Marlene Llopiz-Aviles, international strategy and regulatory affairs director in Mexico City, told attendees at CPhI Worldwide on Tuesday that among the top five markets – Argentina, Brazil, Chile, Mexico and Venezuela – Argentina, Brazil and Mexico stand out as the leaders.
Llopiz-Aviles noted the uptake of biosimilars, however, began initially with barely any regulations in place.
“They’re here, they’re now, and it’s a train and it’s going,” she told attendees.
Both Venezuela and Chile have yet to establish regulatory guidelines for biosimilars, though it seems both countries will look to EU and WHO regulations as an example. Venezuela is also the only one among the top five that doesn’t have any local production capacity, which makes them more expensive than elsewhere because they have to be imported.
“They’re behind but they’ll catch up,” Llopiz-Aviles said in reference to Venezuela.
Argentina, however, which first adopted embraced biosimilars more than a decade ago, is setting the bar for how other countries in the region should regulate them, she siad. The country has even gone so far as to invest 20m Argentinian pesos in an effort to develop monoclonal antibodies at lower costs.
For Brazil, characterization of the biosimilars seems to be one of the biggest regulatory issues, she said, noting that safety is probably the only bigger issue. “One major safety issue could change physicians’ mind” in Brazil and elsewhere, she said, comparing the uptake of biosimilars to the initial wariness physicians had with generics.
Mexico, meanwhile, has a more complicated set of regulations that are “very vague on purpose,” with all sorts of “loopholes” in the law that depend on the company’s presentation to a government commission. She also noted that next week Mexico will hold another meeting to discuss the country’s second iteration of biosimilar regulations, which should be more mature than the first version.
Argentina has similarly gone through two iterations of its regulations for the follow-on biologics.
Biosimilars in Mexico are also “much cheaper” than in Brazil, she noted, adding the cost is mainly due to their uptake in government programs in Mexico, she told BioPharma-Reporter.com.