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On 24 February 2025, Sandoz announced the US launch of Pyzchiva® (ustekinumab-ttwe), biosimilar to J&J/Janssen’s Stelara®.  On the same date, Biocon Biologics announced the US launch of Yesintek™ (ustekinumab-kfce/Bmab 1200).

Pyzchiva® was developed by Samsung Bi...

On 24 February 2025, Johnson & Johnson (J&J) and Janssen Biotech filed a complaint in the US District Court for the District of New Jersey alleging that Samsung Bioepis has breached a settlement and licence agreement entered in July 2023 (announced in November 2023)...

On 24 February 2025, Celltrion announced that the European Commission has approved Avtozma® (CT-P47), biosimilar to Roche’s RoActemra® (tocilizumab).  Avtozma® is approved for all indications of RoActemra®, including moderate to severely active rheumatoid arthritis (RA), ac...

Following the FDA’s decision on 21 February 2025 to remove Novo Nordisk’s semaglutide products (Ozempic® and Wegovy®) from the Drug Shortages List, the regulator has been sued by the Outsourcing Facilities Association, a compounding industry group, and FarmaKeio Superior Cu...

BMS has announced that the FDA has accepted a supplemental biologics licence application (sBLA) for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a potential first-line treatment option for adult and paediatric patients (12 years and older) with unresectable or metastati...

On 21 February 2025, Alvotech and Teva announced the US launch of Selarsdi® (AVT04, ustekinumab-aekn for injection), biosimilar to J&J/Janssen’s Stelara®.

This follows Alvotech’s and Teva’s US ustekinumab settlement with Johnson & Johnson in June 2023, which ...

On 21 February 2025, the FDA announced that the US semaglutide injection product shortage has resolved, such that semaglutide can now be removed from the drug shortages list.  The FDA has confirmed it will take action from 22 April 2025 against state-licensed pharmacies whi...

On 21 February 2025, Korean Economic Daily reported that Samsung Bioepis has succeed in a patent dispute regarding Afilivu® (SB15), biosimilar to Regeneron’s Eylea® (aflibercept).  Regeneron had commenced the proceeding in January 2023 in the Seoul Central District Court se...