Biosimilar drugs gain ground in US market with new approvals and market leadership

The US biosimilar market is expanding with new approvals and shifting market leadership. Celltrion's Truxima became the first Korean biosimilar to lead its US segment, capturing a 35.8% prescription share by February 2026. Meanwhile, Biocon launched its FDA-approved denosumab biosimilars, Bosaya and Aukelso, nationwide on April 7, 2026. Additionally, the FDA approved Lupin's Ranluspec on June 2, 2026, as the first interchangeable ranibizumab biosimilar in both vial and syringe presentations.

FDA interchangeable biosimilar approvals

• ▪The US Food and Drug Administration approved Lupin Limited's Ranluspec on June 2, 2026, as the first interchangeable ranibizumab biosimilar available in both single-dose vial and prefilled syringe presentations
• ▪Ranluspec is the fourth interchangeable ranibizumab biosimilar approved in the United States, following Byooviz in 2021, Cimerli in 2022, and Nufymco in late 2025
• ▪The US Food and Drug Administration granted interchangeable designations to Biocon Limited's Bosaya and Aukelso denosumab biosimilars in September 2025

Celltrion Truxima market leadership

• ▪Celltrion launched Truxima in the United States in November 2019, reaching the top prescription spot approximately six years and three months after its initial launch
• ▪Celltrion's rituximab biosimilar Truxima achieved a 35.8 percent prescription share in the United States as of February 2026, becoming the first Korean biosimilar to top its segment in the US market
• ▪Celltrion's Truxima recorded over 300 billion won ($198 million) in North American sales in 2025, representing an approximate 40 percent increase from its 2024 sales

Biocon denosumab biosimilar launch

• ▪Biocon Limited announced the commercial launch of its prescription medications Bosaya and Aukelso, which are biosimilars of the drug Denosumab, in the United States on April 7, 2026
• ▪Biocon Limited's Bosaya and Aukelso are distributed nationwide through specialty pharmacies and healthcare providers to treat osteoporosis and bone complications
• ▪Denosumab products, which treat osteoporosis and bone complications associated with cancer, generated approximately $5 billion in United States sales in 2024

Biosimilar pricing strategies

• ▪Lupin Limited has not yet disclosed the planned United States launch date or the list price for its ranibizumab biosimilar Ranluspec
• ▪Celltrion projected expanded business opportunities in the United States after the US government excluded biosimilars from its tariffs

Therapeutic indications for biosimilars

• ▪Biocon Limited's Bosaya and Aukelso are expected to benefit approximately 10 million US adults with osteoporosis and over 330,000 patients annually with bone metastasis
• ▪Celltrion's Truxima is prescribed as a rituximab biosimilar for the treatment of blood cancer
• ▪Lupin Limited's Ranluspec is indicated for five retinal conditions, including wet age-related macular degeneration, which affects an estimated 1.7 million Americans

Clinical equivalence demonstration

• ▪Under the Biologics Price Competition and Innovation Act, the interchangeable designation allows pharmacists to substitute Lupin Limited's Ranluspec for Lucentis without prescriber intervention, subject to state laws
• ▪The US Food and Drug Administration's approval of Lupin Limited's Ranluspec was based on data demonstrating no clinically meaningful differences in safety, purity, potency, pharmacokinetics, pharmacodynamics, or immunogenicity compared to Lucentis