This section provides an overview of biosimilar policies implemented in the GCC countries as published in the literature until 2022.

Neither research and development nor manufacturing policies specific to biosimilars have been implemented in the selected GCC countries. However, some countries have in place general provisions (thus also applicable to biosimilars) that favor local production. KSA, for example, has set a domestic manufacturing target of at least 40% of medicines [26].

Regulatory approval policies for biosimilars vary across the selected GCC countries. For example, when this project began, Oman did not have a clear pathway for approving biosimilars. Similarly, Kuwait and Qatar had not yet introduced specific regulatory approval pathways for biosimilars [27,28,29]. In contrast, KSA and the UAE have adopted streamlined regulatory processes, offering accelerated assessment and approval for biosimilars [26]. In the UAE, regulatory approval for a biosimilar can be sought two years before the reference biologic’s loss of exclusivity, with final approval granted only after the patent of the reference biologic expires [26].

The Pharmacy and Therapeutics Committee (PTC), composed of multidisciplinary experts, plays an essential role in optimizing pharmacy inventory, thereby enhancing patient care and reducing costs. The inclusion of drugs in formularies is based on the PTC’s evaluation, which considers clinical, ethical, legal, social, logistical, quality-of-life, safety, and economic factors [30]. Each GCC country’s PTC committee follows these criteria in their assessments. A well-managed formulary system aligns the organization’s and the country’s medication-use policies, available therapies, and regularly stocked medications, ensuring cohesion and efficiency. The PTC committee should set policies for prescribing, dispensing, and monitoring biosimilars including interchangeability or switching of biosimilars. Interchangeability describes the ability to substitute one medication with another that is anticipated to produce the same therapeutic outcome [31]. In the GCC countries, unless mandated by the regulatory body or hospital, the decision to switch between the reference product and a biosimilar, or between biosimilars, is left to the prescriber in consultation with the patient. The Department of Health (the regulatory authority in Abu Dhabi, UAE) has recently published a guide to biosimilars for HCPs mandating the use of biosimilars for naïve patients [32]. Similarly, some GCC countries like the UAE, KSA and Qatar utilize formulary management and tendering processes to manage the procurement and reimbursement of biosimilars. It is worth noting that in the Gulf countries, international non-proprietary names (INN; active substances) are not used alone within the formularies of biosimilars. Instead, they are often paired with brand names with specific batch numbers.

Overall, the GCC countries have taken a proactive approach to formulary management of biosimilars, leveraging regulatory frameworks, payment schemes, and procurement processes to expand access to these cost-effective treatments.

Policies about the pricing of biosimilars are in place in two of the selected GCC countries: the UAE and KSA. Both countries set biosimilars prices lower compared to the reference biologic, but with different approaches. The UAE requires a percentage reduction of biosimilars based on the price of the reference biologic, while KSA applies a tiered model, mandatory discounts of at least 25%, 35% and 45% on first, second and third biosimilar, respectively [26, 33].

Procurement policies in the UAE and KSA take the form of direct contracting with providers and tendering [26]. For example, there is generally direct contracting and tendering in the outpatient and inpatient settings in the UAE. A single-winner, national tender is organized every three years in the KSA, but health institutions can also directly contract with manufacturers. Both countries have implemented requirements for sustainable procurement.

The aim of demand-side policies is to increase the uptake of biosimilars in the market, for example, by incentivizing physicians to prescribe biosimilars through prescription quotas; establishing a targeted level for the quantity of prescriptions. These quotas are often accompanied by financial incentives or penalties if not achieved [34]. It is worth noting that, in Abu Dhabi SEHA Company, biosimilars are mandated to be used in inpatient settings. An overview of biosimilar demand-side policies for physicians, pharmacists, and patients in the selected GCC countries is provided in Table 3 which highlights the absence of such policies in these countries, except for clinical guidelines supporting biosimilar prescriptions in the UAE and KSA, and education/information initiatives for HCPs in the UAE, KSA [26], and Qatar. It is noteworthy that neither dispensing policies supporting biosimilar adoption (such as pharmacist substitution or regressive pharmacist margins, where pharmacists’ profit margins are inversely proportional to the medication’s cost) nor policies targeting patients have been adopted in these GCC countries.

