Key Highlights:
- Dr. Reddy’s Laboratories has received CDSCO approval to manufacture and market its abatacept biosimilar in India for adults with moderate-to-severe active rheumatoid arthritis and active psoriatic arthritis who have responded inadequately to other disease-modifying antirheumatic drugs.
- The approval covers both the finished formulation and active pharmaceutical ingredient, with manufacturing planned at Dr. Reddy’s biologics facility in Bachupally. The company has also partnered with Gland Pharma for supply. The approval is conditional on a Phase IV study in India, with the protocol due within three months.
- The biosimilar offers an alternative to Bristol Myers Squibb’s Orencia (abatacept), which generated $3.9 billion in 2025. Dr. Reddy’s is also awaiting U.S. FDA review of its abatacept biosimilar, with a target action date set for December 2026.
Implications:
Dr. Reddy’s has secured CDSCO approval for its abatacept biosimilar (250 mg IV) for adults with moderate‑to‑severe active rheumatoid arthritis and active psoriatic arthritis who failed other DMARDs, with manufacturing at its Bachupally biologics facility and supply support from Gland Pharma. The approval is conditional on a Phase IV study (protocol due within 3 months) and positions Dr. Reddy’s to compete with Orencia (global 2025 sales ~$3.9B) in India, while the company awaits a U.S. FDA decision with a December 2026 target action date.
Source: ET Pharma
