SAUDI ARABIA Law and Practice Contributed by: Dr Saud Alromi, Mostafa Ihab, Mohamed Ramadan and Saleh Albadry, Mohammed Al Dhabaan & Partners Eversheds Sutherland
2.4 Publicly Available Drug and Patent Information Saudi Arabia does not have an Orange Book equivalent system. The SFDA maintains a pub - lic list of the approved drugs and those awaiting approval. While the SFDA issued a Regulatory Framework for Drugs Approval (the “Regulatory Frame - work”), it does not include a system for notifying marketing authorisation (MA) reference product holders about generic/biosimilar applications. Monitoring is probably needed as there is no sufficient data on the existence of an automatic notification system. 2.5 Reimbursement and Pricing/Linkage Markets There is no formal patent linkage system in Sau - di Arabia that connects MA or pricing/reimburse - ment decisions to patent status. However, the SFDA’s Pricing Rules for Pharmaceutical Prod - ucts (the “Pricing Rules”) provide some relevant guidelines. Patent Status Considerations For innovative and biological products manu - factured locally under licence from international companies during the patent term, they must be priced at the same price as the innovative prod - uct (Article 3(D) and 3(E) of the Pricing Rules). Once patents expire, products are treated as generics for pricing purposes. Pricing Process The pricing process is handled by the Registra - tion Committee for Pharmaceutical Companies, Manufacturers and their Products. Pricing decisions are based on multiple factors outlined in Article 2 of the Pricing Rules, includ -
ing therapeutic value, prices of alternatives, and economic studies. There is insufficient data on the existence of an automatic notification system to originators about generic pricing applications. Second Medical Use Patents The Pricing Rules do not contain specific provi - sions on indication-specific pricing. All concen - trations and pack sizes of the same product are subject to unified pricing rules. Administrative Appeals According to the Policy of Appeal to Drug Sector Decisions, a first appeal to pricing decisions can be submitted within 60 days from notification, with a 60-day review period. A second appeal to pricing decisions can be filed within 30 days of the first appeal decision, with a 30-day review period. Appeals must follow the procedures outlined in the Policy of Appeal to Drug Sector Decisions. There is insufficient data as to how common appeals are. Monitoring Requirements Monitoring is probably needed as there is no suf - ficient data as to the existence of a notification system. Pricing information for registered drugs is publicly available through the SFDA’s website.
3. Biosimilar Market Entry 3.1 Infringing Acts
There are no differences in how infringing acts are treated between biologics or biosimilars and small molecule pharmaceuticals in Saudi Arabia.
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