Biosimilars in Autoimmune and Inflammatory Diseases

Autoimmune and inflammatory diseases such as rheumatoid arthritis, psoriasis and inflammatory bowel disease represent a substantial burden on global health and healthcare budgets. Biological therapies targeting tumour necrosis factor, interleukins and other immune mediators have transformed disease management but often carry high costs and access barriers. Biosimilars – biotherapeutic agents developed to be highly similar to licensed reference biologics – have emerged as cost-effective alternatives, offering equivalent efficacy, safety and immunogenicity profiles. Their approval relies on a totality-of-evidence approach encompassing advanced structural and functional analytics, comparative non-clinical assessments, and concise clinical trials that collectively demonstrate no clinically meaningful differences to the originator product. Regulatory pathways permit indication extrapolation, facilitating rapid expansion of treatment options across multiple immune-mediated conditions. Post-marketing pharmacovigilance and real-world evidence have further consolidated the safety and effectiveness of biosimilars, informing best practices for switching and interchangeability while addressing nocebo phenomena. Strategic policy incentives and educational initiatives directed at clinicians, pharmacists and patients are critical to overcoming residual hesitancy and achieving sustainable biosimilar uptake. By expanding patient access, reducing inequities in treatment availability and fostering competitive biologics markets, biosimilars are poised to reshape therapeutic paradigms and support healthcare systems under financial constraints.

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Biosimilars in Autoimmune and Inflammatory Diseases publication trend

The graph below shows the total number of articles in biosimilars in autoimmune and inflammatory diseases across all publications each year (not limited to Nature Index journals).

Technical terms

Biosimilar: A biotherapeutic product highly similar to an already approved reference biologic, with no clinically meaningful differences in quality, safety or efficacy.

Immunogenicity: The propensity of a biotherapeutic to elicit an immune response, typically assessed by the formation of antidrug antibodies.

Monoclonal antibody: A laboratory-engineered protein that binds with high specificity to a target antigen, commonly used in the treatment of autoimmune and inflammatory conditions.

Extrapolation: A regulatory mechanism allowing approval of a biosimilar for multiple indications of the reference product without conducting separate clinical trials for each condition.

Interchangeability: A designation permitting substitution of a biosimilar for its reference product without prescriber intervention, subject to local regulatory approval.

References

1. A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Arthritis Research & Therapy (2016).
2. Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study. Arthritis Research & Therapy (2016).
3. The EGALITY study: a confirmatory, randomized, double‐blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate‐to‐severe chronic plaque‐type psoriasis. British Journal of Dermatology (2017).
4. Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: results from the phase III randomised VOLTAIRE-RA equivalence study. Annals of the Rheumatic Diseases (2018).
5. The nocebo effect challenges the non-medical infliximab switch in practice. European Journal of Clinical Pharmacology (2018).
6. Switching Between Reference Biologics and Biosimilars for the Treatment of Rheumatology, Gastroenterology, and Dermatology Inflammatory Conditions: Considerations for the Clinician. Current Rheumatology Reports (2017).
7. Policies for biosimilar uptake in Europe: An overview. PLOS ONE (2017).
8. Key drivers for market penetration of biosimilars in Europe. Journal of Market Access & Health Policy (2017).
9. Biological Therapies in Immune-Mediated Inflammatory Diseases: Can Biosimilars Reduce Access Inequities?. Frontiers in Pharmacology (2019).
10. Biosimilars: Key regulatory considerations and similarity assessment tools. Biotechnology and Bioengineering (2017).