menu

The main health challenges within the Middle East and North African (MENA) region are beginning to mirror those in Western countries,1 with diabetes affecting more than 1 in 10 adults,2 and cancer-related mortality rising.3 The countries of the MENA region are economically diverse. While some countries in the region have been able to adjust their healthcare expenditure to provide biologic therapies, others – such as Egypt and Algeria – are finding it more difficult. Several countries have already established their own regulatory frameworks for biosimilar approval, with Jordan leading the way with approval of the first biosimilar within the region. Interest in biosimilar research in the MENA region is growing and clinical trials are already underway in a number of countries. 

Current access to originator biologics in the Middle East and North Africa   +

Many countries within the MENA region are facing a transition in terms of healthcare, towards the need for management of chronic diseases and the added pressures that this brings.1 While some countries in the region have been able to adjust their healthcare expenditure to accommodate the introduction of costly new treatments, for others – such as Egypt and Algeria – this is proving more difficult. The MENA region has the highest prevalence of diabetes in the world, with more than 1 in 10 adults now living with the condition.2 In Jordan, insulin is the most important biotherapeutic product in clinical use. Anti-cancer biologics are also widely used, because cancer is now the second most frequent cause of death after heart disease in Jordan, and is continuing to rise.3

The requirement for biologics is placing a growing burden on healthcare systems and patients alike.3 A recent survey of access to innovative cancer drugs in nine Middle Eastern countries (Bahrain, Egypt, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, and United Arab Emirates) has shown that, while healthcare expenditure per cancer case in the Middle East is widely comparable to the expenditure in France and the UK, the cost of cancer drugs in relation to the total cost of cancer care in these selected Middle Eastern countries is far higher – approximately 30%, compared with 12% in the UK, and 25–27% in France and the USA.4

Cost is also seen as a driver of suboptimal use of biologic therapies across the region in relation to accepted international standards for rheumatoid arthritis (RA). At a meeting of 28 rheumatologists from MENA countries (Algeria, Egypt, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, Syria, Tunisia, and United Arab Emirates), 71% agreed with European League Against Rheumatism (EULAR) recommendations for introduction of biologic therapy for disease-modifying anti-rheumatic drug (DMARD)-naïve patients with poor prognostic markers, but only about half of those asked said they were able to comply. The main obstacle to implementation was confirmed to be cost and access to biologic drugs.5

Research has shown that the proportion of patients with RA who are treated with anti-tumor necrosis factor (TNF) drugs varies according to economic status of the country; in many countries in the MENA region, this amounts to 2% or less.6 In the USA, for example, 40% of patients with RA are on biologics, compared with only 5% in the United Arab Emirates.7 The introduction of biosimilars should not only facilitate access to effective biologics, but may also have the potential to create substantial savings for national health sectors within the MENA region.8

Learn more about Biosimilars by Disease >> 

Regulatory guidelines in the Middle East and North Africa   +

The biotechnology industry in the MENA region is relatively advanced, and several countries have already established their own regulatory frameworks for biosimilar approval. Examples of these are shown in the table below. Jordan is leading the way in the region, having adopted the European Medicines Agency (EMA) guidance for biosimilars in 2008. Jordan’s own national guidance for the regulation of biosimilars is now in development.9

It is important to note that some earlier versions of non-originator biologics – known as ‘copy biologics’ (or ‘biogenerics’ in Iran) – were licensed in MENA countries before the introduction of formal regulatory guidance requiring rigorous comparability testing (equivalent or close to the international standards). Copy biologics and biosimilars should be differentiated from a regulatory perspective, however, unfortunately local reports and statistics do not always reflect this differentiation.

Biosimilars legislation in some countries within the MENA region

Country

Regulatory agency

Biosimilar regulation

Approved biosimilars*
(February 2015)

Egypt

EDA
Egyptian Drug Authority

No. Draft guidance issued December 2012.10 Go now!

None

Iran

NRA
Iranian National Regulatory Authority

No.11,12 Go now!

None – copy biologics only (known locally as ‘biogenerics’)

Jordan

JFDA
Jordan Food and Drug Administration 

Yes, issued in 2015. Based on EMA guidance.9 Go now!

Yes

Saudi Arabia

FDA
Saudi Food and Drug Authority

Final guidance issued December 2010.13 Go now!

