On 9 June 2025, the US Patent Trial and Appeal Board issued a written decision invalidating all claims of Johns Hopkins University’s US Patent No. 11,591,393 on the basis of anticipation and obviousness. US Patent No. 11,591,393 is directed to treating patients with micros...
On 9 June 2025, Celltrion announced that its Qoyvolma® (CT-P43), biosimilar to J&J/Janssen’s Stelara® (ustekinumab) has received marketing approval from the European Commission (EC). Qoyvolma® is Celltrion’s second European ustekinumab biosimilar, following Steqeyma®, ...
On 5 June 2025, Formycon announced that Brazil’s ANVISA has granted marketing authorisation for Ranivisio® (FYB201), biosimilar to Genentech’s Lucentis® (ranibizumab).
Formycon expects that Ranivisio® will be launched in Brazil in Q4 2025 by its commercialisation par...
On 5 June 2025, Alvotech and Dr Reddy’s announced that they have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to MSD’s Keytruda® (pembrolizumab).
Under the agreement, Alvotech and Dr Reddy’s will ...
On 4 June 2025, Sandoz Australia published a white paper entitled “Pioneering Access for Patients Through Biosimilar Medicines” which outlines proposals for reducing healthcare costs and expanding patient access to biosimilars in Australia. The white paper is the outcome o...
On 4 June 2025, Alvotech announced that it has completed the acquisition of Xbrane’s Swedish R&D operations, as well as XB003, biosimilar to UCB’s Cimzia® (certolizumab pegol), in a deal worth US$28.9m. The deal was initially announced by Alvotech in March 2025, and wa...
Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the fortnight ending 30 May 2025 are set out be...
On 2 June 2025, Biocon announced that its generic liraglutide has been approved by India’s Central Drugs Standard Control Organisation (CDSCO) in 6 mg/ml solution for injection in pre-filled pen and cartridge.
Biocon’s liraglutide, the generic version of Novo Nordisk...
On 2 June 2025, ChosunBiz reported that Celltrion has launched Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), in Korea. Avtozma® was approved by Korea’s Ministry of Food and Drug Safety in December 2024 for the same indications as Actemra®.
On 2 June 2025, Outlook Therapeutics announced that it has launched Lytenava™ (bevacizumab gamma) in the UK and Germany, for the treatment of nAMD. Lytenava™ is the first and only authorised ophthalmic formulation of bevacizumab in the EU and UK.
Pearce IP publishes free e-books addressing various aspects of patent law and practice in Australia, with a focus on issues affecting pharmaceutical, biopharmaceutical and other life sciences companies.
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