Orion signs pembrolizumab biosimilar deal and starts first biologic trial
Finnish Orion Pharma has signed an agreement with Qilu Pharma Europe for a pembrolizumab biosimilar for the European market. A day earlier, it dosed the first patient with ODM-216, its first biologic drug candidate to reach clinical testing.
Under the October 6 agreement, Qilu will develop and supply an intravenous biosimilar of pembrolizumab, a checkpoint inhibitor used across several cancers. Orion receives exclusive rights to distribute, market and sell it in Europe. Qilu will receive a share of Orion’s profits plus development, regulatory and sales milestone payments. No amounts or launch timeline were disclosed.
On October 5, Orion dosed the first patient in BICIDES, a Phase 1/2 study of ODM-216 in patients with advanced solid tumors. ODM-216 is a bispecific antibody targeting PVRIG and PD-L1, two pathways that regulate the immune system’s response to cancer. It is also Orion’s first immuno-oncology candidate in clinical testing. It was developed in-house at Orion’s sites in Finland, the UK and the US, including its biologics R&D center in Cambridge, UK, which opened in 2025. The study will assess safety, pharmacokinetics and preliminary anti-tumor activity.
“We are pleased to expand our strategic partnership with Qilu,” said Satu Ahomäki, EVP Generics and Consumer Health at Orion Pharma.
Published: October 8, 2026
