IL Biosimilar Update: New MOH Guidelines Facilitate Registration of Biosimilars

The updated Biosimilar Registration Guidelines of the Israeli Ministry of Health (“Procedure 127”) will enter into force on July 15th, 2023. The updated Guidelines are intended to facilitate registration of biosimilar products and the switching to biosimilar products from the reference product.

According to the updated Guidelines, a biosimilar product submitted for approval in Israel must already be registered in one of the following jurisdictions: EU (Centralized, Decentralized or Mutual Recognition Procedures), UK, US, Canada, Australia, New Zealand, Japan, Iceland, Norway or Switzerland. It is however possible to submit for registration products whose registration process is still ongoing provided that a regulatory authority in at least one of these jurisdictions issued a positive opinion or a letter of approval. This is a major departure from the previous guidelines which permitted filing on the basis of a letter of approval or positive opinion only from the FDA or EMA.

The Guidelines further provide that the switching from the reference to the biosimilar product will be evaluated as part of the review of the biosimilar dossier and, if approved, will be indicated in the certificate of registration. The biosimilar applicant is therefore also required to file information on whether switching is permitted in other jurisdictions. The Guidelines additionally provide that initiating treatment with a biosimilar product or “one-time switching” of a patient to a biosimilar product are subject to the clinician’s discretion following consultation with the medical institution. Compared to the previous procedures, the revised Guidelines accelerate and facilitate biosimilar substitution.

This update article is provided for general information only and is not in lieu of legal advice. Please contact us directly for any required advice on specific matters.