In this episode, we get further insight into the current state of biosimilars development and adoption in the United States vs other countries, interchangeability among adult and pediatric patients with rheumatologic conditions, nonmedical switching to biosimilars, and an overview of its potential cost benefits for the US healthcare system.
The Food and Drug Administration (FDA) has approved Abrilada (adalimumab-afzb; Pfizer), a biosimilar to Humira (adalimumab; AbbVie).
Effective for illnesses ranging from cancer to autoimmune diseases, biologics are among the most expensive prescription drugs in the United States.
The FDA has released an updated draft guidance that will update the naming convention of biologic medications.
Amgen has submitted a Biologics License Application (BLA) for ABP 710, a biosimilar to infliximab (Remicade).
The safety of switching from reference rituximab to the rituximab biosimilar was comparable to continuation of reference rituximab.
The FDA has released a Biosimilar Action Plan to promote competition and affordability across the market for biologic and biosimilar products.
Allan Gibofsky, MD, shares insight on the cost associated with nonmedical switching in patients with rheumatic diseases.
The FDA has withdrawn draft guidance intended to provide advice regarding the evaluation of analytical similarity between a biosimilar and a reference product.
FDA Commissioner, Scott Gottlieb MD, said, “The FDA shares the goal of ensuring that American patients have access to quality and affordable care that meets their needs.”