• Act4Biosimilars Deep Dive Report for Middle East and Africa highlights opportunities to increase biosimilar access by streamlining processes and prioritizing clear implementation strategies. 
  • A significant and timely opportunity, with USD 1.6 billion worth of biologics set to lose exclusivity in MEA by 2027.
  • The mission of Act4Biosimilars is to increase global adoption of biosimilar medicines by at least 30 percentage points in 30+ countries by 2030.
  • Dr. Hamdy Abdel Azim - Professor of Oncology at the Kasr El-Aini School of Medicine: Biosimilars have safety and efficacy rates equivalent to reference biologics, I am very proud to support their use in the treatment of Egyptian patients to provide the best possible care.

Egypt – Act4Biosimilars, a global initiative founded and sponsored by Sandoz,  announced the launch of the Deep Dive Report for Middle East and Africa (MEA), revealing the challenges impacting biosimilar adoption in this region, including Egypt, and the sizeable opportunity they represent for patients.

The Deep Dive Report for MEA encourages local stakeholders to use the Act4Biosimilars Action Plan, which offers strategies, tools, and activities needed to accelerate biosimilar adoption across the 4As – Approvability, Acceptability, Accessibility, and Affordability. The Action Plan offers guidance that is flexible and can be tailored to each country and supports the mission of Act4Biosimilars to increase global adoption of biosimilar medicines by at least 30 percentage points in 30+ countries by 2030.

Biosimilars offer a significant and timely opportunity, with USD 1.6 billion worth of biologics set to lose exclusivity in MEA by 2027.1

Professor Hamdy Abdel Azim, MSc, MD, Professor of Clinical Oncology, School of Medicine, Cairo University, and President of the Cairo Oncology Center, Egypt, commented, “The tremendously rising cost of anti-cancer drugs during the last two decades is now a major obstacle in providing an adequate treatment for a large number of cancer patients worldwide. This has been referred to as the financial toxicity of cancer treatment which is far more impactful in developing countries. Importantly, a massive increase in drug expenditure has been strongly attributed to the rapidly growing integration of biological drugs into the treatment of practically all cancer types during the early as well as advanced stages of the disease. Therefore, the introduction of biosimilars has been considered as a real game-changer in the way we approach cancer treatment in many countries including Egypt. ‘Biosimilar’ is a regulatory term to refer to a product that has been approved via stringent FDA or EU regulatory pathways.

I have seen firsthand how these relatively affordable, high-quality biological therapies drive better access to important medicines which not only improve patient outcomes, but also expand the options available. Integrating biosimilars into standard of care not only supports the sustainability of healthcare systems, but also aligns with our goals as oncologists to make essential cancer treatments equitably available to all. To this end, it should be emphasized that a biosimilar drug is not approved by FDA or the EMA unless the supporting preclinical and clinical studies are able to confirm that it perfectly matches its reference biologic medicine in terms of structural and functional properties, pharmacokinetics, pharmacodynamics, as well as clinical efficacy, safety, and immunogenicity. Hence, the doctor and patient can expect the same safety and efficacy profile for the approved indications. I am proud to have sided with the use of biosimilars for Egyptian patients and I remain steadfast in my commitment to leveraging these medicines to deliver the best possible care and ensure that no one is left behind in accessing the life-saving therapies they need."

Some progress has been made towards biosimilar adoption in MEA, with the Kingdom of Saudi Arabia, the United Arab Emirates, and Egypt among the regional market leaders1. However, in many countries, regulatory, procurement, and pricing frameworks, as well as medical guidelines, still demonstrate some inefficiency or tendencies to favor reference biologics. The report shares the following insights for Egypt:

  • Tender procurement processes fall under the auspices of the centralized Unified Procurement Authority, which uses a scoring system to differentiate between biosimilars and bio copies. Differentiation is also needed at a regulatory level to ensure that biosimilars are not disadvantaged by regulatory review timelines, with the roll-out of a fast-track registration route for biosimilars in Egypt by the Egyptian Drug Authority - similar to pathways used by the EMA and FDA - set to help introduce and implement the use of biosimilars more efficiently.
  • Clear guidelines on transitioning or starting a patient on a biosimilar medicine are needed to increase the confidence of healthcare professionals and patients in biosimilars.
  • Patients should feel comfortable using biosimilars without confusion, and this can be more effectively achieved by encouraging HCPs to take the time and resources needed to provide biosimilar education to patients.

The report also reveals that resistance towards the adoption of biosimilars can be fueled by a lack of independent and authoritative educational content. To support biosimilar acceptance among all stakeholders, country-specific educational content that is tailored to the needs of different therapeutic specialties should be made available. This is particularly important for healthcare professionals, who play a critical role in supporting patients through informed transitions.

Laura Wingate, Executive Vice President, Education, Support & Advocacy, Crohn’s & Colitis Foundation, and Act4Biosimilars Steering Committee member, said, “Biosimilars are a beacon of hope for patients in countries where biologics are often out of reach. Yet until necessary support for healthcare professionals is made available, including clear biosimilar guidelines and resources, the promise of these potentially life-saving medicines will remain unfulfilled for many across the region. Action is needed now to ensure a future where these biosimilars become a reality for all patients in need.”

Following the publication of the report, Act4Biosimilars will be supporting greater awareness of these barriers to biosimilar adoption across MEA with healthcare stakeholders. This includes exploring opportunities that support better adoption of biosimilars through the implementation of the aforementioned Action Plan.

-Ends-

About Act4Biosimilars

Act4Biosimilars is a global initiative aimed at increasing patient access to biologic medicines by facilitating greater Approvability, Accessibility, Acceptability and Affordability of biosimilars. Act4Biosimilars is led by a multidisciplinary Steering Committee of patient advocacy leaders, healthcare professionals, biosimilar experts, and industry leaders from around the world, with a Mission to increase the global adoption of biosimilars by at least 30 percentage points in 30+ countries by 2030. Act4Biosimilars seeks to bolster the global biosimilar movement by clearly aligning and informing action on biosimilar challenges and opportunities for patient access and sustainable healthcare and is supported by founding sponsor, Sandoz.

The Deep Dive Report series analyses the key challenges facing biosimilar adoption across different regions and is designed to be used by stakeholders (e.g., policymakers, regulators, payers, healthcare professionals, and patient advocacy organizations) alongside the already published Act4Biosimilars global Action Plan to drive targeted change. The Middle East and Africa Report follows 2023’s releases focused on Europe and the Americas region.

About biosimilars

A biosimilar is a successor to a biological medicine (also known as “reference medicine”) for which the patent has expired, and exclusivity has been lost. Biosimilars match their respective reference medicine in terms of quality, safety, and efficacy. Biosimilars are used in the treatment and prevention of many disabling and life-threatening diseases in oncology, rheumatology, dermatology, and many other indications2.

References

  1. Hegde, M., Hiremath, S., 2023. Unlocking the Promising Opportunities of Biosimilars in the Middle East and Africa Market. IQVIA. Act4Biosimilars aims to increase biosimilar adoption by at least 30 percentage points in 30+ countries by 2030.
  2. IQVIA, 2020. Realizing Biosimilar Potential in the Middle East & Africa White Paper.
  3. European Medicines Agency and European Commission, 2019. Biosimilars in the EU: information guide for healthcare professionals. Available from: https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf

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Ereny.labib@sandoz.com

 

Ereny Labib

Corporate internal and External Communication Manager

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