Biopharmaceuticals and biosimilars in psoriasis: What the dermatologist needs to know

• Published in: Journal of the American Academy of Dermatology Vol. 66; no. 2; pp. 317 - 322
• Main Authors: Strober, Bruce E., MD, PhD, Armour, Katherine, MD, Romiti, Ricardo, MD, Smith, Catherine, MD, Tebbey, Paul W., PhD, Menter, Alan, MD, Leonardi, Craig, MD
• Format: Journal Article
• Language: English
• Published: United States Mosby, Inc 01.02.2012
• Subjects: Antibodies, Monoclonal - pharmacokinetics; bioequivalence; Biological Products - therapeutic use; biologics; biopharmaceuticals; Biosimilar Pharmaceuticals - economics; Biosimilar Pharmaceuticals - standards; Biosimilar Pharmaceuticals - therapeutic use; biosimilars; Clinical Trials as Topic; Dermatology; Drug Approval; Drugs, Generic - standards; Epoetin Alfa; Erythropoietin - chemical synthesis; Erythropoietin - standards; follow-on biologics; generics; Humans; Interferon beta-1a; Interferon-beta - chemical synthesis; Interferon-beta - standards; Pharmacokinetics; psoriasis; Psoriasis - drug therapy; Recombinant Proteins - chemical synthesis; Recombinant Proteins - standards; Therapeutic Equivalency; FDA; biologics; EPO; biopharmaceuticals; TNF; generics; tumor necrosis factor; follow-on biologics; psoriasis; biosimilars; pharmacokinetics; EMA; European Medicines Agency; bioequivalence; Food and Drug Administration; erythropoietin
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/j.jaad.2011.08.034

The entry of biosimilar forms of biopharmaceutical therapies for the treatment of psoriasis and other immune-mediated disorders has provoked considerable interest. Although dermatologists are accustomed to the use of a wide range of generic topical agents, recognition of key differences between original agent (ie, the name brand) and the generic or biosimilar agent is necessary to support optimal therapy management and patient care. In this review we have summarized the current state of the art related to the impending introduction of biosimilars into dermatology. Biosimilars represent important interventions that are less expensive and hence offer the potential to deliver benefit to large numbers of patients who may not currently be able to access these therapies. But the development of biosimilars is not equivalent to that of small molecule generic therapies because of differences in molecular structure and processes of manufacture. The planned regulatory guidelines and path to approval may not encompass all of these potentially important differences and this may have clinical relevance to the prescriber and patient. Consequently, we have identified a series of key issues that should be considered to support the full potential of biosimilars for the treatment of psoriasis; ie, that of increased access to appropriate therapy for the psoriasis population worldwide.