Act4Biosimilars, a global initiative founded and sponsored by Sandoz, announced the launch of the Deep Dive Report for the 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 flexible guidance that 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
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.
