title: Regulatory considerations in oncologic biosimilar drug development.
abstract: Biosimilar monoclonal antibodies are being developed globally for patients with different types of solid tumors and hematologic malignancies. Applications for proposed biosimilar monoclonal antibodies are being submitted to the regulatory authorities around the world and may increase patient access to key treatment options upon approval. An understanding among stakeholders (e.g., physicians, patients and their caregivers, pharmacists, payers) of the approval criteria, as well as the similarities and differences in regulatory pathways involved in biosimilar approval in different countries, as presented in this review, will facilitate identification of high-quality, safe, monoclonal antibodies that have been developed according to strict, biosimilar regulatory standards. Further guidance and resolution of the ongoing discussions on biosimilar labeling, naming, automatic substitution, and indication extrapolation may ensure, in the future, an effective and appropriate use of biosimilar monoclonal antibodies by oncologists and other stakeholders in daily clinical practice.
authors.affiliation: a Pfizer Ltd. ; Tadworth , Surrey , UK.
authors.forename: Judith C
authors.initials: JC
authors.lastname: Macdonald
authors.forename: Helen
authors.initials: H
authors.lastname: Hartman
authors.forename: Ira A
authors.initials: IA
authors.lastname: Jacobs
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000912:Antibodies, Neoplasm / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals; D017277:Drug Approval; D006801:Humans; D007880:Legislation, Drug
chemical_list: D000911:Antibodies, Monoclonal; D000912:Antibodies, Neoplasm; D000970:Antineoplastic Agents; D059451:Biosimilar Pharmaceuticals
keywords: ADR, adverse drug reaction; ASBM, Alliance for Safe Biologic Medicines; CBER, US Center for Biologics Evaluation and Research; CDER, US Center for Drug Evaluation and Research; EBE, European Biopharmaceutical Enterprises; EMA, European Medicines Agency; EPAR, European Public Assessment Report; FDA, US Food and Drug Administration; INN, International Non-proprietary Name; SEB, subsequent entry biologic; SmpC, Summary of Product Characteristics; WHO, World Health Organization; biologics; biosimilars; interchangeability; labeling; mAbs, monoclonal antibodies; naming; regulatory