RIO DE JANEIRO – Brazil is increasingly looking to put more resources into biotechnology, recognizing the great prospects. But it has to catch up in terms of technology and drug development.
"The idea is to invest about $600 million in the following five years. . . . The idea is that five years from now, we can have a proper compound produced in our facilities," said Renato Faro, research, development and innovation manager at Bionovis in Brazil. Bionovis is a national 2012 joint venture formed by Aché, EMS, Hypermarcas and União Química aiming to take a piece of the Brazilian biotech market share by developing its own compounds.
"The best way to reduce this gap on tech is to get tech from abroad, and based on the tech transfer we can incorporate the tech and train the technicians in Brazil," he said.
The returns could be quite significant. In 2010, biopharmaceuticals accounted for 3.7 percent of the pharmaceuticals distributed in the country, but they took a much larger 32 percent share of public procurement in the Latin American country.
To secure the growth of this particular sector, regulators and industry executives gathered in Rio de Janeiro for the BIO Latin America 2014 conference to consider updates to the legal framework, stay ahead of changes to regulation and consider ways for biologics and biosimilars to gain market share.
One key goal for both regulators and the industry in developing biotech markets like Brazil is to set up the right safety margins for the biopharmaceutical industry, said Andreas Baumann, director and principal scientific expert for biologics within global early development, at Bayer Schering Pharma, of Berlin, part of Bayer AG.
The concern for most regulators across the region is to be part of an ongoing effort to harmonize global processes, said Baumann.
"Are we aligned?" he wondered when discussing such topics as nonclinical species selection, dose extrapolation to humans and carcinogenicity assessment.
In general terms, said Baumann, domestic authorities in Latin America are increasingly willing to accept nonclinical submissions conducted in accordance with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) standards on preclinical safety evaluation of biotechnology-delivered pharmaceuticals, nonclinical evaluation for anticancer pharmaceuticals and guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals.
Regulators are also increasingly following World Health Organization´s (WHO) guidelines on rDNA products.
BIOSIMILARS NAMING, INTERCHANGEABILITY SPUR DEBATE
In any case, Brazil is an active participant in a global discussion, one that regulators have been tentative about addressing. There are a number of issues at the heart of this discussion, including the growing market and role for biosimilars.
"The [FDA] itself has been engaged for the first time in delivering a biosimilar pathway, and how it is going to be executed is not very clear," reminded Joseph Damond, senior vice president of International Affairs at BIO.
This global discussion has a very real impact in most countries, including Brazil. A key discussion is around naming.
"One concern is the name [that should be used] for biological and biosimilars, and the question is if we would have to provide the names based on the originators or if we need to have brand names," said Marite Prieto, regulatory affairs, safety and compliance director at Amgen in Brazil.
She wondered how a company could develop a system of pharmacovigilance on a certain medication if "a kind of generic biologic" becomes common place.
Another hot topic of discussion at the conference this week is the interchangeability problem.
"Each biosimilar is unique, but for most of the people, at least here in Brazil, if you have a prescription written, the hospital is changing it based on costs," said Prieto.
Brazil's biotechnology industry shares some of the concerns.
According to established pricing, substitutes are 34 percent cheaper than innovators, said Prieto.
"We need to understand that it will not happen the same with biosimilars," she said.
But not all consider this particular issue a huge problem.
Faro, of Bionovis, said interchangeability is not a great concern. He explained how tech transfers are helping move this public initiative forward.
"We need to discuss this with physicians, with the patients, but I don't think it would be a huge problem," he said.
"Sometimes it is difficult for people to understand how regulations work in Brazil. . . . Brazil´s surveillance agency of the Ministry of Health (Anvisa) is a teenager, not a 100-year-old lady like the U.S. FDA or the EMA," said Prieto. "In 2002 we had the first regulation for biologicals in Brazil."
"Since the concept of biosimilars in Brazil was born, it has been a very hot topic in the country. We need to understand how to deal with them, how to handle them and how to bring the best of biosimilars to our population," Prieto said.
Anvisa has just hired more than 300 new employees to support the ongoing changes.
"It was difficult for us to understand and new legislation to digest it by pharma companies, and we need to understand what makes sense in terms of efficacy, safety and the quality of the products," she said.