Results from a prospective, multicentre study have answered the unmet medical need for a cost‑effective biosimilar alternative for managing active Rheumatoid Arthritis (RA) by evaluating the clinical comparability between biosimilar adalimumab and innovator product among Indian patients with active Rheumatoid arthritis.

In the management of rheumatoid arthritis (RA), the efficacy of adalimumab has been well established. It improves disease activity, quality of life, and prevents structural deterioration and disability. Combination of methotrexate (MTX) and adalimumab also has been extensively evaluated and the combination improves the symptoms compared in patients with RA who had a partial response to MTX.

Biosimilar adalimumab products are developed, which are similar to licensed reference product. Biosimilar adalimumab has similar safety, purity, and potency and no clinically significant differences exist compared with the reference product.

However, a prospective, multicentre, randomised, double‑blind, two‑arm, parallel group, active‑control, comparative clinical study was conducted to validate the clinical efficacy and safety of the biosimilar adalimumab with the reference (innovator) adalimumab in patients with moderate‑to‑severe RA who were on stable dose of MTX.