Regulatory Framework for Supporting the Integration and Use of Biosimilars in the Private Healthcare System of the United Arab Emirates (UAE).

Introduction Biologics are substantial in the treatment of different diseases; however, they can burden the healthcare systems due to their high cost. Biosimilars can help healthcare systems keep their financial sustainability and patients access to biological therapies. The research objective is to formulate a framework for integrating biosimilars in the private healthcare sector of the United Arab Emirates (UAE). This framework was based on local stakeholders' recommendations to ensure alignment with the UAE's healthcare market dynamics and needs. Methods Stakeholders from the private sector and regulators from the public sector completed a questionnaire tailored to the UAE healthcare system, based on recommendations from local stakeholders. The questionnaire encompassed five key domains: overall perceptions of biosimilars, pricing and reimbursement strategies, financing protocols, information sharing, and monitoring practices. They filled out the questionnaire during a workshop held during the 2 Conference of the Emirates Health Economics Society (EHES), conducted from 18 to 20 October 2022, in Jumeirah Emirates Towers, Dubai. Results Stakeholders showed a positive perception of biosimilars. They believed switching to biosimilars is safe, especially when it is medically supervised. Also, they advocated initiating treatment-naïve patients on the less expensive option. They also recommended that the first biosimilar should be priced at a minimum of 30% below the original product, with a preference for a discount of 50%. They also proposed that the price of the subsequent biosimilars is 80%-90% of the previous biosimilars. Health technology assessment (HTA) of biosimilars was deemed necessary by seven (58%) of the stakeholders only if the manufacturers submitted for expanding the reimbursed indication beyond the originator's licensed indications. They recommended introducing clinical guidelines for biosimilar switching and clinical communications to show biosimilars' effect on access to biological therapies. They advocated introducing strict financing protocols against which the prescribing patterns of the clinicians are monitored. Conclusion The policies proposed by the stakeholders are designed to enhance financial sustainability while optimizing spending efficiency within the Emirati healthcare system. In addition, it may enable budget reallocation to support reimbursement of high-value health technologies.