China Publishes Draft Guidelines for Biosimilars

In a long-awaited move, China's Center for Drug Evaluation has published draft regulations for approval of biosimilar drugs. The proposed rules offer the possibility of a shorter regulatory timeframe for this very important class of drugs, though the proposals, which are more like an overview than a how-to manual, are not specific. They do, however, establish a step-by-step procedure in which "no or little difference" in one test could mean fewer or smaller tests in subsequent steps, which seems to give regulators significant discretionary power. To be approved, a biosimilar must undergo a randomized, double-blind clinical trial to prove efficacy. More details....

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