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 ...
The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to streamline and expedite the biosimilar development process. The regulatory framework has been designed to reduce ...
Owen Hosseinzadeh, Maarika Kimbrell, Christina Macdougall, Ph.d. FDA recently issued a new draft guidance titled Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: ...
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 ...
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 ...
The FDA's draft guidance could streamline biosimilar approval by reducing the need for comparative efficacy studies, emphasizing analytical assessments instead. This approach may lower development ...
Samsung Bioepis has released its Second Quarter 2025 Biosimilar Market Report, which provides the second quarter 2025 Average Sales Price and Wholesale Acquisition Cost of the commercially available ...
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