The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to streamline and expedite the biosimilar development process.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 ...
The European Medicines Agency (EMA) reports on progress to create a smoother, less wasteful biosimilar development process; and the World Health Organization (WHO) revises its biosimilar development ...
In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work ...
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 ...
In this week’s edition of InnovationRx, we look at cheaper biologic drugs, Novo Nordisk’s $2 billion next-gen obesity drug deal, new ways of fighting cancer, and more.
The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...
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