Stengthening Guidelines for Biosimilars
Despite being in the Mexican market for over twenty years, biosimilars have never been regulated as a separate entity. They have always been regulated as simply another category of generic medicines.
“This enabled almost unmonitored competition from China, India, South Korea and other fast-growing countries, which sometimes caused more damage than good to the patient,” explains Jaime Uribe, CEO of Mexican biosimilar company Probiomed.
“This is the reason why biosimilars started to be regulated much more closely… and after five years of negotiations the law was finalized,” he continues. The Mexican guidelines for the approval of biotech and biosimilar drugs became effective in April 2012.
Dr. Ana Cristina Mirassou, director of biotechnology in Jalisco-based company, Grupo IFACO, tells us how this lack of tight regulation affected the launch of their first biotechnology product.
“There has been some turmoil around biotech regulation in Mexico, and for a long time, the authorities were uncertain as to which requirements to ask for in a new biotech product. Companies who were able to register their products before this turmoil were granted the registration in about six months, whereas we had to wait three years.”
According to BMI figures, Mexico’s biopharmaceutical sector currently employs almost 25,000 Mexicans in more than 32 biotechnology companies. Biotechnology is also becoming more of a priority for many States in Mexico when compared to traditional pharmaceuticals.
“The governor of Jalisco declared biotechnology as one of the key strategic industries for the state. He sees bio-technology as the future,” Mirassou says.
Uribe adds, “Half of new innovative drug registrations given here in Mexico are for biotechnology products: the world is looking to biotechnology and companies are invest-ing more and more every day.” Indeed, Mirassou sees Grupo Ifaco’s biotechnology center as the main growth driver for the group, and concludes:
“Mexico is emerging as an important hub for the production of biotechnology products. Once we have our legislation in order, we will be extremely competitive, not only inside Mexico, but internationally.”