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On 11 August 2026, Mabwell announced that it has entered into licensing and commercialisation agreements with unidentified partners in the Philippines, Vietnam and Malaysia for 9MW0813, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) 2mg.

Under the terms of the ...

On 10 August 2026, Samsung Bioepis announced that it has applied to Korea’s Ministry of Food and Drug Safety for approval of SB27, biosimilar to MSD’s Keytruda® (pembrolizumab).  According to Samsung Bioepis, this application puts it ahead of competitor pembrolizumab biosim...

On 10 August 2026, Samsung Bioepis announced the European launch of Opuviz®/SB15 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea® 2mg in a pre-filled syringe (PFS) presentation (40 mg/mL).  Opuviz® was the third aflibercept biosimilar to be approved in the EU in Novemb...

On 10 August 2026, Amneal Pharmaceuticals announced the completion of its acquisition of Kashiv BioSciences.  This follows the companies entering into a definitive agreement in April 2026, and is in line with their expectations of a H2/2026 closing.

The acquisition c...

On 6 August 2026, Replimune announced that its vusolimogene oderparepvec-wtpg, formerly known as RP1 but newly branded as Tudriqev™, has received accelerated approval from the FDA for the treatment of adults with unresectable advanced cutaneous melanoma who experienced dise...

On 5 August 2026, Novo Nordisk announced that The Hague District Court granted a preliminary injunction (PI) preventing Ceban Ziekenhuisfarmacie B.V. (a retail pharmacy based in the Netherlands) from selling a compounded semaglutide nasal spray under the name Semanova.  To ...

On 3 August 2026, Ono Pharmaceutical reported that Opdivo® (nivolumab) was approved by South Korea’s Ministry of Food and Drug Safety (MFDS) for neoadjuvant treatment of adult patients with resectable non-small cell lung cancer (NSCLC) and no known epidermal growth factor r...

On 3 August 2026, Biocon announced the US launch of Yesafili™ (aflibercept), biosimilar to Regeneron’s Eylea® 2 mg.

Yesafili™ was one of the first approved interchangeable aflibercept (2 mg) biosimilars in the US in May 2024.  Biocon and Regeneron settled US BPCIA li...

On 1 August 2026, the Economic Times reported that the FDA has approved Dr Reddy’s biosimilar to Genentech’s Rituxan® (rituximab).  The product will be commercialised in the US by Fresenius Kabi.

The FDA approval follows a Complete Response Letter (CRL) issued to Dr ...