title: Frontiers in nonclinical drug development: biosimilars.
abstract: Biopharmaceuticals, produced by recombinant DNA technology, are generally more complicated to produce than small molecule drugs. As patents around the development and manufacturing of these biopharmaceuticals expire, biosimilars are being developed as comparable and more affordable alternatives to improve patient access and market competition. This commentary explains what a biosimilar is; it compares and contrasts biosimilar production with that of small molecule, generic, and other biological drugs; and it describes basic principles of the nonclinical development program for monoclonal antibody biosimilars.
authors.affiliation: Drug Safety Research and Development, Pfizer Inc., Groton, CT, USA anne.m.ryan@pfizer.com.
authors.forename: A M
authors.initials: AM
authors.lastname: Ryan
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; D017277:Drug Approval; D057915:Drug Substitution; D007880:Legislation, Drug; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals
keywords: biologics; biopharmaceuticals; biosimilar; drug development; monoclonal antibody; nonclinical; nonhuman primates; regulatory guidance