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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.

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