Biologic medicines have transformed modern healthcare, but their high cost continues to limit access for many patients worldwide. Biosimilars – biologic therapies shown to be highly similar to existing reference products – offer a powerful solution by introducing competition and reducing drug prices. Their adoption is already reshaping treatment landscapes, with proven cost savings and expanded patient access in key therapeutic areas. As regulatory frameworks evolve, biosimilars are positioned to play an even greater role in global healthcare.
How Biosimilars Improve Access to Lifesaving Treatments?
The key promise of biosimilars lies in cost reduction and competition. By offering biologic therapies at lower prices, biosimilars can help health systems deliver therapies to more patients, especially in settings where cost is a limiting factor.
Several real-world examples underscore these benefits. In the U.S., biosimilar adoption in certain classes has already led to 20–30% cost reductions versus reference biologics, according to recent reviews. [1]
Moreover, as more high-value biologics (e.g. monoclonal antibodies) lose patent protection, the biosimilars pipeline becomes increasingly rich. In 2024, the U.S. FDA approved 18 biosimilars signaling intensifying momentum. [2]
Still, access gains are not uniform globally. Variability in regulatory frameworks, market incentives, reimbursement policies, and provider/physician acceptance can slow uptake in certain jurisdictions.
Economic Impact of Biosimilars on Healthcare Systems
The introduction of biosimilars carries significant economic ramifications for public and private payors. Lower-priced biosimilars reduce drug spend, freeing resources for other therapies or health priorities. Some projections suggest multi-billion USD cumulative savings over a decade in mature markets.
High costs of biosimilar development must be balanced by market penetration and reimbursement incentives. Biosimilars can spur price competition, forcing originator biologics to discount or innovate.
In the U.S., the biosimilars market is projected to reach about $10 billion by 2028. Despite this, uptake of some biosimilars (https://www.mabion.eu/science-hub/articles/end-to-end-manufacturing-of-biosimilars/) has lagged, particularly in high-competition reference biologics markets (e.g. Humira), where the originator has retained dominant market share in part due to legal, patent, or prescriber barriers. [3]
Ensuring Quality, Safety, and Efficacy of Biosimilars
Because biosimilars stem from biologic systems, small manufacturing changes can lead to differences in glycosylation, folding, post-translational modifications, aggregation, or immunogenicity. Thus, their development is more akin to developing a new biologic than a traditional generic small molecule.
The foundation is highly sensitive physicochemical and structural characterization using mass spectrometry (https://www.mabion.eu/science-hub/articles/mass-spectrometry-in-peptide-and-protein-analysis/), chromatography and high-resolution methods to confirm that the biosimilar and the reference product are “highly similar.” Functional assays (binding, cell-based bioactivity) are also essential to confirm biological activity. Some regulatory agencies now permit waiver of certain clinical trials if robust analytical and functional comparability is established. [4]
Comparative toxicology, pharmacodynamics, immunogenicity risk assessment, and animal bridging studies may be required depending on residual uncertainty. Some jurisdictions increasingly allow in vitro or mechanistic data in place of extensive in vivo studies. Comparative PK/PD studies in humans are usually required to confirm similar exposure and response. Adaptive or seamless trial designs (incorporating PK and efficacy stages) can help reduce time and sample size. If residual uncertainty remains, comparative efficacy studies (e.g. noninferiority or equivalence) in a sensitive patient population may be required. Extrapolation to other indications (i.e. approving the biosimilar for all reference product indications) is often possible if scientific justification is provided. [1,5]
The manufacturing process must be tightly controlled; process changes must undergo comparability assessments. CMC documentation must justify that each batch is comparable to the reference, maintaining purity, potency, and impurity profiles. [1]
One promising technological enabler is and data-driven process control. This approach include real-time monitoring, predictive modeling, and advanced process analytics (check more: https://www.mabion.eu/analytics/) can help tighten process windows, reduce failure risk, and enable “quality by design” for biologics manufacturing.
Because of these demands, biosimilar development timelines are often 7-10 years, and costs may be 10-20% of a novel biologic development (but still much higher than small-molecule generics).
Regulatory Pathways Supporting Biosimilar Adoption
Regulatory frameworks are crucial to creating a predictable, transparent environment for biosimilar development. The European Medicines Agency (EMA) pioneered the concept of biosimilars and remains a benchmark. The U.S. Food and Drug Administration (FDA) pathway under BPCIA (351(k)) is another prominent model. The World Health Organization (WHO) provides guiding frameworks useful for low- and middle-income countries. Many national agencies (e.g. India’s CDSCO) adopt or adapt these guidelines.
