On 15 May 2026, Sandoz announced that the European Commission has granted marketing authorisation for Bysumlog®, biosimilar to Eli Lilly’s Humalog® (insulin lispro), and Dazparda®, biosimilar to Novo Nordisk’s NovoRapid® (insulin aspart). Both biosimilars are approved for ...
On 15 May 2026, Alteogen announced that the Korean Ministry of Food and Drug Safety (MFDS) has granted marketing authorisation for Eyzanfy™/ALT-L9 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea® 2mg, for all approved reference indications. The approval comes 20 month...
Less than one month after receiving approval for generic equivalents of Novo Nordisk’s Ozempic® in Canada, Apotex and Dr Reddy’s have launched their generic semaglutide products on the Canadian market.
Apotex announced its launch of Apo-Semaglutide Injection™ on 14 M...
On 13 May 2026, Zydus Lifesciences announced that it has entered into a definitive agreement to acquire all outstanding shares of Assertio Holdings in an all-cash transaction valued at US$166.4 million.
Under the terms of the merger, Zydus will commence a tender offe...
Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 8 May 2026 are set out below:
On 12 May 2026, Bristol Myers Squibb (BMS) and Hengrui Pharma announced that they have entered into global strategic collaboration and licence agreements to advance 13 early stage innovative medicines across oncology, haematology and immunology. The transaction is expected...
On 12 May 2026, Celltrion announced that it has acquired a 100% stake in France-based healthcare firm, Gifrer. Gifrer operates more than 9,000 pharmacy sales channels and supply networks covering about 800 hospitals across France and will continue to operate independently ...
On 12 May 2026, the US Patent Trial and Appeal Board (PTAB) issued a final written decision invalidating Halozyme’s US Patent No. 11,952,600 relating to modified PH20 hyaluronidase polypeptides. The patent is one of a number of patents relating to Halozyme’s MDASE™ technol...
With a number of biosimilars to MSD’s Keytruda® (pembrolizumab) currently in clinical trials, we provide the following update on those trials and their status, based on previous reports and the information available to date in the ClinicalTrials.gov registry.
On 11 May 2026, Alvotech announced plans to resubmit Biologics License Applications for aflibercept (AVT06), denosumab (AVT03) and golimumab (AVT05) biosimilars in the US, following completion of an FDA “routine cGMP surveillance inspection” of the Alvotech Iceland manufact...
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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