Filgrastim is widely used in Mexico, as in other countries. Its patent has expired and hence several non-originator biologicals have appeared. Following WHO guidelines, the General Health Law of Mexico was modified in 2009 to provide a solid regulatory environment for biosimilars (or biocomparables as they are called in Mexico) [1].
Mexican regulations establish that a stringent pharmacovigilance programme is necessary for biopharmaceutical products, both biocomparables and originator biologicals. Notwithstanding, the issue of traceability has not yet been fully solved. In the Mexican social security system, medicinal products are identified by codes, with originator biologicals and biocomparables receiving the same code. Evidently, pharmacovigilance studies must adapt to this situation, as it is not likely that the coding system will be changed in the near future. It is therefore required to design suitable strategies to allow for the collection of sound pharmacovigilance data for originator and biocomparable biopharmaceuticals, including filgrastim.
With this purpose in mind, a prospective, non-interventional, descriptive, pharmacovigilance study of different filgrastim products provided at the National Cancer Institute of Mexico was carried out [2]. The study included giving diaries to patients to record adverse drug reactions (ADRs), as well as examination of clinical histories. The protocol was approved by the National Pharmacovigilance Center.
Filgrastim was mainly dispensed as three non-originator products. Six hundred diaries were given to 373 patients. A total of 368 diaries were returned by 221 patients. In 93% of the cases it was possible to trace drug name, expiration date, brand name and batch number of the dispensed products. ADRs were experienced by only 45% of the patients receiving filgrastim. All recorded ADRs had been previously reported. Twenty-eight patients received more than one brand of filgrastim during their treatment, despite the fact that switching is not recommended at this time in Mexico.
The authors concluded that their approach allowed good quality ADR and traceability information on filgrastim to be obtained. They added that the present study shows that robust pharmacovigilance studies can be performed in Mexico complying with current regulations for biopharmaceuticals using the patient diary approach. Moreover, confrontation with clinical files reduces the risk of bias by subjective patient perception.
Conflict of interest
The authors of the research paper [2] did not provide any conflict of interest statement.
Abstracted by Dr Mireya López Gamboa of the Department of Pharmacology, Cinvestav and the National Cancer Institute, Mexico.
Editor’s comment
It should be noted that biocomparables approved in Mexico might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.
Readers interested to learn more about biocomparables in Mexico are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Recommendations for the regulation of biosimilars and their implementation in Latin America
Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Mexican guidelines for biocomparables [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 16]. Available from: www.gabionline.net/Guidelines/Mexican-guidelines-for-biocomparables
2. Huerta-Sánchez OM, Aguilar-Ponce JL, Meneses-García A, Herrera-Gómez A, Herrera-Hernández R, et al. Implementation of a robust pharmacovigilance method for filgrastim non-innovator products in cancer patients in routine clinical practice complying with mexican regulations for biocomparables. J Pharmacovigil. 2015;3(4):174. doi:10.4172/2329-6887.1000174
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