CAJICA, Colombia – The Latin American biotech sector is scrambling in the midst of the COVID-19 pandemic, not only in coping with the outbreak, but also in finding the path to the future, while avoiding the pitfalls and looking for new opportunities ahead.

Stakeholders in the region have started discussing the region´s biotech future, even as events like BIO Latin America in Sao Paulo, Brazil, have been called off as a result of the outbreak.

Last week, Cristian Madoery, life science director for Latin America at Clarivate, of Philadelphia, hosted the webinar, titled “Biologics & Biosimilars: Challenges and Opportunities in Latin America,” in which a group of experts shared their points of view regarding the future of the sector in the region. (BioWorld is published by Clarivate.)

“Beyond the health problem, things will become difficult in relation to the economy in these countries. I believe that a rampant recession is coming for Latin America,” said Paulo Etcheverry, regional manager for Colombia, Venezuela and Central America at Laboratorio Siegfried, a division of Roemmers Group, from Buenos Aires, Argentina.

“Everything related to biologicals and biosimilars depends, at the end of the day, on the economic system. And the system thrives on contributions, and contributions are nourished by jobs, so all this is going to look greatly affected,” he explained.

Latin American will see its economy dropping by 8% in 2020, according to the United Nations Economic Commission for Latin America and the Caribbean (ECLAC), as a consequence of the pandemic and the lockdowns implemented by most of its governments.

The economic crisis will deepen the discussion on biosimilars, patents, and regulatory processes and approvals across the region.

“Biologicals have arrived in Latin America and biosimilars have also arrived as a necessity for the health system,” said Eduardo Spitzer, scientific and regulatory affairs director at Laboratorio Elea Phoenix, of Buenos Aires, Argentina. “In a globalized world, it is difficult to be not tuned into what is going on in the rest of the world.”

Whether governments should prioritize the approval and use of biosimilars over biologicals, in view of public expenditure and tight budgets, will be a key topic of discussion in the next few months. Regulatory agencies will play a central role as part of the governments that need to spend wisely.

“It's been almost two decades since we started this controversy and the debate, and it was all about the question if governments can or cannot relax the marketing authorizations, and I believe there is the center of the discussion,” said Etcheverry.

“I believe that the problem why there are not more biosimilars in Latin America is regulatory – the regulatory barriers,” he said.

Mayra Pérez, executive director at the Unity of Development of Research and Medical and Biotech Innovation (UDIMEB) at the National School of Biological Sciences from the National Polytechnic Institute, from Mexico City, said she shares the same view as Etcheverry. It all comes down to regulations and health surveillance agencies.

“At the beginning, it is a challenge, but then it turns into an opportunity so that countries can implement, not the importing, buying of biosimilars, or their approvals, but the opportunities for the development and establishment of the technology in Latin America,” she said.

According to Clarivate´s databases, there are 9,666 patents related to 486 biotech products in Latin America. Mexico, Argentina, Uruguay and Brazil are some of the countries taking the lead when it comes to biotech research and development.

“Without any doubt, in Mexico innovation is booming...at the institute we’ve got zero developments in biosimilars, but 15 in innovators,” said Pérez.

“Particularly, in Mexico there's a new window of opportunity for the development of biotech, of new molecules, of innovation given the experience that we’ve had with biosimilars,” she added. “This is happening in my country; however in Latin America, definitely capacities of innovation and development are not the same across all countries, and experiences and needs are also not the same.”

Tech transfer: A possible way out?

The possibility of having tech transfer operations in Latin America and within the region is a hot topic of discussion. Some think that is a good way of moving forward the biotech sector in the region.

“It is not only possible, but it is the vocation of Latin America,” said Francisco Kuri Breña, independent consultant at FKB Consulting, from Mexico City. “Although it is possible to create innovation, it is not a reality; we are more generally of the ‘me too’ type, and that is what can be achieved with the transfer of technology.”

However, the role of governments and public-private partnerships, such as those taking place in Brazil, are and will be key for technology transfers to succeed in the biotech sector.

“To take advantage of these technologies, and to have real tech transfers, the states have to contribute, the governments have to contribute, because in our countries, and in some more than in others, the policies to promote biotech are in place through laws,” Etcheverry said. “They are law in Colombia, in Argentina, in Brazil, which is at the forefront through the partnerships ... it is important to understand that these products and these projects require so much investment, that this frequently is a natural barrier for any entrepreneur or innovator.

“That would be a goal, and an ideal, and also the necessary underpinning,” he said.

The biotech sector after COVID-19

As with many sectors around the world, uncertainty is the default setting during the outbreak. What will follow the pandemic for the biotech sector in Latin America?

FKB’s Kuri Breña is not very optimistic. “I see it staying the same. We are stuck in this. Of course, for the COVID-19 issue, it is an emergency, and everything related to solving it will be favored, but for the rest of the biosimilars, it will be just the same, and it will continue to be slow,” he said.

UDIMEB’s Perez is more optimistic on the outcomes of the pandemic, at least in Mexico. However, expectations are focused on COVID-19-related products, as Kuri Breña warned.

“The pandemic has restarted the focus needs and opportunities and services and research, which at our institute has grown about 40% during the pandemic,” said Perez. “And this momentum is driving Mexico to try to establish its own technology, to, at least, compete with antigens, compete with antibodies, provide support in the current situation, and it is an opportunity for the focus on technology to stay,” she said.

“I see a promising future ... I see a great opportunity for Mexico that is available right now, which is interesting,” she added.

Etcheverry also sees the momentum as an opportunity to foster innovation in the region.

“Biosimilars will not see a stoppage of approvals due to [COVID-19], and I believe that this is a good moment for the government to encourage entrepreneurship from within, to promote innovation on small, medium and large scales,” he said. “It also is up to the governments to use all the tools and flexibility that they have to modify and adapt legislation, and in specific, their regulation, to their national realities.”

No Comments