On 20 May 2026, Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety has approved MSD’s Keytruda SC™ (pembrolizumab and berahyaluronidase alfa) for 35 indications across 18 cancer types. MSD plans to launch the product in Korea in Q4/2026.
This follows approval of Keytruda SC™ in Canada in February 2026 and in Europe in November 2025. MSD’s subcutaneous formulation of pembrolizumab was also approved in the US, as Keytruda Qlex™, in September 2025 across 38 indications.
Halozyme has commenced patent infringement litigation against MSD in relation to subcutaneous pembrolizumab in Germany and the US. In December 2025, the Munich Regional Court granted a preliminary injunction to Halozyme, preventing MSD from distributing and offering for sale in Germany Keytruda SC™. The decision was based on a finding of the Court that there was imminent infringement of one of Halozyme’s European MDASE™ patents, EP 2797622, in relation to modified PH20 hyaluronidase polypeptides and compositions. Earlier in May 2026, MSD was successful in invalidating one of Halozyme’s US patents before the US Patent Trial and Appeal Board (PTAB). MSD has a further 17 petitions pending before PTAB.
While there are no reports of biosimilar subcutaneous pembrolizumab development to date, there are multiple pembrolizumab biosimilars approved or in development. Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025) and Jordan (by Sana Pharma in February 2026). Pembrolizumab biosimilars are also in clinical trials including by Formycon, Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene.
Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a Keytruda® biosimilar and Bio-Thera and Avalon are partnering on commercialisation of a pembrolizumab biosimilar (BAT3306) in Saudi Arabia/MENA. Formycon has announced agreements for commercialisation of pembrolizumab biosimilar FYB206 with MS Pharma for the MENA region, Zydus Lifesciences for the US and Canada, and Lotus for the Asia-Pacific.