On 6 January 2026, Biocon Biologics announced that it will unveil three new biosimilars at the 2026 J.P. Morgan Healthcare Conference to be held 12-16 January 2026 in San Francisco. The as yet unnamed biosimilars are for pembrolizumab (referencing MSD’s Keytruda®), nivolumab (referencing BMS’ Opdivo®) and trastuzumab/hyaluronidase (referencing Roche’s Herceptin® SC, marketed in the US as Herceptin Hylecta™). The stage of development of each of the biosimilars is not yet known.
Bioéticos claimed to have launched the first pembrolizumab biosimilar in Paraguay in August 2025 under the name Pembrolizumab Bioéticos. In November 2025, Biocad’s Pembroria™ (pembrolizumab) was reportedly approved in Vietnam. A number of other pembrolizumab biosimilars are currently in clinical trials, including by Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera and BioNTech. Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to Keytruda®. 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.
There are a number of nivolumab biosimilars already undergoing clinical trials, including Sandoz’s JPB898 (phase I), Amgen’s ABP 206 (phase III), Xbrane/Intas’ Xdivane™ (phase I/III), Boan Biotech’s BA1104 (phase III), and Reliance Life Sciences’ R-TPR-067 (phase I/III). In December 2025, Shanghai Henlius announced that the FDA approved an IND for a phase I trial of HLX18 (nivolumab).
Celltrion announced in December 2025 that it has been conducting clinical trials for Herzuma® SC (CT-P6 SC), biosimilar to Roche’s Herceptin® SC/Herceptin Hylecta™, since February 2025 and plans to submit applications for approvals of the Herzuma® SC formulation to domestic and foreign regulatory agencies in the first half of 2026.