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Accord BioPharma, a wholly-owned subsidiary of Intas Pharmaceuticals, announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for DMB-3115, its proposed biosimilar to Janssen’s Stelara®.

DMB-3115 was jointly devel...

Samsung Bioepis, Celltrion and Formycon have filed responses to Regeneron’s Motion for Alternative Service in each of their respective matters before the United States District Court for Northern District Of West Virginia regarding biosimilars to Eylea® (aflibercept).  Rege...

Glenmark Pharmaceuticals announced it has launched Lirafit®, the biosimilar to Novo Nordisk’s Victoza®/Saxenda® (liraglutide) in India.  Liralift® is priced at around INR100 for a standard dose (~AUD$1.80), a 70% price reduction compared to the originator product.  Lirafit®...

Alexion filed a complaint against Samsung in the US District Court for the District of Delaware asserting infringement of six US eculizumab patents.  The allegations relate to Samsung’s abbreviated Biologics License Application (aBLA)  for SB12, its biosimilar to Alexion’s ...

Alvotech announced positive top-line results for AVT06, its biosimilar to Regeneron’s Eylea® (aflibercept).   The study was a randomised, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 c...

Coherus Biosciences announced that it has launched Loqtorzi® (toripalimab-tpzi) in the US.  It was approved by the FDA on 27 October 2023 in combination with cisplatin and gemcitabine to treat adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NP...

AstraZeneca and Sanofi announced that Beyfortus® (nirsevimab) has been approved by the National Medical Products Administration (NMPA) in China for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in neonates and infants entering ...

Bristol Myers Squibb announced that the European Medicines Agency (EMA) has confirmed its submission is complete for its marketing authorisation (MA) for repotrectinib.  BMS is seeking approval of repotrectinib as a treatment for ROS1 TKI-naïve and pre-treated adult patient...

Cipla’s Adalicip®, developed by Alvotech (AVT02), biosimilar to AbbVie’s Humira® (adalimumab) has been listed on the PBS (General Pharmaceutical Benefits) in the 40mg/0.4mL dosage in syringes and pen devices.  It is reimbursed to treat various conditions, including Crohn...

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched its new International Recognition Procedure (IRP), allowing medicine developers to now submit applications.  The IRP replaces the EC Decision Reliance Procedure after the UK left the EU in 2016...