FDA Withdraws Its Pivotal Biosimilar Products Testing Guideline After Sarfaraz Niazi, Founder of Pharmaceutical Scientist, Files the First Citizen Petition Challenging Its Clinical Relevancece

In an unprecedented move, the US FDA withdrew its guidelines on the approval of biosimilar products, a multi billion dollar marketplace, after Niazi filed a citizen petition identifying the flaws in the scientific strategies of the guideline. This change will allow faster entry of biosimilars to the market and make them more accessible.
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