High costs and limited access have prevented some governments from investing in biotechnology products. However, as more biosimilars are introduced to the market, a growing number of Latin American countries are approving these advanced medicinal products, providing their populations with access to drugs that have revolutionized the treatment of some chronic diseases.

The US Food and Drug Administration (FDA) defines a biosimilar medicine as a biological product highly similar and with no clinically significant differences from the reference product already approved by the FDA, while the definition from the European Medicine Agency (EMA) is a medicine highly similar to other biotechnological product already approved. In addition, the World Health Organization has developed a prequalification program to help countries that lack a rigorous regulatory framework.

Recognizing the advantages biosimilars present, a growing number of Latin American countries have started to invest in these medicines.

Accessing biosimilars in LATAM

The development of biosimilars in Latin America varies significantly due to country-specific economic, political, regulatory, and cultural factors. For example, while Argentina, Peru, Chile, Guatemala, Panama and Costa Rica follow WHO guidelines, other countries have combined local requirements with international standards in developing biosimilar guidelines.

The approach to biosimilars falls into three main country categories. The first group includes Argentina, Brazil, Chile, Costa Rica, Colombia, Mexico and Peru, where markets are continuously growing, giving more opportunities to companies to commercialize biosimilar medicines. Argentina, Brazil, and Mexico now all have manufacturing sites for biological products and are seeking approval for these with the national regulatory authorities to improve access to biosimilars in the region.

The second group includes smaller markets, such as Bolivia, Ecuador, Paraguay and Uruguay, which don’t have manufacturing facilities and where the number of biosimilar products available on the market, or likely to be available on the market, remains low.

The final group comprises Cuba and Venezuela, where internal political uncertainty has made it  difficult to import biosimilar medicines.

Regardless of the approach, it is highly recommended to have a pre-submission meeting with the national regulatory authorities to clarify concerns and uncertainties, especially in those countries without a specific regulation.

Building collaboration with the regulators

Due to the non-specific nature of biosimilar regulations in most Latin American countries, companies have to evaluate market trends and evolving guidelines with regards to how they affect the submission strategy and registration timelines. Having defined regulations would enable companies to better plan their strategies, so it’s likely countries with the most progressive approach to biosimilar regulation will be the first to attract product developers. What is promising, however, is that most LATAM countries have chosen to follow the regulations and guidelines set out by the FDA, EMA, or WHO, so any company seeking to develop biosimilars for these countries should begin by ensuring they understand these regulations in order to prepare a good quality dossier.

It is also important to note that companies will be most eager to work with those countries with a collaborative regulatory authority when registering their biosimilar medicines. For their part, companies should be willing to participate in the consulting process with regulatory authorities to help them develop their guidelines, sharing knowledge from submitting in other markets, such as Europe and the U.S.

Building collaborative relationships with the regulatory authorities in LATAM countries can help companies to develop their strategies and gain access to valuable new markets.


By Cristina Poza Gomez – Regulatory Affairs Associate – and Milagros Ramos – Regulatory Affairs Team Lead

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How biosimilars open the door to advanced medicines in LATAM