Medicamentos biocomparables en México: la postura del Colegio Mexicano de Reumatología, 2012

Morales, Rolando Espinosa; Borjón, Alejandro Díaz; Fabris, Leonor Adriana Barile; Esquivel-Valerio, Jorge Antonio; Ramírez, Gabriel Medrano; Salinas, César Alejandro Arce; Mercado, Eduardo Rubén Barreira; Cardiel, Mario H.; Jouanen, Efraín Díaz; Murrieta, Francisco Javier Flores; Mouret, Antonio Fraga; Elizondo, Mario Alberto Garza; Estrada, Miguel Luján; Barradas, Francisco José Muñoz; Piña, Juan Osvaldo Talavera; Vera‐Lastra, Olga

doi:10.1016/j.reuma.2012.11.001

Cited by 13 publications

(4 citation statements)

References 4 publications

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“…COFEPRIS also issued rules for noninnovator biologicals registered prior to October 19, 2011 (when the guidelines for biocomparable medicines were first published), mandating that companies marketing these products conduct clinical trials to establish biosimilarity and submit their data to the commission. 37 The Mexican College of Rheumatology also published a position paper on biosimilars regulation, 38 voicing their support for biosimilars development, provided they are subject to the highest standards of production and development, including adequate clinical studies, and followed by a strict pharmacovigilance program. The infliximab biosimilar Remsima was the first biocomparable medicine approved following the full procedure required by the COFEPRIS, 39 and the manufacturers of future biosimilars will likely be required to follow this path.…”

Section: Regulatory Pathways To Biosimilarity: a Snapshot Of Latin Ammentioning

confidence: 99%

Practical Guidance on Biosimilars, With a Focus on Latin America

Azevedo¹,

Babini

Caballero-Uribe

et al. 2019

J Clin Rheumatol

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Practicing rheumatologists in Latin America need to understand the regulatory situation for biosimilars in their countries. When considering bDMARDs that are not innovator products, clinicians should use only those that have been approved according to the WHO recommendations. For clarification, local health authorities or professional associations should be contacted.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

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Section: Regulatory Pathways To Biosimilarity: a Snapshot Of Latin Ammentioning

confidence: 99%

Practical Guidance on Biosimilars, With a Focus on Latin America

Azevedo¹,

Babini

Caballero-Uribe

et al. 2019

J Clin Rheumatol

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“…By 2011, this policy had resulted in 23 intended copies of biologics registered in Mexico as generics [ 18 ]. The Mexican College of Rheumatology in 2012 published a position paper regarding the necessary scientific evidence required to evaluate the efficacy and safety of biosimilar drugs before and after their arrival to the Mexican market [ 55 ]. A warning to health professionals was issued by the Mexican Federal Commission for Protection Against Health Risks concerning anaphylactic reactions associated with rituximab when the originator product rituximab and the intended copy Kikuzubam ® were interchanged [ 56 ].…”

Section: Evolving Regulatory Landscapementioning

confidence: 99%

“…In the interim, biosimilars will be identified by the Australian biologic name without a specific biosimilar identifier suffix [ 75 ]. The Mexican College of Rheumatology states that the label of each biologic product should clearly indicate whether it is an innovative biologic or biosimilar drug [ 55 ]. In Europe, approved biosimilars share the INN that corresponds with that of their reference product, and EMA advises that the commercial name, appearance, and packaging should differ.…”

Section: Biosimilar Namingmentioning

confidence: 99%

Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology

Mysler¹,

Pineda

Horiuchi

et al. 2016

Rheumatol Int

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Biologics are vital to the management of patients with rheumatic and musculoskeletal diseases such as rheumatoid arthritis and other inflammatory and autoimmune conditions. Nevertheless, access to these highly effective treatments remains an unmet medical need for many people around the world. As patents expire for existing licensed biologic (originator) products, biosimilar products can be approved by regulatory authorities and enter clinical use. Biosimilars are highly similar copies of originator biologics approved through defined and stringent regulatory processes after having undergone rigorous analytical, non-clinical, and clinical evaluations. The introduction of high-quality, safe, and effective biosimilars has the potential to expand access to these important medicines. Biosimilars are proven to be similar to the originator biologic in terms of safety and efficacy and to have no clinically meaningful differences. In contrast, “intended copies” are copies of originator biologics that have not undergone rigorous comparative evaluations according to the World Health Organization recommendations, but are being commercialized in some countries. There is a lack of information about the efficacy and safety of intended copies compared with the originator. Furthermore, they may have clinically significant differences in formulation, dosages, efficacy, or safety. In this review, we explore the differences between biosimilars and intended copies and describe key concepts related to biosimilars. Familiarity with these topics may facilitate decision making about the appropriate use of biosimilars for patients with rheumatic and musculoskeletal diseases.

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“…Although the nature and extent of supporting data differ somewhat among regulatory agencies, approval is based on the totality of the evidence. Several national academic organizations, such as societies, colleges, and associations, have also provided position statements on the approval processes for and clinical use of biosimilars [ 8 – 14 ]. These recommendations encourage stringent standards for biosimilar approval and post-marketing pharmacovigilance, and for extrapolation of efficacy and safety data for other indications for which the biosimilar has not been investigated in clinical trials.…”

Section: Introductionmentioning

confidence: 99%

Assessing the Immunogenicity of Biopharmaceuticals

et al. 2016

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Biopharmaceuticals have the potential to raise an immunogenic response in treated individuals, which may impact the efficacy and safety profile of these drugs. As a result, it is essential to evaluate immunogenicity throughout the different phases of the clinical development of a biopharmaceutical, including post-marketing surveillance. Although rigorous evaluation of biopharmaceutical immunogenicity is required by regulatory authorities, there is a lack of uniform standards for the type, quantity, and quality of evidence, and for guidance on experimental design for immunogenicity assays or criteria to compare immunogenicity of biopharmaceuticals. Moreover, substantial technological advances in methods to assess immune responses have yielded higher immunogenicity rates with modern assays, and limit comparison of immunogenicity of biopharmaceuticals outside of head-to-head clinical trials. Accordingly, research programs, regulatory agencies, and clinicians need to keep pace with continuously evolving analyses of immunogenicity. Here, we review factors associated with immunogenicity of biopharmaceuticals, potential clinical ramifications, and current regulatory guidance for evaluating immunogenicity, and discuss methods to assess immunogenicity in non-clinical and clinical studies. We also describe special considerations for evaluating the immunogenicity of biosimilar candidates.

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Medicamentos biocomparables en México: la postura del Colegio Mexicano de Reumatología, 2012

Cited by 13 publications

References 4 publications

Practical Guidance on Biosimilars, With a Focus on Latin America

Practical Guidance on Biosimilars, With a Focus on Latin America

Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology

Assessing the Immunogenicity of Biopharmaceuticals

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