New MOH guidelines to expedite approval of biosimilars and generics

Two recent MOH Guidelines which just entered into force provide for an expedited approval process of biosimilars and generic products and are intended to prioritize and significantly accelerate launch of biosimilars and generic products.

The ‘Prioritized Approval Process’ Guidelines provide that if the marketing of a biosimilar/generic product is expected to generate significant cost savings, the two first petitions for the approval of a ‘prioritized product’ shall be evaluated within 150 business days.

An additional prioritized route, irrespective of showing of cost savings, is provided for biosimilars in accordance with their registration status in foreign regulatory authorities. Biosimilars which were registered in the last three years in at least two of the listed regulatory authorities (FDA, EMA (centralized procedure), TGA (AU), MHRA (UK), SMC (Scotland), HC (Canada) wherein at least one registration must be in the FDA or EMA) will be evaluated within 70 business days. Biosimilars which were registered in the last five years in at least one of the listed regulatory authorities will be evaluated within 120 business days.

The new MOH Guidelines signal that the IL MOH is determined to facilitate and accelerate the launch of biosimilars by focusing on product approvals in foreign regulatory authorities and capping the allowed period of time for local regulatory review. As the IL MOH regulatory process does not account for patent protection and Israel does not have Data Exclusivity protection for biological products, the new regulatory framework may prompt launch-at-risk of biosimilars.

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.