For companies developing interchangeable biosimilars, the FDA guidance opens the door to more tailored, risk-based programs that may reduce reliance on costly comparative efficacy studies (CES). For ...
Michael Ellenberger, Aydin Harston Ph.D. On October 29, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS) and the Centers for ...
An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
Ten years after the first biosimilar launched on the U.S. market, the FDA is taking steps to make biosimilar development and pharmacy substitution more like that of generics, reducing the cost of the ...
The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...
The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...
Owen Hosseinzadeh, Maarika Kimbrell, Christina Macdougall, Ph.d. FDA recently issued a new draft guidance titled Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: ...
Please provide your email address to receive an email when new articles are posted on . The FDA issued draft guidance that would streamline testing of biosimilars. A separate plan would eliminate ...
Patent expirations are usually regarded as the pivot points where IP protection ends and competition begins, impacting drug pricing. As off-patent products enter the market with lower prices, the ...
Panelists discuss how the Inflation Reduction Act (IRA) of 2022 has influenced biosimilar utilization in the US health care system through its pharmacy provisions targeting Medicare patients, ...
The global biosimilar monoclonal antibody market revenue was around US$ 10.6 billion in 2023 and is estimated to reach US$ 64.7 billion by 2032, growing at a compound annual growth rate (CAGR) of 22.2 ...
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