On 12 June 2026, the FDA announced that it approved MSD’s Keytruda® (pembrolizumab) or Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) in combination with MSD’s Welireg® (belzutifan) for the adjuvant treatment of adults with renal cell carcinoma with a clear cell component at intermediate high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
The FDA reviewed the combination under Project Orbis, an initiative of the FDA’s Oncology Center of Excellence that provides a framework for the collaborative review of new cancer treatments among international regulatory partners. For this review, FDA collaborated with the Australian Therapeutic Goods Administration (TGA) and Health Canada. The application reviews are ongoing at the other regulatory agencies.
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).
There are multiple pembrolizumab biosimilars in development. Formycon’s FYB206 appears to be the front runner, having demonstrated pharmacokinetic bioequivalence with Keytruda® in its “Dahlia” study (reported in February 2026). Formycon’s US commercialisation partner, Zydus, has expressed optimism that it is well-placed to file the first BLA in the US for biosimilar pembrolizumab. Formycon has also announced agreements for commercialisation of pembrolizumab biosimilar FYB206 with MS Pharma for the MENA region, and Lotus for the Asia-Pacific.
Other companies with pembrolizumab biosimilars in clinical trials include Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene. Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a Keytruda® biosimilar and Bio-Thera and Avalon are partnering on commercialisation of a pembrolizumab biosimilar (BAT3306) in Saudi Arabia/MENA.