Read our latest updates & insights

Novo Nordisk has commenced Hatch-Waxman litigation in the US against both Cipla and Apotex in relation to their generic versions of Novo Nordisk’s semaglutide products.

Most recently, on 17 July 2026, Novo Nordisk filed a Complaint against Cipla in the US District Co...

On 16 July 2026, Organon and Samsung Bioepis announced the expansion of their development and commercialisation agreement for Australia, to include a new biosimilar.  While the biosimilar has not been named by Organon or Samsung Bioepis, Pharma in Focus has suggested that i...

On 16 July 2026, Shanghai Henlius Biotech announced that the first patient in China has been dosed in its international multicentre Phase 1 clinical trial of HLX18, biosimilar to BMS’ Opdivo® (nivolumab).

Henlius received approval from China’s National Medical ...

On 15 July 2026, Sun Pharma announced that the South African Health Products Regulatory Authority (SAHPRA) has approved its semaglutide injection, generic equivalent of Novo Nordisk’s Ozempic® (semaglutide) for the treatment of adults with type 2 diabetes mellitus.  The lau...

On 15 July 2026, Celltrion announced that South Korea’s Ministry of Food and Drug Safety (MFDS) has approved its investigational new drug application to commence a Phase 1 clinical trial of CT-P68, biosimilar to Janssen’s Tremfya® (guselkumab).

The Phase 1 trial will...

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...