On 3 February 2026, Amgen announced its financial results for Q4/2025 and full year 2025, including providing the following update on its biosimilar pipeline:
- Nivolumab: Amgen has completed enrolment in a comparative clinical study comparing ABP 206 (nivolumab) with the reference product, BMS’ Opdivo®, in patients with early-stage non-squamous NSCLC as adjuvant treatment. According to the US clinicaltrials.gov database, Amgen completed a Phase 3 study to compare the pharmacokinetic similarity of ABP 206 with Opdivo® in patients with resected advanced melanoma in October 2025.
- Ocrelizumab: A pharmacokinetic similarity/comparative clinical study of ABP 692 compared to Genentech/Roche’s Ocrevus® is enrolling patients with relapsing-remitting multiple sclerosis. Amgen announced this Phase 3 study at the JP Morgan Annual Healthcare conference on 13 January 2025.
- Pembrolizumab: Two clinical trials are underway. Amgen completed enrolment in a combined pharmacokinetic/comparative clinical study of ABP 234 (pembrolizumab) with MSD’s Keytruda® in patients with advanced or metastatic non-squamous NSCLC (initiated May 2024) and is currently enrolling patients in a pharmacokinetic similarity study comparing ABP 234 with Keytruda® in patients with early-stage non-squamous NSCLC as adjuvant treatment.
Amgen reported that its biosimilars segment delivered US $3 billion in 2025 sales, an increase of 37% year-over-year, with particularly strong performance from Pavblu®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), which reached US $700 million in full year sales. Pavblu® was the first aflibercept biosimilar launched in the US in October 2024 and remains the only aflibercept biosimilar on the US market to date (following settlements, launches of Biocon’s, Formycon/Klinge’s, Sandoz’s, Celltrion’s and Alvotech/Teva’s aflibercept biosimilars are planned in the second half of 2026). At the same time, Amgen acknowledged that biosimilars are applying competitive pressure in relation to sales of Prolia® and Xgeva® (denosumab).
Nivolumab, pembrolizumab and ocrelizumab biosimilars have been developed, or are in development, by a number of other companies:
- Nivolumab: In January 2026, Zydus was the first to market its nivolumab biosimilar, Tishtha®, in India. Sandoz, Xbrane/Intas, Boan Biotech, Shanghai Henlius, Enzene, Reliance Life Sciences and Biocon all have nivolumab biosimilars in their pipelines.
- Ocrelizumab biosimilars are in clinical trials sponsored by Biocad (Phase III, enrolment commenced November 2025), Sandoz (comparative pharmacokinetic trial underway), and Celltrion (Phase III IND for CT-P53 partially approved by the EMA in August 2023). Samsung Bioepis announced in January 2026 that it had added an ocrelizumab biosimilar to its pipeline.
- Pembrolizumab: 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. 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.