Dr. Reddy’s Laboratories announced that the U.S. Food and Drug Administration has accepted its Biologics License Application for a proposed interchangeable biosimilar of abatacept, a biologic used to treat rheumatoid arthritis and other autoimmune conditions. The acceptance, announced on February 20, 2026, marks a critical regulatory milestone that moves the candidate closer to potential market entry in the United States.
Abatacept, sold under the brand name Orencia, generated $2.77 billion in U.S. sales for Bristol‑Myers Squibb in 2025. The biosimilar market is projected to exceed $100 billion globally by 2030, with the U.S. segment expected to surpass $31 billion in the same period. An interchangeable designation allows pharmacy‑level substitution without prescriber intervention, potentially accelerating adoption and expanding patient access to a cost‑effective alternative.
Dr. Reddy’s has been expanding its biosimilar pipeline while shifting toward high‑margin innovation platforms such as GLP‑1 therapies and consumer‑health products. The abatacept BLA acceptance is the first step in a broader strategy to diversify beyond traditional generics and capture growth in the rapidly expanding biosimilar market.
CEO Milan Kalawadia said, “We are proud to be the first to submit a BLA for an abatacept biosimilar which marks a significant milestone in our mission to increase patient access to critical, high‑quality biologic therapies.” He added, “We look forward to working with the FDA to bring this in‑house developed biosimilar to market as a cost‑effective alternative for patients and healthcare providers in the United States.”
The FDA’s acceptance is the initial phase of a multi‑year review process that typically takes 12–18 months for an interchangeable biosimilar. Dr. Reddy’s is the first company to submit a BLA for abatacept, but other firms, including a few specialty biologic manufacturers, are also developing abatacept biosimilars, creating a competitive landscape that will shape pricing and market share once approvals are granted.
The biosimilar’s potential to reduce treatment costs for rheumatoid arthritis, psoriatic arthritis, and juvenile idiopathic arthritis could position Dr. Reddy’s as a key player in a market that is expected to grow rapidly. The company’s focus on high‑margin innovation, combined with the regulatory progress on this product, signals a strategic shift that could enhance long‑term profitability and broaden its therapeutic portfolio.
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