Biosimilars in psoriasis: the future or not?
As patents for the biologic agents reach their expiration dates, dermatologists must prepare for the coming of biosimilars. These agents have been deemed "highly similar" to their reference products in a process outlined by the US Food and Drug Administration (FDA). In 2016, the FDA approved 3 biosimilars for various indications including plaque psoriasis and psoriatic arthritis. However, biosimilars are not the same as small-molecule generics because they have a complex manufacturing process that makes it impossible to produce identical products to their reference products. Therefore, should biosimilars be granted FDA approval for the same indications as their reference products? Furthermore, can biosimilars automatically be substituted for the branded drug at the pharmacy level? Putting aside these technical concerns, physicians must focus on the impact of biosimilars on patient care. These agents will have to be integrated into a complex health care system comprised of drug developers, employers, payers, and drug formularies.
Weill Cornell Medical College, New York, New York, USA.
Roselyn
R
Kellen
Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Gary
G
Goldenberg
D000328:Adult; D015535:Arthritis, Psoriatic / Q000188:drug therapy*; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D017277:Drug Approval / Q000331:legislation & jurisprudence; D006801:Humans; D010330:Patents as Topic; D011565:Psoriasis / Q000188:drug therapy*; D014481:United States; D014486:United States Food and Drug Administration
D059451:Biosimilar Pharmaceuticals; D003879:Dermatologic Agents