Biological Medications Require Special Protocol

Translated by Stacey Schlau, a CSN volunteer translator

Edited by Nora Walker

Normally, bio-pharmaceuticals are brought into this country without specification that they are alternatives that require strict supervision. Colombian law regarding this issue is weak.

Julio Delgado, member of the Generation Bio Foundation and co-author of the law that regulates the production of bio-technological medications within Colombia, stated that these kinds of drugs are the most expensive on the market and are responsible for the majority of recoveries to Fosyga.

“In 2008 alone, 6 of the 10 most recovered drugs belonged to this category, as the records of the Information System of the Prices of Medications demonstrate,” said the expert.

Advances in genetic and molecular biology have made possible the creation of biotechnological pharmaceuticals obtained with micro-organisms, cells, animals, plants, or other genetically modified living beings. Their complexity ranges from simple proteins, such as insulin, to large molecules.

According to international studies, once the patent expires the cost of the pharmaceutical is reduced up to 30%. The largest pharmaceutical laboratories are found in the U.S. and Europe, although emerging powers such as China, India, Korea, and Brazil are becoming competitive in this market.

Currently in Colombia, new bio-pharmaceuticals are registered as products, not as bio-similar entities. Laboratories bring all pre-clinical and clinical information to Invima for quality insurance under Law 6777 from 1995, which determines the necessary data for their registration and commercialization.

Nevertheless, María Teresa Reguero, pharmaceutical chemist of the UN, asserts that “bio-pharmaceuticals require an independent policy, which we does not exist right now. The Conpes document seeks to institute an independent article within this law dedicated to bio-pharmaceuticals.”

New policies are necessary because improper use of these bio-analogs entails several risks. “For instance, if the new medication does not have the same molecular structure as the original, its structure will be unique and therefore will lead to secondary effects or even death. Bio-pharmaceuticals that are used for long periods of time may create immunogenicity, in other words, antibodies,” Reguero emphasized.

The debate about the lack of regulation of these drugs re-opened this week because of the number of patients who petitioned the Ministry of Health and Social Welfare for more regulation because they believe the draft of the law regulating access to these drugs is not strict enough. They claim that regulation does not conform to international standards.


February 9, 2012


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