Biocomparable Drugs in Mexico: Challenges and Opportunities in the Treatment of Gaucher Disease

Abstract:
Biotechnological drugs are complex molecules, whose manufacturing hinders an identical replication of the original substance; thus, there is not an absolute equivalence between the original drug (innovative) and the biocomparable one. Several biotechnological drug patents have expired or will expire soon, which enables the development of drugs with presumably similar structure, efficacy and safety to innovative drugs; however, that must be demonstrated. Current Mexican General Health Law ponders registering these drugs to be used in our country, but Group of Experts on Gaucher Disease claims there is a “regulatory gap” with respect to biotechnological orphan drugs. Enzymatic replacement therapy is the election treatment for Gaucher Disease; Cerezyme™-imiglucerase has been available in Mexico for ten years to treat it; there is evidence supporting its safety and efficacy. Asbroder™ (Abcertin™) was given recognition as an orphan drug; its trading was approved in our country by its international name, imiglucerase. This document is based on the expertise of clinical physicians, pharmacologists, and researchers about situations and evidence that should be considered in the enzymatic replacement therapy and new drugs with the same international non-proprietary name for Gaucher Disease treatment. The objective is guaranteeing the accomplishment of therapeutic goals and maintaining the patients’ safety.

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Source URL: http://gabi-journal.net/biocomparable-drugs-in-mexico-challenges-and-opportunities-in-the-treatment-of-gaucher-disease.html


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