Biosimilars: what clinicians should know

Weise, Martina; Bielsky, Marie-Christine; Smet, Karen De; Ehmann, Falk; Ekman, Niklas; Giezen, Thijs J.; Gravanis, Iordanis; Heim, Hans-Karl; Heinonen, Esa; Ho, Kowid; Moreau, Alexandre; Narayanan, Gopalan; Kruse, Nanna Aaby; Reichmann, Gabriele; Thorpe, Robin; Aerts, Leon van; Vleminckx, Camille; Wadhwa, Meenu; Schneider, Christian K.

doi:10.1182/blood-2012-04-425744

Cited by 321 publications

(286 citation statements)

References 26 publications

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“…29 Given that even small differences in the manufacturing process may affect the performance of a biologic, it has been agreed that the regulatory pathway for generic medicines, which is based on bioequivalence data alone, is not appropriate for biosimilars. Importantly, “biosimilarity” is a regulatory designation; it does not have a scientific definition.…”

Section: Biosimilarity: Overview Of Fundamental Principlesmentioning

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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Section: Biosimilarity: Overview Of Fundamental Principlesmentioning

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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show abstract

“…Reports of safety issues with some of these products, such as recombinant erythropoietins, have raised concerns about the quality of these biologics. [45][46][47][48] For example, increased rates of pure red-cell aplasia were observed in patients with chronic kidney disease who received subcutaneous administration of recombinant human erythropoietin compared with the reference product. Such adverse reaction appeared associated with an increased immunogenicity of the biologic product, with induction of anti-erythropoietin antibodies and pure red-cell aplasia in treated patients.…”

Section: International Nonproprietary Names and Naming Of Biosimilarsmentioning

confidence: 99%

Regulatory considerations in oncologic biosimilar drug development

Macdonald

Hartman

Jacobs

2015

mAbs

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“…Generic versions of small molecule drugs have well-defined structure, are relatively easily synthesized, and are exact copies of brand-name drugs and, therefore, bioequivalent and interchangeable. Biosimilars are biological products that are highly similar to reference product but have "allowable differences" due to the complex and variable chemical structures produced by living organisms [7]. It is quite difficult to produce a copy of a biological product that is identical in all respects.…”

Section: Introductionmentioning

confidence: 99%

A Primer on Biosimilars: FDA-Approved and those in the Pipeline

Pillai¹,

Malcom²,

Cox³

2017

SOJPPS

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Biologics have made groundbreaking treatments possible, for several difficult to treat conditions. However, they are very expensive, and biosimilars are expected to push prices down like the generics of small molecule drugs did in the past, replacing more costly brandname drugs. Biosimilars are not just generic replacement for brand name biologics, and their effect on cost reduction will be much more modest. Biologics, made from living organisms, are much larger in size and complex molecules than small molecule drugs which are easily synthesized, characterized and copied. Biosimilars may be highly similar to the original licensed biologic product but not a fingerprint copy; therefore, some differences are expected. This article describes the criteria for establishing similarity and interchangeability, current regulations and the clinical and pharmacoeconomic aspects of the four FDA approved biosimilars in 2015 and 2016.

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Biosimilars: what clinicians should know

Cited by 321 publications

References 26 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

Regulatory considerations in oncologic biosimilar drug development

A Primer on Biosimilars: FDA-Approved and those in the Pipeline

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