The landscape of biosimilars in Saudi Arabia: preparing for the next decade

ABSTRACT

Introduction

The government of the Kingdom of Saudi Arabia (KSA) has developed a well-defined strategy to restructure the health sector and operate on value-based principles. Biosimilars are a viable option for increasing accessibility while lowering health-care costs.

Areas covered

We describe the current and future biosimilar landscape in KSA. We discuss the growth of the biosimilar market, the regulatory approval process, biosimilar adoption, and the potential impact on health-care systems and patient outcomes.

Expert opinion

The biosimilar market in KSA is expanding and expected to continue this trajectory in the coming decade. The growth of the market is influenced by the KSA health transformation initiative, the well-defined regulatory framework for biosimilars set by the Saudi Food and Drug Authority (SFDA), and the adoption of biosimilars by health-care providers. Overall, the biosimilar regulation is evolving and the future of biosimilars looks promising in KSA. Biosimilars offer a more cost-effective alternative, which can help to expand access to more treatment options for patients and contribute to cost saving for the health-care system.

KEYWORDS:

• Biosimilars
• Saudi Arabia
• market
• regulation
• healthcare

Article highlights

• The health-care transformation in KSA is a key driver to promote acceptability and adaptability to use biosimilars in clinical practice.

• Biosimilars are a promising strategy to reduce the increasing trend in the pharmaceutical expenditure in KSA.

• The SFDA biosimilar regulations are aligned with those in highly regulated regions with approvals based on regulatory reliance and independent scientific assessment.

• There are 38 SFDA-approved biosimilars with the number expected to rise in the near future to satisfy the high demand of cost-efficient therapies.

• Biosimilar regulation in KSA is evolving and maturing in the evaluation and monitoring of safety, efficacy, and quality of products entering the market.

• The SFDA has created regulatory incentives to improve accessibility and availability of affordable alternatives for cost-efficient therapies.

Declaration of Interest

AR Almutairi, AM Al-Sami, and A Alsayyari are employees of the Saudi Food and Drug Authority. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Disclaimer

The contents of this manuscript are solely the authors’ views and may not be understood or quoted as being made on behalf of or reflecting the position of the Saudi Food and Drug Authority.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.