Although the FDA does not have a hand in the regulation of drug prices, the safeguarding of access to medications is a crucial factor in the agency’s goal to foster and protect public health.
According to the ACR, a practical benefit of the guidance is that in situations where a biosimilar is not considered interchangeable, a pharmacist must ask the prescribing physician for a new prescription before switching a patient to or from a reference biologic.
Bellevue, WA—Although biologics have been a potent addition to the rheumatologist’s armamentarium, they come with complications, too, including high costs and regulatory confusion. In other words, their complexity extends far beyond the manufacturing process.
The American College of Rheumatology (ACR) has released an official position statement on biosimilars, on the heels of the first biosimilar approval by the US Food and Drug Administration (FDA). Filgrastim-sndz (Zarxio, Sandoz) was approved on March 6, 2015.
European physicians across 12 countries now have access to a more cost-effective treatment for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and other inflammatory conditions, with the approval of the first biosimilar monoclonal antibody for infliximab, CT-P13 (Remsima, Celltrion; Inflectra, Hospira), by the European Medicines Agency (EMA).
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