On 25 June 2026, MSD announced that the FDA has approved each of Keytruda® (pembrolizumab) and Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph), in combination with Gilead’s Trodelvy® (sacituzumab govitecan-hziy) for the first-line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA-authorised test. According to the announcement, these approvals represent the first regimen of a PD-1 inhibitor plus Trop-2 directed antibody-drug conjugate (ADC) in advanced TNBC.
The US approvals came a day after it was announced that Keytruda® was approved in Europe, in combination with Astellas’ Padcev™ (enfortumab vedotin), as neoadjuvant treatment (before surgery) and then continued after radical cystectomy (surgery) as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy in the EU.
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.