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On 18 May 2026, Accord BioPharma announced that the FDA has approved Immgolis™ and Immgolis Intri™ (golimumab) as interchangeable biosimilars to Janssen’s Simponi® and Simponi® Aria, respectively.  These are the first golimumab biosimilars to be approved in the US.

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On 15 May 2026, Roche subsidiary Genentech announced that the FDA has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) as adjuvant treatment for adults with muscle-invasive bladder cancer (MIBC) who have circulating tumour DNA ...

On 15 May 2026, the FDA approved BMS/Daiichi Sankyo’s Enhertu® (fam-trastuzumab deruxtecan-nxki) for two separate breast cancer indications.  The indications are:

followed, by taxane, trastuzumab and pertuzumab (THP) for neoadjuvant treatment of adults with HER-2 p...

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...