Biocon Pharma, a wholly owned subsidiary of Biocon, has received approval from the US Food and Drug Administration (US FDA) for its ANDA for tofacitinib extended-release tablets, securing final approval for the 11 mg strength and tentative approval for the 22 mg strength.   

Tofacitinib extended-release is a Janus kinase (JAK) inhibitor indicated for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis.

The approval further strengthens Biocon’s portfolio of vertically integrated, complex drug products.

Biocon delivered a strong performance in Q2 FY26, with operating revenue rising 20 percent year-on-year to INR 4,296 crore, driven by robust growth in biosimilars, improved traction in generics, and steady contributions from the CRDMO business.

The generics segment registered 24 percent growth, supported by increased uptake of recently launched products in the US and EU, growth of the generic formulations base business and and the API business.

A notable milestone during the quarter was the inauguration of Biocon’s first oral solid dosage (OSD) manufacturing facility in the United States, marking a major step in enhancing patient access to its vertically integrated product portfolio in the region. The company also initiated filings for Semaglutide (gOzempic) across several markets, including Canada and Brazil.