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 ...
Janet Woodcock, the acting commissioner of the US Food and Drug Administration (FDA), says there has been a “significant increase” in biosimilars approvals as the pharmaceutical industry has shown ...
One week after releasing its 11-part biosimilar action plan, the US Food and Drug Administration (FDA) announced it will hold a public hearing to gather input on how it can facilitate the development ...
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Shift in biosimilar commercial landscape essential for sector sustainability, expert says
While the regulatory landscape around biosimilars is evolving to encourage efficiency and innovation, the commercial ...
Tailored European Medicines Agency and FDA pathways may waive comparative efficacy studies when analytical and functional similarity are convincingly demonstrated, while preserving clinical ...
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 ...
SUNNYVALE, Calif.--(BUSINESS WIRE)--JSR Life Sciences, LLC (JSR) today announced the launch of a new business division, Similis Bio (Similis), which will operate a partnering program designed to help ...
Forbes contributors publish independent expert analyses and insights. Joshua Cohen is a Boston-based writer who covers health policy. Biosimilars are gradually making inroads in the outpatient drug ...
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