On 6 October 2026, Nordic-based Orion Pharma announced that it has entered into a European commercialisation agreement with China-headquartered Qilu Pharma, for Qilu’s intravenous QL2107, biosimilar to MSD’s Keytruda® (pembrolizumab).
Under the agreement, Orion has the exclusive right to distribute, market and sell Qilu’s biosimilar pembrolizumab in Europe, while Qilu will supply the product to Orion and is entitled to receive certain confidential development and regulatory milestone payments.
This follows the September 2026 announcement that Qilu has partnered with InvaGen Pharmaceuticals Inc., a wholly owned subsidiary of Cipla Limited, for the US commercialisation of QL2107 (pembrolizumab).
In January 2025, Qilu initiated a Phase 3 study for QL2107, to compare the efficacy and safety of QL2107 vs Keytruda® in combination with chemotherapy in treating metastatic non-squamous non-small-cell lung cancer. The study has an estimated primary completion date of December 2026.
There are multiple pembrolizumab (IV) biosimilars approved or in development. Samsung Bioepis and Celltrion each applied for Korean approval of their pembrolizumab biosimilars in August 2026 (SB27 and CT-P51, respectively). 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 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 mAbxience, Sandoz, Bio-Thera, Shanghai Henlius, BioNTech and Enzene.