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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
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Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
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Expert Consensus Recommendations on a Biosimilars Value Framework for the Gulf Cooperation Council Countries.

Khalid A Alnaqbi1,2,3, Ahmed Al-Jedai4,5, Mohamed Farghaly6

  • 1Rheumatology Division, Sheikh Tahnoon Medical City and Tawam Hospital, Al Ain, UAE. kalnaqbi@gmail.com.

Therapeutic Innovation & Regulatory Science
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Summary

A new biosimilar value framework was developed for Gulf Cooperation Council (GCC) countries, emphasizing trust, cost savings, and local context. Educational initiatives and incentives are key to promoting biosimilar adoption among all stakeholders.

Keywords:
AdoptionBiosimilarsGulf cooperation councilPolicyValue

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Area of Science:

  • Pharmaceutical policy
  • Health economics
  • Drug development

Background:

  • Biosimilar adoption varies globally, influenced by policy and stakeholder engagement.
  • Developing tailored frameworks is crucial for optimizing biosimilar uptake in diverse healthcare markets.
  • The Gulf Cooperation Council (GCC) region presents unique opportunities and challenges for biosimilar integration.

Purpose of the Study:

  • To develop a biosimilar value framework specific to the needs of Gulf Cooperation Council (GCC) countries.
  • To identify key factors influencing biosimilar adoption through expert consensus.
  • To provide actionable recommendations for policymakers and stakeholders in the region.

Main Methods:

  • Expert panel meeting with ten key opinion leaders from five GCC countries (UAE, KSA, Kuwait, Oman, Qatar) in November 2022.
  • Discussion structured around a conceptual biosimilar value framework and a review of existing biosimilar policies.
  • Analysis of factors positively influencing biosimilar adoption in the GCC region.

Main Results:

  • Agreement on a biosimilar value framework for GCC countries, centered on trust, cost savings, and contextual factors.
  • Emphasis on educational initiatives to build stakeholder trust and knowledge regarding biosimilars.
  • Recognition of incentives and implementation efforts as critical drivers for biosimilar adoption.

Conclusions:

  • The proposed biosimilar value framework is the first of its kind for Arab countries.
  • The framework aims to guide policymakers in promoting biosimilar adoption in both high-income and low- to middle-income GCC countries.
  • Successful implementation requires addressing trust, cost, and contextual considerations.