On 17 February 2026, MSD announced that Health Canada has approved Keytruda SC™ (pembrolizumab), a subcutaneous (SC) formulation of pembrolizumab injection for multiple cancer indications.
The Canadian approval follows European approval of Keytruda SC™ in November 2025, after a positive recommendation from the EMA’s CHMP in September 2025. However, 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.
MSD’s subcutaneous formulation of pembrolizumab was approved in the US, as Keytruda Qlex™, in September 2025 across 38 indications. Halozyme has also sued MSD in the US in relation to SC pembrolizumab.
While there are no reports as yet of biosimilar subcutaneous pembrolizumab, 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). Pembrolizumab biosimilars are also in clinical trials including by Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera and BioNTech.
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.