Following a roundtable discussion, the panelists developed recommendations for a biosimilars value framework using a prioritization toolkit and incorporating their perceptions and practices (Table 4). Additionally, the expert panel proposed an implementation algorithm for biosimilars adoption and monitoring in the GCC countries (Fig. 2).

Implementation Algorithm of Biosimilars Adoption and Monitoring in the GCC Countries

Experts emphasized that building trust is crucial to driving the adoption of biosimilars across GCC countries. Conversely, the lack of trust among authorities, payers, patients, and caregivers was identified as the primary barrier to biosimilar adoption in Kuwait. This trust can be established through several means, including the assurance that the safety and efficacy of biosimilars are supported by international entities such as the European Medicines Agency (EMA) and the US Food and Drug Administration. Furthermore, trust can be strengthened by drawing on the experience with biosimilars in Western countries, gathering real-world data on immunogenicity and switching practices, and implementing monitoring tools to address any remaining concerns among HCPs and patients. A robust pharmacovigilance strategy including safety specifications for the biologic originator or biosimilar, is an essential driver for uptake and for identifying safety variations. This requires well-defined activities and proposed actions, including an evaluation of potential medication errors. This strategy should also include a risk management plan, providing additional information like medication guide supplements and access restrictions.

Trust can be strengthened further by informing and educating HCPs and patients with a view to raising their understanding of biosimilar concepts and terminology, and dispelling misperceptions [35]. For instance, when biosimilars were introduced in Abu Dhabi SEHA Company, several actions were taken including the distribution of educational materials to patients in some languages such Arabic and English. Additionally, HCPs were invited to attend educational sessions about biosimilars presented by physicians using local cases. This reflected the important role of HCPs in communicating with and reassuring patients. During the expert panel meeting, it was also suggested that the place of biosimilars in clinical practice should be included in treatment guidelines to overcome physician distrust in these products.

When examining future prospects for biosimilars in GCC countries, experts agreed that it is important to set up an ecosystem in which all stakeholders benefit from the adoption of biosimilars. It was argued that such an ecosystem should be founded on a solid regulatory assessment of biosimilars by authorities and should foster competition between manufacturers in the form of lower prices for healthcare payers and the provision of patient support programs that enable HCPs to offer a wider range of medications to patients, with the increased adoption of biosimilars contributing to a viable business model for manufacturers.

Additionally, at the time of the experts meeting, the limited information and regulations in the GCC countries regarding interchangeability hinder switching, which is a significant driver for biosimilar uptake. This switching is often motivated by the need for more suitable patient therapies due to efficacy or tolerability issues with previous biologic products [36].

With respect to tendering, experts discussed the Saudi experience with setting up a single-winner, national tender every three years in the public healthcare system. The result, where one manufacturer supplies the entire market for a relatively long period, is believed in KSA to guarantee low prices, minimize the need to switch patients from one product to another, simplify formulary management in health institutions, and reduce prescribing and dispensing errors. Manufacturers have an incentive to stay on the market as they also have the opportunity to supply the private market (which represents around 25-30% of the total Saudi market). Moreover, the danger of shortages is mitigated by imposing multiple tender conditions, including the need for the manufacturer to keep a stock of at least 30% of the required quantity and to pay for an alternative therapy in case of delayed or cancelled delivery.

Experts agreed with contextual drivers (country-specific considerations), trust and cost savings, as having an impact on biosimilar adoption in the GCC countries. Regarding contextual drivers, it was argued that Oman and Qatar consider it important that policies can be implemented with minimal effort, while KSA prioritizes the introduction of appropriate incentives. All experts emphasized the cost saving potential of biosimilars and, hence, the role that biosimilars can play in providing affordable healthcare to continuously growing populations in GCC countries. Biosimilars were also seen as a key instrument to widen access to healthcare for the large number of patients in the Gulf region. Therefore, it is important to make all stakeholders aware of the specific potential value propositions of biosimilars (e.g. cost savings, increased healthcare access, better treatment adherence, expansion of reimbursed indications) in GCC countries. Given that the importance of biosimilar value propositions may vary between GCC countries and between stakeholders, it was proposed that policies should be tailored to the local setting.