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On 14 July 2026 The District Court of The Hague published its judgment dismissing Halozyme’s application for a preliminary injunction (PI) to prevent MSD from marketing Keytruda SC™ (pembrolizumab and berahyaluronidase alfa) in Denmark and Sweden pending the outcome of subs...

On 14 July 2026, Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety (MFDS) is implementing a revised notice on the Regulation on Approval and Review of Biological Products.  The revisions permit Phase 3 clinical trial data to be waived for biosim...

On 14 July 2026, Formycon and OneSource Speciality Pharma announced that they have entered into a strategic manufacturing partnership for biosimilars.  OneSource is an Indian-based specialty pharma Contract Development & Manufacturing Organisation (CDMO) that provides e...

On 14 July 2026, ChosunBiz reported that Celltrion has voluntarily terminated the European Phase 3 trial of CT-P51, biosimilar to MSD’s Keytruda® (pembrolizumab), and has withdrawn its investigational new drug application.  The early termination of the trial in Europe is pa...

On 14 July 2026, Merck KGaA announced that Erbitux® (cetuximab) was approved by the European Commission for adults with BRAF V600E mutant metastatic colorectal cancer (mCRC) in combination with Pierre Fabre’s Braftovi® (encorafenib) and FOLFOX (fluorouracil, leucovori...

On 13 July 2026, Seoul Economic Daily reported that Samsung Bioepis has secured US formulary listings for Pyzchiva®/SB17, with two major pharmacy benefit managers (PBMs).

Pyzchiva® was listed as a preferred drug by CVS Caremark from 1 July 2026, following the inclusi...

On 13 July 2026, Shanghai Henlius Biotech announced that the first patient in the US has been dosed in its international multicentre Phase 1 clinical trial of HLX-15-SC (daratumumab and hyaluronidase-fihj), biosimilar to J&J’s Darzalex Faspro®, for the treatment o...

On 10 July 2026, the FDA announced that it approved each of MSD’s Keytruda® (pembrolizumab) and Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Astellas’ Padcev® (enfortumab vedotin), as neoadjuvant treatment followed by adjuvant treatment...