Since 2010, things have really changed for the pharmaceutical industry worldwide due to a wave of generics that has splashed into the market. These days, the next big wave in the sector is expected to come from the expansion of biosimilars because several patents of the main biotechnological products have expired or are set to expire in the short-term.
The nation’s pharmaceutical sector makes 1.2% of GDP and, according to IMS Health, a company that provides information for the worldwide healthcare industry, the production of biotechnology medicines in Mexico is growing at 3.8 % annually, twice that of the global market that grows at 1.5% per year. Currently, some big pharma firms that develop biotechnology (Boehringer Ingelheim, Amgen, and Roche, among others) have plants in Mexico, but some local companies such as Probiomed and Laboratorios Cryopharma are getting stronger in the production of biosimilars in the country. Up to now, there are nearly 10 laboratories that develop biosimilars in Mexico.
A biosimilar is a copy of an original biotechnological medicine that is developed by a different firm. They are very similar to the original product and both medicines must be comparable in terms of safety, quality, and therapeutic equivalence. The idea is analogous to a chemically-produced drug and its generic, but biosimilars pose certain specific challenges for their production.
In particular, biopharmaceuticals are produced by using a biotechnical process within living cell culture, which makes their developing and manufacturing process longer, more expensive, and demands a more strict regulation than generics. According to IMS health, the clinical development cost for biosimilars ranges from $40 to $300 million. On the other hand, the estimated cost for a generic ranges from $1 to $4 million.
Biosimilars are on the rise, and the authorities are starting to intervene and tailor a robust regulation on the matter. Mexico started in the 90s to regulate biotechnology and has added some new articles to the legal framework since then. The most significant change took place in 2015 with the passing of the Norma Oficial Mexicana (NOM) 257, which has been welcomed by the industry. The NOM 257 ensures that the production of biotechnological medicines brings modern, efficient, and high quality biosimilars into the market.
In an interview with TBY, the President and General Director of Boehringer Ingelheim México, Miguel Salazar, said that the regulation is “not perfect,” although it is clearer than the previous one and it is an important step to come up with a “further harmonized regulation.”
“It is already a benchmark in Latin America and I would dare to say it is close to the European Medicines Agency (EMA) regulation,” said the Deputy General Manager of Probiomed, Sandra Sánchez y Oldenhage. According to Sánchez, this new regulatory framework is a game changer that will guaranty the similarity to the reference products. “With the new NOM 257, innovative biopharmaceuticals and biosimilars will coexist in the Mexican healthcare system while ensuring product efficacy and patients,” she added.
Nevertheless, Sánchez claimed that the Mexican pharma sector has to improve in terms of infrastructure. For instance, the executive pointed out that a “full characterization study” for the biosimilar product is needed for approval by the regulator but there is “no local supplier” that can do that. “Mexico still needs to develop its infrastructure capabilities in the area of biotechnology and that will take time,” she said.