Biosimilars Market: Interchangeability, Patent Expiry and the Checkpoint Inhibitor Pipeline
The Biosimilars Market comprises biological medicines shown to be highly similar to an already approved reference biologic, with no clinically meaningful differences in safety, purity or potency. In the US, they are approved through the abbreviated 351(k) pathway established under the Biologics Price Competition and Innovation Act. Polaris Market Research values the market at USD 35.22 billion in 2025 and USD 37.54 billion in 2026, projecting USD 73.24 billion by 2036 at a 6.9% CAGR from 2026 to 2036. Growth is driven by patent expiry of high-revenue biologics, rising FDA approvals and expanding interchangeable designations.
Patent Expiry Is Expanding the Pipeline
Patent expiry and exclusivity changes are creating opportunities for manufacturers to develop competing products. This patent cliff is increasing development activity around pembrolizumab, nivolumab, omalizumab, ocrelizumab and high-dose aflibercept. Projected US exclusivity changes around 2028 for pembrolizumab and nivolumab are encouraging manufacturers to advance clinical programs. Keytruda's primary compound patent expires in December 2028, although further patents run to 2029 and are expected to be litigated. Merck expects Keytruda competition as early as December 2028, and Keytruda made up 49% of its 2025 sales. As programs multiply, manufacturers also build out manufacturing capacity, regulatory capabilities and commercialization plans.
Checkpoint Inhibitor Biosimilars Define the Next Cycle
PD-1 inhibitors are now the center of gravity of the pipeline. Samsung Bioepis reported positive preliminary Phase 1 and Phase 3 data for SB27, a proposed Keytruda biosimilar, on 29 June 2026. Formycon's FYB206 demonstrated pharmacokinetic bioequivalence in February 2026, and Amgen's ABP 234 is in Phase 3 with primary completion revised to December 2026. On the nivolumab side, Amgen's ABP 206 has been submitted to the FDA, with a decision expected by the end of 2026, and on 8 September 2026 Bristol Myers Squibb and Ono filed a BPCIA suit asserting seven patents. Teva's omalizumab filings were accepted by the FDA and EMA on 30 March 2026, with an FDA decision expected in Q1 2027. Sandoz is building its own position through partners, adding Henlius in August 2026 to lift its pipeline to 39 assets.
Oncology held about 38.64% of the market in 2025 and is expected to register an 8.36% CAGR during 2026 to 2036. Checkpoint inhibitor biosimilars, together with omalizumab biosimilars, are expected to grow at a 10.63% CAGR. Indication extrapolation can widen the addressable population when regulatory requirements are met, although oncology developers must satisfy regulators for each claimed indication.
Interchangeable Biosimilars and Pharmacy-Level Substitution
Interchangeable biosimilars meet additional FDA requirements, so, depending on state pharmacy law, they can be substituted at the pharmacy without the prescriber's intervention. This pharmacy-level substitution is where the designation matters commercially. Interchangeable biosimilars are projected to grow at an 8.92% CAGR through 2036, the fastest in their segment, and 25 of the 90 FDA approved biosimilars carried the designation as of January 2026. Non-interchangeable products still accounted for the largest share at 71.36% in 2025.
The report is careful on one point: interchangeable status widens access without setting share. Uptake still depends on cost, payer policy, formulary listing and prescribing practice, which is why manufacturers are building switching studies and payer engagement into development programs. More companies now consider interchangeability requirements earlier in development, which can aid future substitution opportunities. Formulary access matters because rebates can favor higher-priced products.
𝐁𝐫𝐨𝐰𝐬𝐞 𝐌𝐨𝐫𝐞 𝐈𝐧𝐬𝐢𝐠𝐡𝐭𝐬:
https://www.polarismarketresearch.com/industry-analysis/biosimilars-market
Adalimumab Biosimilars Show How Competition Plays Out
Adalimumab biosimilars offer the clearest view of a crowded market. As of January 2026, adalimumab counted 10 FDA approved biosimilars, and seven of the eight marketed products were reported as interchangeable. Adalimumab biosimilars held about 61.35% of the interchangeable segment in 2025. Boehringer Ingelheim (Cyltezo), Teva (Simlandi, marketed for Alvotech) and Fresenius Kabi (Idacio) compete in the molecule. TNF-alpha inhibitors held an estimated 14.72% share in 2025, used in conditions such as rheumatoid arthritis, psoriasis and inflammatory bowel disease, while autoimmune and inflammatory disorders as a whole held about 35.27%. Boehringer's unbranded adalimumab biosimilar was offered through GoodRx at USD 550 per two-pack at more than 70,000 US pharmacies, about 92% below Humira's list price.
Regional Snapshot
North America held a 34.68% share in 2025, and the FDA approved 18 biosimilars in 2025 alone. Europe accounted for 31.54%, supported by two decades of biosimilar approvals and tender-based procurement. Asia Pacific is projected to register the highest CAGR at 8.47% through 2036.
Key Players
Key players named in the report include Accord BioPharma Inc., Alvotech S.A., Amgen Inc., Amneal Pharmaceuticals, Inc., Biocon Biologics Ltd., Bio-Thera Solutions, Ltd., Boehringer Ingelheim International GmbH, Celltrion, Inc., Dr. Reddy's Laboratories Ltd., EirGenix, Inc., Formycon AG, Fresenius Kabi AG, mAbxience Holdings S.L., Organon & Co., Pfizer Inc., Samsung Bioepis Co., Ltd., Sandoz Group AG, Shanghai Henlius Biotech, Inc., Teva Pharmaceutical Industries Ltd. and Zydus Lifesciences Limited.
Conclusion
The Biosimilars Market is entering a cycle in which timing, regulation and access matter as much as science. Exclusivity milestones are pulling checkpoint inhibitor programs forward, and interchangeable designations are changing how products reach patients. Manufacturers and buyers that track clinical progress, formulary access and substitution rules will be best placed as the market moves toward USD 73.24 billion by 2036.
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