On 17 September 2026, India-based contract development and manufacturing organisation (CDMO) Shilpa Biologicals announced that it has signed an exclusive licence and commercialisation agreement with Saudi Arabia-based SPIMACO Bio for a “portfolio of PD-1 inhibitor biosimilars” across the Middle East and North Africa (MENA). While the press release does not name the specific products covered by the agreement, the only PD-1 inhibitors that Shilpa currently identifies in its pipeline are biosimilars to MSD’s Keytruda® (pembrolizumab) and BMS’ Opdivo® (nivolumab).
Under the terms of the agreement, Shilpa has responsibility for the exclusive development and manufacturing of the biosimilars, together with a phased technology transfer to establish local biosimilar manufacturing in Saudi Arabia, while SPIMACO is responsible for regulatory filings, market access, and commercialisation across the region.
The agreement with SPIMACO follows a June 2026 agreement between Shilpa and Orion Pharma in relation to the European commercialisation of Shilpa’s intravenous nivolumab biosimilar.
Competition is heating up in relation to the first PD-1 inhibitor biosimilar to be approved in major markets. Amgen has become the first known company to file an application with the FDA for a biosimilar to BMS’ Opdivo®, having disclosed the US filing of its aBLA for ABP 206 (nivolumab) on 15 September 2026. Meanwhile, two biosimilars have been launched in India (Zydus’ Tishtha™ (January 2026) and Dr Reddy’s Nivorz® (September 2026)), and multiple nivolumab biosimilars are under development, including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, and Boan Biotech’s BA1104.
Applications for approval of pembrolizumab biosimilars were filed in Korea by Samsung Bioepis (SB27) and Celltrion (CT-P51) in August 2026. Two months earlier, in June 2026, Samsung Bioepis claimed to be the first developer of a pembrolizumab biosimilar to announce global phase 3 trial results. Amgen also confirmed on 15 September 2026 that its Keytruda® biosimilar has successfully completed clinical trials with an FDA submission likely later this year. Formycon announced successful Phase 1 results in February 2026, with its US commercialisation partner, Zydus, expressing optimism that it is well-placed to file the first BLA in the US for biosimilar pembrolizumab. Pembrolizumab biosimilars are also in clinical trials including by mAbxience, Sandoz, Bio-Thera, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene.
Keytruda® 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).