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International Regulators Explain Work-Sharing Scheme For Biosimilars

Follows Pilot Launched Earlier This Year

 
• By Vibha Sharma

New guidance from the ACCESS Consortium of regulators from five countries explains how biosimilar drug sponsors can apply for an internationally-coordinated review of new products.

Businessman handshake on mou - memorandum of understanding with legal document contract papers after agreement.
The Access Consortium relies on confidentiality agreements and memoranda of understanding to coordinate reviews • Source: Alamy

Regulators participating in the ACCESS Consortium, an international work-sharing scheme to accelerate drug approvals, have issued guidance to support a pilot they launched earlier this year for assessing marketing applications for new biosimilar medicines.

The biosimilars work-sharing initiative (BSWSI) builds on the success of two of the consortium’s ongoing initiatives covering new active substances (NASs) and generic medicines respectively. The NASs initiative has already resulted in the marketing approval of several drugs after they were jointly evaluated under the work-sharing program

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