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

Gilberto Castañeda-Hernández, Zoltan Szekanecz, Eduardo Mysler, Valderilio F. Azevedo, Renato Guzman, Miguel Gutierrez, Wilfredo Rodríguez, Dmitry Karateev

Research output: Contribution to journalShort survey

35 Citations (Scopus)

Abstract

A biosimilar is a biopharmaceutical product intended to be comparable to a previously licensed biopharmaceutical agent. The goal of such products is to increase the accessibility of biopharmaceutical therapy for rheumatoid arthritis by reducing costs. They are not like generic drugs, in that they may differ from the reference products in manufacturing, composition, and formulation. Regulatory authorities strive to ensure the absence of clinically meaningful differences between biosimilars and their reference drugs. However, small molecular differences may potentially affect pharmacodynamics (including affinity), pharmacokinetics, and immunogenicity. Intended copies are non-innovator biopharmaceutical products that, unlike biosimilars, do not have enough clinical evidence to demonstrate biosimilarity. For approval of a biosimilar, most countries require preclinical and clinical studies demonstrating comparability with the reference drug. The margin for determining equivalence or non-inferiority is determined on a case-by-case basis in each country, as there are no general criteria. The European Medicines Agency and US Food and Drug Administration have stringent regulatory processes to ensure comparability of biosimilars with their reference drugs. There are also post-marketing surveillance requirements to monitor safety. Only one biosimilar, CT-P13, has been approved for rheumatoid arthritis. However, in countries with less stringent regulation, intended copies are being commercialized and safety problems have been documented. Consequently, in such countries, there is an urgent need for appropriate regulatory processes to be established. Attempts to close the affordability gap of biopharmaceuticals should not open another gap between patients treated with an innovator drug and an intended copy.

Original languageEnglish
Pages (from-to)471-477
Number of pages7
JournalJoint Bone Spine
Volume81
Issue number6
DOIs
Publication statusPublished - Jan 1 2014

Keywords

  • Biopharmaceuticals
  • Biosimilars
  • Innovators
  • Rheumatic diseases
  • Rheumatoid arthritis
  • Tumor necrosis factor (TNF) antagonists

ASJC Scopus subject areas

  • Rheumatology

Fingerprint Dive into the research topics of 'Biopharmaceuticals for rheumatic diseases in Latin America, Europe, Russia, and India: Innovators, biosimilars, and intended copies'. Together they form a unique fingerprint.

  • Cite this

    Castañeda-Hernández, G., Szekanecz, Z., Mysler, E., Azevedo, V. F., Guzman, R., Gutierrez, M., Rodríguez, W., & Karateev, D. (2014). Biopharmaceuticals for rheumatic diseases in Latin America, Europe, Russia, and India: Innovators, biosimilars, and intended copies. Joint Bone Spine, 81(6), 471-477. https://doi.org/10.1016/j.jbspin.2014.03.019