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News: Biologics Monographs is now a debated issue for USP and the FDA

On a recent issue of President Donald Trump's FY2020 budget request and a discussion draft circulated by the Senate Health, Education, Labor and Pensions (HELP) committee last month, the FDA and the USP are finding it difficult to reside in the court of the proposed law that will expunge the biosimilar products which requires it to stick to USP monographs.

The proposal, as per the FDA and USP is seen as a concern for lowering the drug costs and propagating various advancements in drugs that will encourage innovations. The FDA and USP have released a set of Q&A demanding a firm discussion with the Steven Kozlowski, director of the Office of Biotechnology Products at the Center for Drug Evaluation and Research (CDER), over the implementations of Monographs in the biosimilar products.