Navigating the Future of Rheumatology: The Role of Biosimilars and CAR-T Therapy

Navigating the complex landscape of rheumatology therapeutics reveals a dual frontier of innovation: the burgeoning influence of biosimilars and the groundbreaking potential of CAR-T therapy. Both avenues are reshaping therapeutic strategies and cost paradigms in patients with autoimmune diseases, though biosimilars have demonstrated real‑world impact while CAR‑T remains investigational in autoimmunity as reflected across major meeting reports and reviews.

With a focus on cost reduction and broader patient access, biosimilars are progressively transforming the rheumatology therapeutics market. As shown in the EULAR 2023 data on rheumatology biosimilars, approved biosimilars like infliximab have demonstrated no clinically meaningful differences in efficacy and safety compared with their reference products—at lower costs—supporting adoption (including in switching contexts) and amplifying market growth.

Despite robust evidence supporting no clinically meaningful differences from reference biologics, integrating biosimilars into mainstream treatment is impeded by regulatory and reimbursement barriers. These factors create hesitancy among providers, as detailed by the JCO 2025 analysis, and are echoed in rheumatology policy discussions around interchangeability and switching.

Early studies of CAR‑T therapy in autoimmune diseases such as lupus suggest potential benefit through targeted depletion of pathogenic B cells, but this approach remains investigational and is not yet endorsed for routine care. The J Rheum 2025 report underscores signal findings in symptom reduction and remission in small cohorts.

If biosimilars exemplify a maturing evidence and policy ecosystem, CAR‑T represents the frontier: ongoing early‑phase trials are exploring its use in autoimmune disease. The Clinical Trials 2024 overview highlights precision targeting of B cells and exploratory endpoints in small cohorts, with implications for future rheumatology treatments.

Key Takeaways:

• Biosimilars are key to expanding access to biologic therapies while managing costs.
• Regulatory and reimbursement challenges continue to impact the adoption of biosimilars.
• CAR‑T therapy is an emerging investigational approach for autoimmune diseases, with early promise in lupus.
• Clinical trials illustrate the evolving landscape of immunotherapy interventions.