In the U.S., interchangeability is a higher designation (beyond biosimilarity) that permits pharmacy-level substitution, subject to switching studies (though FDA has proposed removing the switching-study requirement). Biosimilars Action Plan lays out strategies to accelerate and improve biosimilar competition and clarity. Some jurisdictions permit automatic substitution; others restrict it. Policies regarding substitution strongly affect uptake. [4]
Differences in requirements (e.g. study expectations, naming, naming of biosimilars, interchangeability rules) across jurisdictions pose challenges for multinational development. Efforts toward convergence or reliance frameworks (e.g. regulators accepting data from trusted agencies) are ongoing. Biologics (including biosimilars) require ongoing monitoring for immune responses, rare adverse events, and effectiveness in real-world settings. Regulatory guidelines often mandate risk-management plans, registries, and periodic safety reporting. [6]
Future Outlook for Biosimilars in Global Healthcare
The biosimilars landscape is currently undergoing a notable regulatory shift, and these changes are poised to accelerate innovation, reduce barriers to entry, and broaden global access. One of the most consequential recent developments is regulatory authorities’ increasing willingness to waive or scale back traditional comparative clinical efficacy studies when scientific justification is robust.
The EMA has proposed a more streamlined approach in its recent draft reflection paper, suggesting that structural and functional comparability together with pharmacokinetic/pharmacodynamic (PK/PD) data may suffice to establish biosimilarity. That is potentially eliminating or reducing the need for large confirmatory efficacy trials. EMA’s reflection paper builds on a prior concept paper advocating a tailored clinical approach, which questions whether certain in vivo nonclinical or efficacy endpoints are still necessary when the analytical data is strong. The EMA approach aims to maintain high standards of safety and efficacy while reducing redundant trials, thereby lowering cost and shortening development time. [7]
In the U.S., a watershed moment occurred with the first-ever FDA waiver of clinical efficacy studies for a monoclonal antibody biosimilar. The FDA granted a waiver of clinical efficacy (comparative) trials for a biosimilar of ustekinumab (Stelara), marking a historic precedent. The agency’s decision reflects evolving confidence in advanced analytical, functional, and immunogenicity testing to reliably predict clinical behavior, thereby deemphasizing redundant patient trials. Proponents estimate that such waivers could reduce development costs by over 90% and cut approval timelines by more than 70%, opening the door for more agile competition and innovation. This precedent may encourage further FDA flexibility for other biologic classes or therapeutic modalities. [8]
Together, these moves mark a shift toward analytics-first, clinical-if-needed regulatory strategies. As regulators gain more confidence in state-of-the-art characterization tools, the reliance on costly and time-consuming clinical efficacy trials may increasingly be viewed as redundant when the totality of evidence strongly supports biosimilarity.
In many low- and middle-income countries, biosimilars can play a transformational role in expanding access to biologics where originators remain prohibitively expensive. Regulatory capacity building, reliance on WHO guidelines, and local manufacturing partnerships are promising strategies. In summary, biosimilars are poised to play a growing role in global healthcare, offering a pathway toward more equitable access to biologic therapies. The successful expansion of biosimilars will hinge on innovation in manufacturing, regulatory collaboration, intelligent market strategies, and stakeholder trust.
References
- Monga A, Gagan, Jamwal P, Sharma S, Kaur A. Biosimilars: A Critical Review of Development, Regulatory Landscape, and Clinical Implications. AAPS PharmSciTech. 2025 Jan 27;26(1):46. doi: 10.1208/s12249-025-03038-2.
- Center for Drug Evaluation and Research. Advancing Health Through Innovation: New Drug Therapy Approvals 2024. U.S. Food and Drug Administration. Silver Spring, MD: 2025.
- Sunny M, Satija B. US FDA proposes to remove switching study requirement for biosimilars. Reuters. 2024.
- Car E, Barbier L, Huys I, Simoens S, Vulto AG. Evolving global regulatory landscape for approval of biosimilars: current challenges and opportunities for convergence. Expert Opin Biol Ther. 2025 Jun;25(6):649-668. doi: 10.1080/14712598.2025.2507832.
- Sinha S, Raphael R. Developing Biosimilars: Challenges and Opportunities. Pharmaceut Med. 2025 Sep;39(5):341-352. doi: 10.1007/s40290-025-00578-7.
- Knox RP, Desai V, Sarpatwari A. Biosimilar approval pathways: comparing the roles of five medicines regulators. J Law Biosci. 2024 Sep 13;11(2):lsae020. doi: 10.1093/jlb/lsae020.
- Tuszyner A. The New Era of Biosimilar Development: Seizing the Opportunity Under EMA’s Streamlined Guidelines. Mabion Science Hub. 2025.
- Pharmaceutical Scientist. Professor Sarfaraz K. Niazi Secures First-Ever FDA Acceptance to Waive Clinical Efficacy Studies for Monoclonal Antibody Biosimilars. BioSpace. 2025.