Information pending

*Products approved before the date of the national regulatory guidance may not have undergone full comparability/biosimilarity testing and are considered ‘copy biologics’ rather than biosimilars

Learn more about Regulatory Requirements >>

Approved biosimilars in the Middle East and North Africa   +

Jordan approved its first biosimilar product in 2009 and is reviewing several others. Information on approved biosimilars within other MENA countries and their potential financial impact is awaited.

Future of biosimilars in the Middle East and North Africa   +

Interest in biosimilar research in the MENA region continues to grow, with the clinical trials of biosimilar products underway in some countries, most notably Jordan. Analysts predict a future upsurge in interest in biosimilars across the MENA nations.14

References   +

1. The World Bank, 4 September 2013. In the Middle East and North Africa, health challenges are becoming similar to those in Western countries.
http://www.worldbank.org/en/news/press-release/2013/09/04/middle-east-north-Africa-health-challenges-similar-western-countries. Accessed 26 March 2015.
2. International Diabetes Federation. IDF Diabetes Atlas 6th edition. 2013. http://www.idf.org/sites/default/files/EN_6E_Atlas_Full_0.pdf. Accessed 16 March 2015.
3. Haddadin RD. Concept of biosimilar products in Jordan. Biologicals (2011) 39:333–335.
4. Kasteng F, Wilking N & Jönsson B. Patient access to cancer drugs in nine countries in the Middle East. http://www.comparatorreports.se/Middle%20East%20oncology%20drug%20uptake%20Final%20report%20Sept%2015%202008.pdf. Accessed 16 March 2015.
5. Zorkany BE, Alwahshi HA, Hammoudeh M et al. Suboptimal management of rheumatoid arthritis in the Middle East and Africa: could the EULAR recommendations be the start of a solution? Clin Rheumatol (2013) 32:151–159.
6. Hammoudeh M. Rheumatoid arthritis management: Views from around the world. Establishment of registries and guidelines in the Africa Middle East region. Presentation at American College of Rheumatology 2013. https://acr.confex.com/acr/2013/recordingredirect.cgi/id/2430. Accessed 21 April 2015.
7. Lutf A, Poil AR & Hammoudeh M. Characteristics of patients with rheumatoid arthritis in Qatar: a cross-sectional study. Int J Rheum Dis (2014) 17:63–65.
8. Cheraghali AM. Biosimilars; a unique opportunity for Iran national health sector and national pharmaceutical industry. Daru (2012) 20:35.
9. BRIC Wall, 5 October 2015. Jordan FDA issues a guideline for the registration of biosimilars. https://bricwallblog.wordpress.com/2015/10/05/jordan-fda-issues-a-guideline-for-the-registration-of-biosimilars/. Accessed 2 November 2015.
10. Generics and Biosimilars Initiative Online, 1 March 2013. Egypt issues draft guidelines for biosimilars. http://www.gabionline.net/Guidelines/Egypt-issues-draft-guidelines-for-biosimilars. Accessed 1 April 2015.
11. Generics and Biosimilars Initiative Online, 11 January 2013. Significance of locally produced biosimilars in Iran. http://www.gabionline.net/Biosimilars/Research/Significance-of-locally-produced-biosimilars-in-Iran. Accessed 12 February 2015.
12. Generics and Biosimilars Initiative Online, 3 February 2012. Production of 24 biogeneric products in Iran by 2012. http://gabionline.net/Biosimilars/News/Production-of-24-biogeneric-products-in-Iran-by-2012. Accessed 12 February 2015.
13. Saudi Food and Drug Authority. Guidelines on biosimilars. Version 1.1, 12 December 2010. http://www.sfda.gov.sa/en/drug/drug_reg/Regulations/DrugMasterFileRequirementsfortheRegistrationofBiosimilars_v11.pdf. Accessed 16 March 2015.
14. Informa Life Sciences’ 3rd Annual. Biosimilars and biotech in Turkey and MENA. http://www.ieis.org.tr/ieis/assets/media/files/Program.pdf. Accessed 16 March 2015.

Video Spotlights
Industry perspective: How can biosimilars influence access to care?
Industry perspective: How can biosimilars influence access to care?
Quintiles perspective: How does the regulation of biosimilars differ from that of small-molecule generics?
Quintiles perspective: How does the regulation of biosimilars differ from that of small-molecule generics?
Investigator perspective: Extrapolation: Gaining approval for additional indications
Investigator perspective: Extrapolation: Gaining approval for additional indications