November 2021 Monthly Newsletter

The growth of the Latin American biotech market and expiration of biotech patents has pushed national regulators to adopt a different approach to regulating biotech products compared with synthetic products.

By their very nature, biological products present more challenges than classic synthetic medicines.  These challenges are even more difficult to address in such a diverse region as LATAM, which comprises more than 30 countries with different socio-economic and culture realities.

At the same time, however, there has been growing recognition of the importance of biotech products in the region, particularly in the wake of the COVID-19 pandemic with the development of biotech medicines to manage the virus. Authorities also increasingly recognize the economic potential from encouraging scientific development of new immunotherapies within LATAM markets. First, though, they must overcome both existing and new regulatory barriers.

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.

Brazil’s regulatory authorities have been busy updating regulations and streamlining processes with the purpose of better managing products sold in the country.

In one example, the Brazilian health agency, Anvisa, has made some important changes to the active pharmaceutical ingredient (API) evaluation procedure. In the past, the API dossiers, known as the drug master file (DMF), were integrated the marketing authorization application dossier and had to be individually analyzed by Anvisa each time they were submitted. As a result, Anvisa sometimes performed several evaluations for the exact same API, used in different products. However, after August 2023, the dossier for APIs will need to be submitted separately by their manufacturer to obtain a suitability certificate (known as the CADIFA), which means, in future, Anvisa will only need to analyze an API once, even when used by different companies. This will bring Brazil in line with processes in other major markets, such as the EU.

Every year, competent authorities in the EU grant numerous new marketing authorizations for medicinal products. As an example, in 2020, the European Medicines Agency (EMA) recommended 97 new medicines and 39 new active substances for authorization.

Although the process for obtaining marketing authorization is widely documented through guidances and directives on health authority websites, the launch process is not centrally described and local requirements may vary from one country to another. This is a challenge for pharmaceutical companies, which have gone through a complex registration process and want to launch their newly registered medicinal products as soon as possible.

Turkey has been on a mission to update and clarify its regulatory guidelines in an effort to improve and streamline processes for companies and regulators.

In mid-September 2021, the Turkish Medicines and Medical Devices Agency of the Ministry of Health (MoH) released its updated guidelines on biosimilar products, providing more detailed information for companies looking to bring their products to market in Turkey. The previous version, which was issued in 2008, provided sparse details for companies, and largely referred to the European Medicines Agency (EMA) guidelines. However, it should be noted that the new guidelines don’t offer the detailed product-specific guidelines on biosimilars that the EMA has published.