Shaping the Future of Medicine in MENA with Generics and Biologics

The Middle East and North Africa’s pharmaceutical sector is advancing through increased focus on generics and biologics. Generics are lower-cost versions of branded drugs with identical dosage and effects, available after patents expire. This affordability expands access across all communities. Biologics are complex medicines derived from living cells, designed to treat difficult diseases like cancer and autoimmune disorders. Biosimilars mimic biologics closely but are more affordable, playing an important role in MENA’s healthcare evolution. This dual strategy ensures wide access with generics and advanced care with biologics, subjects covered in depth at the Pharma Conference Dubai.

MENA’s pharmaceutical market growth is driven by changing demographics, policy reforms, and manufacturing progress. Saudi Arabia and the UAE promote local generics production to cut import reliance and widen medicine supply. Vision 2030 in Saudi Arabia encourages procurement and clinical testing of generics. Iran excels in generics manufacturing for local markets, while Jordan and Algeria address surging healthcare demands with affordable generic drugs.

Biologics and biosimilars represent MENA’s fastest-growing pharmaceutical categories, with the biologics market valued at $4.1 billion from 2015-2019. Saudi Arabia leads biologics sales with $1.8 billion, followed by Egypt and UAE. Biosimilars are projected to grow nearly 25% annually until 2026, driven by rising healthcare investments and treatment innovation demands. Their combined growth signals MENA’s commitment to making healthcare both affordable and advanced.

Regulatory frameworks, influenced by international guidelines but tailored regionally, govern biologics and biosimilars rigorously. SFDA and similar bodies oversee safety and efficacy but face challenges from varying country-specific regulations that slow biosimilar uptake. Generics receive increasing support through local manufacturing initiatives, although approval consistency varies. These regulatory topics are explored at the Pharma Exhibition in Dubai.

Pharmaceutical manufacturing capacity has expanded dramatically; UAE’s manufacturing sites rose from four in 2010 to 23 in 2022, driven by cancer drug demand, biosimilar approvals, specialty generics, and government initiatives. Mubadala and G42 partnerships seek to establish biopharma hubs in Abu Dhabi. Mubadala’s 2024 acquisition of KELIX Bio strengthens generics production, complementing economic diversification. Patent expiration strategies bolster global competitiveness, with GCC states focusing on branded/generics and African regions on generics scale. For details, see Dubai Pharma Expo 2026.

National programs support biologics and biosimilars advances. Saudi Arabia emphasizes biotech growth under Vision 2030; UAE invests in biosimilars via Mubadala; Egypt tightens biosimilar regulations. Despite obstacles like regulatory fragmentation and import reliance, collaborations adhering to EMA/FDA standards reinforce sector robustness, a focus at Pharmaceutical Events in Dubai.

Generics reduce medicine costs and extend access, exemplified by Egypt’s successful market policies. Biosimilars add economic benefits, regulated by SFDA to ensure safety and encourage competition. GCC Pharmacy and Therapeutics Committees manage formulary decisions and biosimilar integration including substitution policies. The UAE targets 50% local drug production by 2030, covering both generics and biosimilars, frequently discussed at Upcoming Events in UAE.

Collaborative ventures such as Oman’s public-private partnerships, Hikma-Celltrion’s biosimilar initiative, Biocon-Tabuk licensing, and Egypt’s leading adoption of WHO biosimilar guidelines propel MENA’s pharmaceutical growth. India remains a major generics and biosimilar supplier, supported by Make in India. Cooperation importance was emphasized at the 2nd MENA Stakeholder Meeting on Biosimilars and Upcoming Pharmacy Conferences in Dubai.

Country highlights include Saudi Arabia’s advanced biotech leadership with regulatory alignment, UAE’s personalized medicine emphasis and streamlined biosimilar pathways, Egypt’s biosimilar regulatory system, and Jordan and Tunisia’s EMA compliant frameworks promoting sector growth. These advances are showcased at Upcoming Pharmacy Conferences in Dubai.

Looking ahead, MENA pharma’s future relies on innovation, regulatory coherence, and infrastructure investments. Key players SFDA, MOHAP, and EDA, supported by GCC Health Council, drive harmonization. The region strives to be a global leader in affordable, innovative medicine, discussed extensively at Pharma Trade Shows in Dubai.