Latin America Roundup: Brazil, Mexico launch efforts to ease biosimilar regulation
In recent weeks, both Brazilian and Mexican regulatory authorities have made public their eagerness to spur domestic production – and faster regulation – of biosimilar drugs, with each country hoping to both reduce its own dependence on high-cost imported biologic agents and emerge as an important regional exporter of lower-cost therapies.On 27 September, officials with Brazil’s National Health Surveillance Agency (ANVISA) announced a public comment period concerning a proposed rule change that would, if adopted, ease the path by which biologic and biosimilar drugs receive marketing authorization. The announcement followed two recent conferences by ANVISA to engage stakeholders, in which the agency “reviewed the pros and cons of waiving the non-clinical and clinical studies requirement when reviewing marketing applications for biosimilars, interchangeability, and international references,” wrote Sao Paolo attorney and sector analyst Benny Spiewak in a 28 September column for Lexology. The move was not unexpected: ANVISA had stated in an August 2022 report that regulatory reliance would be central to its strategy to increase production and availability of biosimilars.
Also writing in Lexology, Licks Attorneys of Rio de Janiero weighed in on the proposed changes, noting that they reflect concerns raised by biosimilars manufacturers during preliminary meetings, such as allowing for the purchase of reference products on the international market, which current norms restrict.
On 28 September, Mexico’s Federal Commission for the Protection against Health Risks (COFEPRIS) announced its own ambitious initiatives on biosimilars, some of which were previously detailed in its most recent Regulatory Certainty Strategy white paper. The announcement described a proposed modification to existing law that would, if adopted, allow for reliance on comparative clinical studies conducted outside Mexico, and the decisions of certain foreign regulators, for new registrations of biosimilar products. It would also create new pathways to facilitate local production.
Mexico health analyst Maribel Ramírez Coronel had earlier revealed specifics about the agency’s biosimilars strategy in a 17 September column for the newspaper El Economista. In addition to seeking regulatory reliance for foreign-manufactured products, COFEPRIS has lately convened working groups with major Mexican pharmaceutical manufacturers and investors to outline plans for the development of a national biosimilars industry, building on Mexico’s success as a generics producer, Ramírez Coronel wrote. The plans are expected to be submitted to agency head Alejandro Svarch Pérez in mid-October for review.
The plans include creating a unit within COFEPRIS dedicated to biosimilars, and the reconvening of the agency’s pharmaceutical development committee, not unlike the agency’s scientific advisory committee that was recently revived after years of inactivity. Identifying molecules of interest for Mexico will be a top priority of COFEPRIS, as will authorizing more entities in Mexico to conduct biocomparability studies.
Brazil and Mexico appear to be on parallel tracks to position themselves as not only self-sufficient in biosimilars, able to supply their own large national health systems with cheaper alternatives to costly monoclonal antibodies and other classes of biologics, but major regional suppliers as well. Mexico may take advantage of its proximity to the United States to export Mexican-made biosimilars, Ramírez Coronel wrote in her column.
Brazil’s ambitions for biosimilar production also go well beyond its borders, Benny Spiewak said in an interview with Focus. “The idea is not only for Brazilians to use Brazilian-manufactured drugs, which would be cheaper, but to export them to countries like Argentina, Paraguay, Uruguay, and Suriname, and also Portugese-speaking countries in Africa, with which Brazil has built a lot of influence. We have millions of people who will eventually be buying Brazilian-made products,” Spiewak said.
The move comes, Spiewak commented, with a loosening of Brazil’s traditional reticence to regulatory reliance. “There is kind of a common understanding here that Brazil failed to jump on the basic pharmaceuticals train but does not miss the chance when it comes to biologics,” Spiewak said. “ANVISA is doing whatever it can to adapt and update and make more straightforward the regulations on biosimilars and biologics.”
“As we speak, we are expecting the executive branch to issue new regulations on public-private partnerships on pharmaceuticals and biologics,” Spiewak added. “So from a practical market perspective, companies should be ready to dialogue with the Brazilian government. The government is sending a clear message that it does not just want to be the buyer for these products anymore. The government wants to have some sort of a connection [to their development].”
ANVISA will accept public comments on its website from 11 October through 24 November.
ANVISA Press Release (Portugese)
COFEPRIS Press Release (Spanish)
Colombia’s INVIMA marks a year without a director; absence felt in food vigilance
An investigation by the Spanish newspaper El País alleges that Colombia’s National Food and Drug Surveillance Institute (INVIMA) has not made routine inspection visits to certain remote regions of the country for a year. The newspaper attributed the suspension of activities to INVIMA’s lack of a confirmed director, who must be formally named by the executive branch.
INVIMA’s acting director, Mariela Pardo, took her post on 23 March after the surprise departure of epidemiologist Francisco Rossi, who was never confirmed in the post during his 8 months as acting director.
The El País article pointed to special concerns about food regulation. “In many regions of Colombia there has been no sampling to verify food quality for more than a year,” Colombian epidemiologist José Gonzalo Sánchez told the newspaper. The agency has reportedly also suspended labeling new products under Colombia’s junk-food law of 2021, which requires clear warnings on foods deemed excessively high in saturated fats, sugars and salts.
El País article (Spanish)
Chile’s ISP orders erroneous mass withdrawal of one manufacturer’s products, causing chaos
On 28 September, Chile’s Public Health Institute (ISP) announced that it had ordered the immediate suspension of all products from the Chilean manufacturer Laboratorio Sanderson, citing contamination with Burkholderia cepacia (BCC) bacterial species identified during a routine inspection. The next day the agency revised its action, clarifying that the withdrawal was limited to specific lots of a single product, a sodium chloride solution.
Laboratorio Sanderson is a major supplier of medical and surgical products in Chile, and the ISP’s initial announcement resulted in 24 hours of chaos in the healthcare system, according to Chilean news reports, with surgeries suspended and treatments postponed across some 20 medical centers.
Medical societies slammed the agency’s actions, and Chile’s health minister, Ximena Aguilera, on 2 October ordered an investigation into the decision-making and communications process by the ISP.
Report in La Tercera (Spanish)