CDSCO approves Dr Reddy’s abatacept biosimilar for rheumatoid and psoriatic arthritis in India

The conditional marketing approval introduces a new intravenous abatacept biosimilar for patients with moderate to severe rheumatoid arthritis or active psoriatic arthritis who have responded inadequately to other disease-modifying treatments.

India’s Central Drugs Standard Control Organisation (CDSCO) has granted Dr Reddy’s Laboratories approval to manufacture and market its abatacept biosimilar 250 mg intravenous formulation for moderate to severe active rheumatoid arthritis and active psoriatic arthritis in patients with an inadequate response to other disease-modifying antirheumatic drugs.

The approval adds a biosimilar alternative to reference abatacept, while requiring Dr Reddy’s to conduct a Phase IV study in India and submit the study protocol within three months.

Field	Content
Alert Type	Drug Approval
Drug Name	Dr Reddy’s abatacept biosimilar, 250 mg intravenous formulation
Indication	Treatment of moderate to severe active rheumatoid arthritis and active psoriatic arthritis in patients who have responded inadequately to other disease-modifying antirheumatic drugs. (pharma.economictimes.indiatimes.com)
Therapy Area(s)	Rheumatology; Immunology
Geography	India (CDSCO)
What Happened	India’s central licensing authority, CDSCO, has approved Dr Reddy’s Laboratories to manufacture and market its 250 mg intravenous abatacept biosimilar for moderate to severe active rheumatoid arthritis and active psoriatic arthritis following inadequate response to other disease-modifying antirheumatic drugs. The company secured approval for both the finished formulation and active pharmaceutical ingredient, with manufacturing at its Bachupally biologics facility. The marketing authorisation is conditional on a Phase IV study in India, with Dr Reddy’s required to submit the trial protocol within three months. CDSCO records also show clinical development of a subcutaneous abatacept presentation, but the current marketing approval concerns the 250 mg IV formulation. (pharma.economictimes.indiatimes.com)
Why It Matters	Abatacept provides a biologic treatment option for patients with rheumatoid or psoriatic arthritis whose disease has not responded adequately to other disease-modifying therapies. Approval of a biosimilar introduces an additional abatacept option in India, although the regulatory decision alone does not establish its pricing, availability, uptake or comparative access relative to the reference medicine. (pharma.economictimes.indiatimes.com)
Supporting Context	Abatacept is a fusion protein that modulates T-cell activation by interfering with the CD80/CD86 and CD28 co-stimulatory pathway. Dr Reddy’s has also been developing intravenous and subcutaneous abatacept presentations for other markets; its US biologics licence application for the IV presentation was submitted in December 2025. (pharma.economictimes.indiatimes.com)
Key Takeaway	CDSCO approval gives Dr Reddy’s a 250 mg intravenous abatacept biosimilar for the Indian rheumatoid and psoriatic arthritis market, subject to a post-marketing Phase IV study. (pharma.economictimes.indiatimes.com)
What to Watch	Submission and subsequent conduct of the required Indian Phase IV study, commercial launch of the IV biosimilar, and regulatory progress for Dr Reddy’s abatacept programme in other markets, including the United States. (pharma.economictimes.indiatimes.com)
Primary Source	Central Drugs Standard Control Organisation (CDSCO)
Relevant Date	25 August 2026

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