HYDERABAD — Dr. Reddy's Laboratories confirmed on Tuesday that its rituximab biosimilar had secured approval from the US Food and Drug Administration, clearing the way for a US launch of the cancer and autoimmune therapy.

Rituximab is used to treat non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis and several autoimmune conditions. The original reference product, marketed as Rituxan by Genentech and MabThera by Roche, generated billions of dollars in annual sales before patent expiry opened the market to biosimilar competitors.

The company described the clearance as a milestone in its expanding global biosimilars business. The approval adds to a portfolio that Dr. Reddy's has said it intends to grow across regulated markets in the United States and Europe. Company filings have described biosimilars as a core pillar of its strategy to offset pricing pressure in its generic drugs division.

US biosimilar launches typically face intense price competition from established rivals such as Amgen, Pfizer and Teva. A successful commercial rollout would depend on manufacturing scale, payer coverage and interchangeability decisions that shape uptake among American prescribers.

A Dr. Reddy's spokesperson said the approval reinforced the company's commitment to increasing patient access to affordable biologic medicines, and that commercial availability in the United States would follow standard launch planning.