Biopharmaceuticals for rheumatic diseases in Latin America, Europe, Russia, and India: Innovators, biosimilars, and intended copies

Castañeda‐Hernández, Gilberto; Szekanecz, Zoltán; Mysler, Eduardo; Azevedo, Valderílio Feijó; Guzmán, Renato; Gutiérrez, Miguel; Rodríguez, Wilfredo; Karateev, D.

doi:10.1016/j.jbspin.2014.03.019

Cited by 46 publications

(40 citation statements)

References 31 publications

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“…Medicinal products that do not follow the appropriate procedures and yet receive approval due to less stringent regulations in certain countries, 29 for example, lack of a comparability exercise, otherwise known as non-comparable biologics, biomimics or intended copies of the originator, should not be used. Safety and efficacy standards are essential in biosimilars and should be respected by all entities manufacturing the product, all countries and their regulatory bodies approving the product, all physicians prescribing the product and all pharmacists dispensing the product.…”

Section: Resultsmentioning

confidence: 99%

Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers

et al. 2016

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Biosimilars present a necessary and timely opportunity for physicians, patients and healthcare systems. If suitably developed clinically, manufactured to the correct standards and used appropriately, they can positively impact on the financial sustainability of healthcare systems. A critical consideration regarding the introduction of biosimilars into the clinic centres on the required information concerning all the respective procedures. This position paper aims to describe the issues revolving around biosimilars that are relevant to the field of oncology, especially the prescribers. More specifically, we discuss aspects related to definition, forms of biosimilars, labelling, extrapolation, interchangeability, switching, automatic substitution, clinical standards on safety and efficacy, responsibilities among prescribers and pharmacists, potential impact on financial burden in healthcare and the current scenario and future prospects of biosimilars in Europe and the rest of the world.

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Section: Resultsmentioning

confidence: 99%

Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers

et al. 2016

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“…RDC n° 55/2010 does not specifies detailed requirements on PV and RMP: however, it refers to health legislation in effect (Anvisa, 2010). The Resolution does not address the question of interchangeability (Castaneda-Hernandez et al, 2014). …”

Section: Resultsmentioning

confidence: 99%

“…As indicated in regulations for biosimilars in Latin America, Europe and India, review article by Castaneda Hernandez, the Mexican regulations do not permit extrapolation between indications (Castaneda-Hernandez et al, 2014). …”

Section: Resultsmentioning

confidence: 99%

Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines

Rahalkar

Çetintaş²,

Salek

2018

Front. Pharmacol.

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Objective: The aim was to critically evaluate well-established regulatory agencies mAb biosimilar guidelines for development and marketing authorization about quality, efficacy and safety and compare to BRICS-TM regulations to identify challenges.Materials and Methods: The current valid guidelines of EMA, WHO, USFDA, BGTD/HC, ICH, and BRICS-TM were obtained from official websites and comparative qualitative review was performed.Results: The review revealed that Health Canada uses mAb specific guidelines from EMA or USFDA when necessary. The BRICS agencies (except Russia) have incorporated some or most of the WHO SBP TRS and related annexes in similar national biotechnological/biological guidelines; however, gaps or insufficient information have been identified. The Russian Federation has issued general product registration guideline/s with very brief information about mAbs. The TMMDA (Turkey) has published an updated biosimilar guideline which parallels those of the EMA and the ones from WHO; however, no mAb specific guidelines are published. COFEPRIS (Mexico) has published a biotechnological/biological product registration guideline with no information about mAb. The SAHPRA biosimilar guideline has an annex on mAbs which focuses on non-clinical and clinical aspects.The comparative evaluation of BRICS-TM agencies indicates a gap pertaining to clarification for physico-chemical characterization, manufacturing process, overages and compatibility requirements between biological substances and excipients specifically on mAbs. In vitro assay requirements seem quite aligned with those of WHO, whereas in vivo studies mostly have disparity in terms of necessity, type of studies as well as design and criteria. Clinical safety and efficacy studies are indicated in emerging regulatory agencies, however detailed information pertaining to design, size of populations, requirements for primary and secondary endpoints, clarity and evaluation criteria differ. In general, BRICS-TM agencies allow extrapolation of indications provided that pre-defined conditions are met. Interchangeability, switching and substitution of biosimilars are not defined in most of BRIC-TM guidelines whereas South Africa, by law, allows neither interchangeability nor substitution. Pediatric research remains questionable across BRICS-TM.Conclusions: EMA, USFDA guidelines are broadly aligned with WHO and in addition, they also contain specific requirements pertaining to their own region. BRICS-TM has considerably less defined mAb specific biosimilar development and comparability parameters in their published guidelines.

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“…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%

“…72 To the best of our knowledge, neither Bolivia nor Honduras has yet finalized an approval pathway specific to biosimilars. 46,50 The development program for BCD-020 encompassed comparative clinical studies in RA and lymphoma, from which data are available. 16,65,73 According to the manufacturer, multiple physicochemical and biological studies conducted in line with EMA guidelines have also been carried out, 72 although we are not aware that they have been published.…”

Section: Biosimilars In Latin America: Current Situationmentioning

confidence: 99%

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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Biopharmaceuticals for rheumatic diseases in Latin America, Europe, Russia, and India: Innovators, biosimilars, and intended copies

Cited by 46 publications

References 31 publications

Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers

Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers

Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines

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

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