the second approved generic to Novo Nordisk’s Saxenda® in Australia:

CIPLA LIRAGLUTIDE: liraglutide 6 mg/mL solution for injection pre-filled pen ...