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RDPAC Calls For Chinese Post-marketing Surveillance For Biosimilars – Peking University Symposium

 
• By Brian Yang

China has yet to issue a clear regulatory pathway for biosimilars approvals. The existing, lower standard pathway has the branded industry calling for vigorous post-marketing measures to ensure safety.

BEIJING – China FDA is preparing its first biosimilars guidelines. The newly reorganized agency has been tight-lipped about approval requirements, but industry experts are calling for enhanced post-marketing surveillance.

“[Post-marketing surveillance is] critical for patient safety, especially in identifying immunogenicity and increasingly important when biosimilars are used,” said Joseph Cho, managing director of the R&D-based Pharmaceutical Association Committee (RDPAC), during a July 5

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