On 24 February 2026, Sana Pharma announced that Pembrava™, biosimilar to MSD’s Keytruda® (pembrolizumab), has been registered by the Jordan Food and Drug Administration for cancer treatment. Sana Pharma claims that Pembrava™ is the first biosimilar for cancer treatment in Jordan.
Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025). There are a number of pembrolizumab biosimilars in clinical trials including Amgen’s ABP 234 (Ph 3 in early stage nsNSCLC initiated May 2024, Ph 3 in advanced or metastatic nsNSCLC commenced September 2024), Bio-Thera’s BAT3306 (integrated PhI/III trial commenced, Ph 3 terminated July 2025 due to regulatory developments), Celltrion’s CT-P51 (Ph 3 trial approved by FDA in August 2024, initiated January 2025), Formycon’s FYB206 (Ph 1/3 trial commenced June 2024 in melanoma), Sandoz’s GME751 (Ph 1 commenced in May 2024, estimated completion July 2026), mAbxience’s MB12 (Ph 3 study commenced December 2024, estimated completion June 2026), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024, expected completion September 2026) and Shanghai Henlius’ HLX17 (approval for clinical trial received September 2024). Biocon and Alvotech have pembrolizumab biosimilars in their pipelines.