FDA Plans to Ease Biosimilar Testing Requirements as Market Expands
The FDA is expected to issue draft guidance reducing testing requirements for biosimilar drugs, potentially lowering development costs by USD 20 million. The move comes as the biosimilars market shows strong growth, with major launches in 2025.
The U.S. Food and Drug Administration plans to ease testing requirements for companies developing biosimilar drugs, according to an agency official and internal documents. The FDA is expected to issue draft guidance as soon as Monday that would reduce the need for certain studies used to show that biosimilar medicines match the brand-name treatments they are based on.
Unlike cheap generic versions of simple-to-manufacture pills, medicines made from living cells cannot be exactly copied, so are referred to as biosimilars. The policy is part of a broader FDA effort to make it easier for companies to win approval for such drugs.
The biosimilars market demonstrated strong performance in 2025, with Sandoz reporting biosimilar sales up by 13% at constant currencies for the full year and by 18% at comparable growth rate. The biosimilar share of Sandoz's total net sales increased to 30% in FY 2025 from 28% in FY 2024. Sandoz achieved full-year 2025 net sales of USD 11.1 billion, up by 5% at constant currencies and 7% in USD, with biosimilar sales reaching USD 3,292 million compared to USD 2,853 million in 2024.
Major biosimilar launches in 2025 included Pyzchiva (ustekinumab), which was launched in the US in February 2025, offering new treatment options for around 12 million patients with chronic inflammatory diseases such as psoriasis and psoriatic arthritis. The rollout included a full suite of dosing options and extended stability compared to the reference medicine. The Pyzchiva autoinjector was launched in Europe in May 2025, the first ustekinumab biosimilar in Europe available in a pre-filled pen.
Wyost and Jubbonti (denosumab) were launched in the US in June 2025 as the first FDA-approved interchangeable denosumab biosimilars, providing affordable treatment options for osteoporosis and cancer-related skeletal events. In June 2025, Amgen received FDA approval for its interchangeable biosimilar to Humira (adalimumab), marking a major competitive milestone and expanding patient access to a high-volume biologic through lower-cost options.
The Biosimilars and Biologics Market reached US$ 531.45 billion in 2024 and is expected to grow to around US$ 1,773.77 billion by 2033, expanding with a CAGR of approximately 14.4% from 2025 to 2033 as demand for advanced therapeutic biologics and lower-cost biosimilar alternatives rises globally. Growth is supported by increasing demand across key segments such as monoclonal antibody therapies, recombinant proteins, vaccines, and other biological treatments used in oncology, autoimmune disorders, chronic diseases, and rare conditions.
In March 2025, the FDA finalized updated guidance to streamline biosimilar approvals and clarify interchangeability requirements, aiming to reduce review times and increase market competition. In September 2025, UnitedHealth Group expanded its biosimilar pharmacy incentive programs, encouraging greater use of biosimilars in employer and Medicare Advantage plans to cut drug spend while maintaining clinical outcomes.
In Europe, the European Medicines Agency adopted updated regulatory scientific recommendations on extrapolation and immunogenicity assessment for biosimilar approvals in July 2025, helping harmonize pan-EU pathways. Multiple biosimilar launches occurred across Europe in May 2025 for key oncology and autoimmune biologics including infliximab and rituximab variants, expanding treatment options and improving price competition.