Saudi Arabia publishes biosimilars regulation

The Kingdom of Saudi Arabia's Saudi Food and Drug Authority has published a first draft of its drug master file requirements for the registration of biosimilars. In its present form, the 10-page document lists the administrative, technical and scientific information standards for a biosimilar application to the regulator.

There are also proposals for requirements concerning clinical studies, which involve comparison with the reference product, a pharmacovigilance plan and other documentation and necessary information. The draft is available for comments and suggestions, which should be sent to the SFDA's Drug Sector: PO Box 84983 Riyadh 11681, Saudi Arabia. E-mail address: Drug-Dept@sfda.gov.sa.