Recommendations for the regulation of biosimilars and their implementation in Latin America

Azevedo, Valderílio Feijó; Mysler, Eduardo; Álvarez, Alexis Aceituno; Hughes, Juana; Flores‐Murrieta, Francisco J.; Castilla, Eva María Ruiz de

doi:10.5639/gabij.2014.0303.032

Cited by 29 publications

(32 citation statements)

References 24 publications

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“…45 Because few Latin American countries had patent laws at that time, many of these therapies were intended copies of other biologics and were registered as generics. It has been reported that around 100 such intended copies existed at the turn of the millennium.…”

Section: Biosimilars In Latin America: Current Situationmentioning

confidence: 99%

“…It has been reported that around 100 such intended copies existed at the turn of the millennium. 45 Since that time, however, countries in Latin America have begun to develop and implement regulation specific to biosimilars.…”

Section: Biosimilars In Latin America: Current Situationmentioning

confidence: 99%

“…46–48 In general, the region is moving toward increasing standards of regulation, and the WHO guidelines have been adopted or used as a basis for guidance in several instances. 45,50 …”

Section: Biosimilars In Latin America: Current Situationmentioning

confidence: 99%

“…45 The Pan American Network for Drug Regulatory Harmonization’s Biotechnological Products Working Group, formed in 2010, recommended that the region follows WHO guidance, 45 but regulatory pathways currently remain inconsistent from country to country. Furthermore, requirements are not aligned with the WHO pathway in all cases.…”

Section: Biosimilars In Latin America: Current Situationmentioning

confidence: 99%

“…44,45 In Mexico, for example, there were 23 intended copies, or “biolimbos,” on the market before the country’s biosimilar guidelines came into effect, and the regulator COFEPRIS has requested that the manufacturers conduct assessments to demonstrate the biosimilarity of these agents and the corresponding originator products. 63 The WHO has issued guidance recommending a stepwise approach to reviewing all authorized biologics and identifying those licensed on the basis of data that do not meet current regulatory expectations.…”

Section: Biosimilars In Latin America: Current Situationmentioning

confidence: 99%

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Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

Scheinberg

Pineda

Castañeda‐Hernández

et al. 2018

mAbs

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Biological therapies have revolutionized the treatment of several cancers and systemic immune-mediated inflammatory conditions. Expiry of patents protecting a number of biologics has provided the opportunity to commercialize highly similar versions, known as biosimilars. Biosimilars are approved by regulatory agencies via an independent pathway that requires extensive head-to-head comparison with the originator product. Biosimilars have the potential to provide savings to healthcare systems and expand patient access to biologics. In Latin American countries, regulatory frameworks for biosimilar approval have been introduced in recent years, and biosimilars of monoclonal antibody and fusion protein therapies are now emerging. However, the situation in this region is complicated by the presence of “non-comparable biotherapeutics” (also known as “intended copies”), which have not been rigorously compared with the originator product. We review the considerations for clinicians in Latin American countries, focusing on monoclonal antibody biosimilars relevant to oncology, rheumatology, gastroenterology, and dermatology.

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Section: Biosimilars In Latin America: Current Situationmentioning

confidence: 99%

Section: Biosimilars In Latin America: Current Situationmentioning

confidence: 99%

“…46–48 In general, the region is moving toward increasing standards of regulation, and the WHO guidelines have been adopted or used as a basis for guidance in several instances. 45,50 …”

Section: Biosimilars In Latin America: Current Situationmentioning

confidence: 99%

Section: Biosimilars In Latin America: Current Situationmentioning

confidence: 99%

Section: Biosimilars In Latin America: Current Situationmentioning

confidence: 99%

See 3 more Smart Citations

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

Scheinberg

Pineda

Castañeda‐Hernández

et al. 2018

mAbs

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Barriers towards effective pharmacovigilance systems of biosimilars in rheumatology: A Latin American survey

Castañeda‐Hernández

Sandoval

Coindreau

et al. 2019

Pharmacoepidemiology and Drug

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Purpose This review summarises the current status of regulatory guidelines for the approval of biosimilars in Latin America and highlights the main barriers to effective pharmacovigilance in this region. We also report results from a survey of Latin American rheumatologists assessing their understanding of prescribing biosimilars and the pharmacovigilance of these drugs. Methods We reviewed the current guidelines for the regulatory approval of biosimilars and barriers to effective pharmacovigilance in Latin American countries. Rheumatologists attending the II Pan‐American League of Rheumatology Associations PANLAR Review Course (Biosimilars update) in Lima, Peru were asked to complete a short survey to determine their knowledge of biosimilars. Results Many Latin American countries continue to lag behind Europe and the United States in establishing regulatory guidance and effective pharmacovigilance systems for biosimilars. Results from our survey also highlight a lack of awareness regarding the availability of biosimilars, their nomenclature, automatic substitution, and reporting adverse drug reactions because of these drugs. Conclusions The main barriers to effective pharmacovigilance in Latin America are the lack of consensus on the interchangeability of reference biologics and biosimilars, and the need for more suitably trained personnel to carry out effective postmarketing pharmacovigilance of biosimilars. Inconsistencies in biosimilar nomenclature make it difficult to adequately trace drugs and record adverse drug reactions associated with their use, creating a barrier to the global pharmacovigilance of biologics.

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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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Recommendations for the regulation of biosimilars and their implementation in Latin America

Cited by 29 publications

References 24 publications

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

Barriers towards effective pharmacovigilance systems of biosimilars in rheumatology: A Latin American survey

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

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