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Jun 25, 2014

Is an Abbreviated Pathway for Biosimilars Coming Soon to China?

Presently, no abbreviated pathway is available in China for biosimilars. Accordingly, any biopharmaceutical drug (biologic or biosimilar) must be filed as a new drug application. A new drug application takes anywhere from five to ten years and costs from one to ten million U.S. dollars. However, industry insiders are reporting that guidelines establishing a biosimilar pathway […]
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