SAUDI ARABIA Law and Practice Contributed by: Saud Alromi, Mostafa Ihab, Mohamed Ramadan and Saleh Albadry, Mohammed AlDhabaan & Partners Eversheds Sutherland
3. Biosimilar Market Entry 3.1 Infringing Acts
Pricing Process The pricing process is handled by the Registration Committee for Pharmaceutical Companies, Manufac ‑ turers and their Products. Pricing decisions are based on multiple factors outlined in Article 2 of the Pricing Rules, including therapeutic value, prices of alterna ‑ tives, and economic studies. There is insufficient data on the existence of an auto ‑ matic notification system to inform originators about The Pricing Rules do not contain specific provisions on indication-specific pricing. All concentrations and pack sizes of the same product are subject to unified pricing rules. Administrative Appeals According to the Policy of Appeal to Drug Sector Deci ‑ sions, a first appeal to pricing decisions can be sub ‑ mitted 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 insuffi ‑ cient data as to the existence of a notification sys ‑ tem. Recent regulatory enforcement trends indicate increased SFDA oversight. According to the SFDA Pharmacovigilance Inspection Section – Annual Report 2024 (National Pharmacovigilance Center), the SFDA conducted 18 full pharmacovigilance inspec ‑ tions, carried out 25 re-inspections and escalated four MA holders to the legal track for persistent non- compliance. This reflects a tightening of post-market regulatory control affecting pharmaceutical market participants. Pricing information for registered drugs is publicly available through the SFDA’s website. generic pricing applications. Second Medical Use Patents
There are no differences in how infringing acts are treated between biologics or biosimilars and small molecule pharmaceuticals in Saudi Arabia. The Patent Law does not make any specific distinctions regard ‑ ing infringement rights between biologics and small molecules. 3.2 Data and Regulatory Exclusivity The key differences for biologics and biosimilars com ‑ pared to small molecules are as follows. Price Impact According to Article 6 of the Pricing Rules, when the first biosimilar enters the market, the price of the refer ‑ ence biological product is reduced by 20% (compared to a 25% reduction for small molecule generics under Article 4). Pricing Structure According to Article 7 of the Pricing Rules, the pricing structure is as follows: • first biosimilar – maximum 75% of the reference biological product’s pre-reduction price; • second biosimilar – maximum 65% of the reference biological product’s pre-reduction price; and • third and subsequent biosimilars – maximum 55% of the reference biological product’s pre-reduction price. 3.3 Acceptable Pre-Launch Preparations There are no specific differences in pre-launch prep ‑ aration exemptions between biologics or biosimilars and generics. Article 47 of the Patent Law provides the same limited “non-commercial activities relating to scientific research” exemption without distinguishing between product types. 3.4 Publicly Available Drug and Patent Information There are no differences. Saudi Arabia does not have an Orange Book equivalent system. The SFDA main ‑ tains public lists of approved drugs and products pending approval.
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