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Authors Review Global Biosimilars Regulatory Landscape, Market Growth Projections


Many governments have aligned their guidelines with those published by the World Health Organization (WHO) and the European Medicines Agency (EMA).

Biosimilars markets are expanding rapidly around the globe due to growing demand and increasing production capacity, but governments across the Asia Pacific region, Latin America, and the Middle East and Africa must encourage more local manufacturing to increase access to treatment and lower costs, according to a set of papers by researchers in India.

Three studies published in Preparative Biochemistry & Biotechnology by Anurag S. Rathore and Ankita Bhargava of the Indian Institute of Technology in Delhi lay out the biosimilar approval guidelines and market growth projections for several countries in each region. Many governments have aligned their guidelines with those published by the World Health Organization (WHO) and the European Medicines Agency (EMA).1-3

Asia represents 32.8% of the global market, with India, China, Malaysia, and Thailand offering well-developed regulatory pathways and showing strong demand. The Indian market is expected to climb from $2.2 billion in 2017 to $40 billion by 2030, thanks in part to considerable government subsidies. The Chinese biosimilars market is considered less mature, and it is projected to quadruple in value from $2 billion in 2018 to $8.1 billion in 2025.

Growth in Asia will be driven by factors including enormous unmet need in China, expansion of universal health care in Thailand, Indonesia, and other countries, and proliferating partnerships between global pharmaceutical companies and domestic manufacturers, the authors say.

“Most of the emerging economies are dependent upon major biologics manufacturers based in developed economies, something that has resulted in poor affordability and accessibility to this class of treatments. Most Asian countries…have established biosimilar regulatory pathways and are encouraging establishment of domestic development and manufacturing capabilities,” they write.

In Latin America, the market was valued at $517 million in 2018 and will exceed $3.9 billion by 2025, according to a recent market analysis. The top producer is Brazil followed by Argentina and Mexico, with a combined 44 similar biotherapeutic products (SBPs) in the 3 countries. In the trade bloc that includes Chile, Paraguay, Uruguay, and Venezuela another 18 products have been approved.

Latin American governments are promoting biosimilars to control spending as cancer, diabetes, and other chronic conditions become more prevalent, Rathore and Bhargava write. But the countries must strengthen their regulatory systems in the areas of pharmacovigilance, personnel training, data analysis, and guideline design, and support the establishment of more domestic producers, they say.

In the Middle East and Africa, the market was valued at $344.8 million in 2018 and was expected to grow to about $2.1 billion by 2025. Granulocyte colony-stimulating factor biosimilars are the most-used products, followed by insulin, interferon, and human growth hormone.

Nations with active biosimilar programs include Turkey, where 38 products are available, 13 of them produced in the country, and Egypt, where there are more than 55 products. Approved biosimilars in Saudi Arabia include Remsima, filgrastim, somatotropin, insulin glargine, and 4 oncology products. Nigeria has a local biosimilar production facility owned by a French pharmaceutical company.

Aging populations and increasing rates of diabetes and other high-cost diseases are driving the growth of Middle Eastern and African biopharma markets, but use of biosimilars is increasing slowly because few physicians are aware of them, the study says. The authors also note a burgeoning counterfeit drug market in Africa due to the high cost of biologics.

They call for government action to improve public trust in the drugs’ safety and efficacy; creation of clear legislation and pharmacovigilance systems; and assistance from WHO in the establishment of regulatory and risk management infrastructures.


  1. Rathore AS, Bhargava A. Regulatory considerations in biosimilars: Asia Pacific regions. Prep Biochem Biotechnol 2021;51(1):1-8, DOI: 10.1080/10826068.2020.1815061
  2. Rathore AK, Bhargava A. Regulatory considerations in biosimilars: Latin American region. Prep Biochem Biotechnol 2021;51(2):201-206. DOI: 10.1080/10826068.2021.1876729
  3. Rathore AS, Bhargava A. Regulatory considerations in biosimilars: Middle East and Africa regions. Prep Biochem Biotechnol 2021;51:8, 731-737, DOI: 10.1080/10826068.2021.1959346

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