India Pharma Outlook Team | Wednesday, 26 August 2026
Dr Reddy’s Laboratories has secured a key approval for its arthritis treatment portfolio in India. The company received marketing approval for its abatacept biosimilar from the Central Drugs Standard Control Organisation (CDSCO).
The approval covers patients with moderate to severe active rheumatoid arthritis. It also covers active psoriatic arthritis in patients who did not respond adequately to other disease-modifying drugs.
The approval could strengthen Dr Reddy’s position in the Indian biosimilars market. The company is also looking to expand its presence in global markets.
CDSCO has approved Dr Reddy’s abatacept biosimilar for marketing in India. The approval comes with a requirement to conduct a Phase IV study in the country. The company must submit the Phase IV trial protocol within three months. Dr Reddy’s has received approval for both the finished formulation and the active pharmaceutical ingredient.
The company will manufacture the drug at its biologics facility in Bachupally, India. It has also partnered with Gland Pharma to support the drug’s supply. The approved product is the 250 mg intravenous formulation. Dr Reddy’s had earlier evaluated both intravenous and subcutaneous versions of abatacept.
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Abatacept is a fusion protein that works by reducing T-cell activation. T-cells are a type of white blood cell involved in immune responses. The drug blocks the interaction between CD80/CD86 and CD28. This helps reduce the immune response linked to inflammation.
As a result, abatacept can help reduce joint pain, swelling and inflammation. These symptoms are common in autoimmune inflammatory conditions. The biosimilar is designed as an alternative to Bristol Myers Squibb’s Orencia. Orencia generated $3.9 billion in revenue during 2025, according to the report.
Dr Reddy’s approval could therefore create a new opportunity in the arthritis treatment market.
The Hyderabad-based company is also awaiting a decision from the US FDA on its abatacept biosimilar. The application is currently under review, with a target action date set for December. The company submitted its US application for DRL_AB in December 2025. The US application covers the IV infusion formulation.
If approved, the product could target rheumatoid arthritis and psoriatic arthritis. It could also cover polyarticular juvenile idiopathic arthritis in children aged six years and older. Dr Reddy’s expects the product to support growth in its US business. Investors are watching the approval closely for its potential commercial impact.
The company’s recent regulatory progress also follows approval of its cancer drug rituximab. Both products were filed from the Bachupally facility.
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