Advancing Care: The Role of Generics and Biologics in MENA

The transformation of healthcare in the MENA region is strongly influenced by the growing adoption of generic medicines and biologics. Generics provide cost-wise alternatives to branded drugs, having the same dosage, strength, and therapeutic effect, but at lower prices post-patent expiry. These drugs play a critical role in reducing healthcare costs and expanding access across all socioeconomic levels. Meanwhile, biologics—complex drugs derived from living cells—are used for treating challenging diseases like cancer and autoimmune disorders. Biosimilars, which approximate the original biologics but are more affordable, are gaining increasing importance in MENA’s health frameworks. The synergy between generics and biologics highlights a balanced healthcare strategy promoting both affordability and cutting-edge treatment, topics frequently explored at events like the Pharma Conference Dubai.

The pharmaceutical market in MENA is expanding swiftly due to healthcare reforms, rising patient populations, and pharmaceutical manufacturing advances. Countries such as Saudi Arabia and UAE prioritize local generic production to minimize imports and improve medicine access. Saudi Arabia’s Vision 2030 supports this through enhanced procurement and clinical trials, while Iran excels in producing cost-effective generics for domestic supply. In addition, Jordan and Algeria focus on producing affordable, well-quality generics to meet surging healthcare demands.

Biologics and biosimilars make up a rapidly growing segment, with MENA’s biologics market reaching $4.1 billion between 2015 and 2019 and growing annually at 14.5%. Saudi Arabia is the leader in biologics sales, generating $1.8 billion, with UAE, Egypt, and Algeria also significant contributors. Biosimilars are expected to reach a CAGR near 25% between 2021 and 2026 due to higher healthcare funding and demand for innovative therapies. Together, these sectors illustrate the region’s commitment to expanding accessible healthcare and becoming a pharmaceutical innovation center.

The regulatory environment in the region aligns with international norms like FDA and EMA but adapts to local priorities. Agencies such as the SFDA enforce rigorous testing and clinical evaluations for biologics and biosimilars, while also integrating GCC-wide regulations. However, regulatory inconsistencies between countries often slow biosimilar adoption. Generic drug approvals are generally supported by governmental localization policies, though certain countries face approval delays. Harmonizing regulations and involving stakeholders are critical for enhancing uptake, a frequent theme at the Pharma Exhibition in Dubai.

Manufacturing infrastructure in MENA is growing robustly. UAE’s pharmaceutical facilities expanded from 4 in 2010 to 23 by 2022, driven by demand for affordable oncology drugs, biosimilars, and specialty generics, supported by government investments. Initiatives like the Mubadala-G42 partnership in Abu Dhabi focus on developing biopharmaceutical hubs producing vaccines and therapeutics. Mubadala’s acquisition of KELIX Bio further accelerates its generics capacity, contributing to economic diversification and competitive global positioning. The strategy involves leveraging expired patents to grow regional pharmaceutical markets, a topic detailed at the Dubai Pharma Expo 2026.

Biologics and biosimilars benefit from governmental push toward innovation. Saudi Arabia’s Vision 2030 directs resources to biopharma research and local production, while the UAE’s Mubadala company invests heavily in biosimilars and complex generics. Egypt enhances regulatory measures and safety monitoring of biosimilars. Despite progress, challenges such as regulation differences and import reliance remain but are addressed through public-private cooperation aligned with international standards, issues discussed extensively at Pharmaceutical Events in Dubai.

Generics improve drug affordability and patient access, with Egypt’s government policies as a significant example. Biosimilars complement this by reducing biologics costs under SFDA’s regulatory framework ensuring safety and competitiveness. Pharmacy and Therapeutics Committees in GCC nations manage formularies considering clinical and economic factors, prescribing, and monitoring biosimilars—including substitution policies. The UAE aims to locally produce 50% of its medicines by 2030, covering generics and biosimilars in its pharmaceutical strategy. These initiatives are part of broader talks at Upcoming Events in UAE.

Collaborative efforts drive regional progress. Oman fosters sustainable biopharma through partnerships with international firms to boost biosimilar supplies. Hikma and Celltrion’s partnership increases essential biosimilar access and healthcare education. Biocon’s deal with Tabuk Pharmaceuticals facilitates regional diabetes treatment access. WHO biosimilar guidelines are adopted gradually, led by Egypt, while India remains the largest generic and biosimilar supplier to MENA, aided by its Make in India program. The importance of regional cooperation was stressed at the 2nd MENA Stakeholder Meeting on Biosimilars and highlighted at Upcoming Pharmacy Conferences in Dubai.

Key national insights: Saudi Arabia builds biotech leadership with SFDA’s stringent alignment to EMA and FDA; the UAE leverages personalized medicine and fast-track biosimilar regulation attracting global firms; Egypt’s biosimilar regulatory maturation and incentivization strengthens its market presence; Jordan and Tunisia maintain EMA-aligned standards encouraging generics and biologics investment. These advances are featured at key events like Upcoming Pharmacy Conferences in Dubai.

The future of MENA pharmaceuticals is bright but complex. Progress depends on addressing regulatory gaps and infrastructure shortfalls through regional coordination, ongoing reforms, and investment. Leading regulatory bodies—SFDA, MOHAP, EDA—play essential roles, supported by the GCC Health Council’s push for unified policies. This evolving ecosystem positions MENA to lead in affordable, innovative healthcare delivery, with ongoing discussions at Pharma Trade Shows in Dubai.