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On 30 June 2025, Amgen filed BPCIA litigation against Biocon in the in the US District Court for the District of Massachusetts, Eastern Division, asserting infringement of 34 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing t...

The results of a phase I study published in Annals of Medicine is said to have established biosimilarity between Beijing SL Pharmaceuticals’ pertuzumab biosimilar, KM118, and the reference product, Roche’s Perjeta®.

Roche has previously claimed it is unconcerned abou...

On 27 June 2025, Bayer announced that the European Commission has granted a label extension for Eylea™ 8mg (aflibercept, 114.3mg/ml solution for injection) with extended treatment intervals of up to 6 months for the treatment of nAMD and visual impairment due to diabetic ma...

On 27 June 2025, Biocon Biologics announced that Yesafili™, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg) has been approved by Health Canada in vial and PFS presentations, becoming the first aflibercept biosimilar approved in Canada.  It is indicated for nAMD, v...

On 26 June 2025, Formycon announced that it has entered into a non-exclusive distribution agreement with Teva Group’s subsidiary, Ratiopharm GmbH, to commercialise FYB202/Fymskina®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in Germany.  German launch of Fymski...

On 26 June 2025, New Zealand Doctor reported that Novo Nordisk is set to launch Wegovy® (semaglutide) in New Zealand from 1 July 2025.

New Zealand’s Medsafe approved Wegovy® in March 2025 for two indications:

an adjunct to a reduced-calorie diet and increase...

On 25 June 2025, Amgen filed BPCIA litigation in the US District Court for the District of New Jersey against Hikma Pharmaceuticals/Gedeon Richter and Shanghai Henlius Biotech/Organon, asserting infringement of multiple US patents (32 for Hikma/Richter and 26 for Henlius/Or...

On 25 June 2025, Bio-Thera Solutions, Ltd. and Costa Rican-based SteinCares announced that they have signed an agreement to commercialise biosimilar dupilumab across Latin America.  Under the agreement, Bio-Thera will be responsible for product development and supply, while...

On 25 June 2025, Formycon announced that Klinge Biopharma, its exclusive global licensee of FYB203/Ahzantive®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2 mg), has entered an exclusive licence agreement with Valorum Biologics for commercialisation of FYB203 in th...