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.

Tackling regulatory challenges

While there have been efforts to harmonize drug registration processes through the Pan American Network for Drug Regulatory Harmonization (PANDRH), country-specific documentation and critical differences between countries remain. This means that, unlike the EU where biotech products are approved under the centralized procedure for marketing approval across all 27 countries, in LATAM each marketing authorization application goes though different national procedures in each country in the region.

Common challenges that pharmaceutical and biotech companies alike face when seeking marketing approval in LATAM are the frequent changes in guidelines, grey areas and the fact that the regulations are not easily accessible or easy to understand. Usually, big companies have an affiliate in the region, but for smaller companies this is not feasible, especially in the smaller LATAM countries.

Lack of local presence is a problem for companies since the health authorities communicate through face-to-face meetings. Furthermore, all exchanges are conducted in local language and each country has a different culture and way of working. Diplomacy and negotiating skills are vitally important when working with these countries.

Harmonizing labeling for a product can be difficult given that some markets require different languages or more than one language, and because of the specific local requirements, particularly in the smallest markets, such as the Dominican Republic, Jamaica, Curacao, and Belize.

Additionally, authorities are usually slow to respond due to  heavy  workloads, which makes it difficult to manage changes in  the product  and the supply chain.

New products, new challenges

For biological products there are  additional difficulties to consider.  First, most LATAM countries do not accept a fast-track procedure for biotech products. Additionally, health authorities have far more requirements to register biotechnological products, which results in longer review timelines for initial registration and life cycle management activities. Some products, such as vaccines, face even stricter controls and must undergo post-marketing surveillance to receive approval.

In addition to this, regulatory authorities have limited resources and lack the specialized expertise to evaluate biotech products. To address this barrier, some countries such as Argentina, Chile, and Brazil have created specialist biotech degrees at national universities, as well as technological transfer units to build a network of experts to liaise between the industry, universities, and research institutions.

There are other logistical challenges for companies. For example, some countries require local testing, which means companies need to either have an equipped quality control (QC) laboratory within its affiliate, or outsource the service to an accredited QC laboratory and invest in analytical methodology transfer.

While this is also required for small molecule medicinal products, biological products require high-tech equipment and trained personnel. These kinds of facilities can be difficult to find in most LATAM countries, and establishing such a service is costly. Finally, this testing requirement has an impact on launch timelines, since in some countries the product cannot be released without an appropriate QC analysis.

Considered market entry

While LATAM is an attractive region, offering exciting business development opportunities to the biotech industry, companies need to evaluate the feasibility and the costs of any prospective market. Considerations should include:

  • What are the regulatory costs to obtain and maintain MA?
  • Is local testing required?
  • Is it possible to have shared packaging in different LATAM countries?
  • Are local clinical trials or special post-marketing surveillance activities required?

Working with partners who have local presence and knowledge of each LATAM market, and who have built a collaborative relationship with the health authorities, is key to gaining a realistic understanding of the market potential, cost of working in these markets, and the time it will take to bring innovative products to each market.

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Regulating Biotech Products in the Complex LATAM Region