On 3 February 2026, Bio-Thera Solutions and Saudi-based Avalon Pharma announced that they have entered commercialisation and licence agreements for Bio-Thera’s BAT3306, biosimilar to MSD’s Keytruda® (pembrolizumab), in Saudi Arabia and MENA.
Under the agreement, Avalon will be responsible for seeking regulatory approvals and commercialisation in Saudi Arabia and MENA, while Bio-Thera will retain responsibility for development, manufacturing and supply of BAT3306.
Bio-Thera commenced an integrated Phase 1/III trial to evaluate the PK, efficacy and safety of BAT3306 in patients with non-squamous, non-small cell lung cancer (NSCLC) in July 2024. According to the US clinicaltrials.gov database, that trial was terminated in July 2025 on the basis that “new regulatory developments” have resulted in Bio-Thera concluding that “a Phase 3 study is no longer necessary for the development and approval of BAT3306”. Bio-Thera completed a Phase 1 study of BAT3306 in healthy male subjects in June 2024. It has started recruiting for a Phase 1 trial comparing the PK similarity of BAT2206 and Keytruda® in patients with early stage NSCLC, with an estimated completion dated in 2027.
In August 2025, Bioéticos launched the first pembrolizumab biosimilar in Paraguay under the name Pembrolizumab Bioéticos. In November 2025, Biocad’s Pembroria™ (pembrolizumab) was approved in Vietnam.
BAT3306 joins a raft of other pembrolizumab biosimilars currently in clinical trials, including Celltrion’s CT-P51 (Ph 3 trial plan approved by FDA in August 2024, initiated January 2025), Amgen’s ABP 234 (Ph 3 in early stage nsNSCLC initiated May 2024, Ph 3 in advanced or metastatic nsNSCLC commenced September 2024), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024), Sandoz’s GME751 (Ph 1 commenced in May 2024), Formycon’s FYB206 (Ph 1/3 trial commenced June 2024 in melanoma), Henlius’ HLX17 (approval for clinical trial received September 2024), mAbxience’s MB12 (Ph 3 study commenced December 2024).
In June 2025, Alvotech and Dr Reddy’s announced that they entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a pembrolizumab biosimilar. In December 2025, Formycon announced agreements with MS Pharma for the commercialisation of pembrolizumab biosimilar FYB206 in the MENA region and with Zydus Lifesciences for the US and Canada.