The Food and Drug Administration Friday issued final guidance clarifying how sponsors may show that a proposed biosimilar product is interchangeable with a brand name biological product. The guidance focuses on therapeutic protein products, one category of biological product. The Biologics Price Competition and Innovation Act of 2009 created an abbreviated licensure pathway for biosimilar products in an effort to increase competition for biological products and lower costs. Depending on state law, a biosimilar product that is interchangeable may be substituted for a brand name biological product at the pharmacy without the involvement of the prescriber, similar to how generic drugs are substituted for brand name drugs. Beginning next March under the BPCI Act, insulin products will be deemed biological products, meaning the guidance may also help biosimilar and interchangeable insulin products come to market.   
 

Related News Articles

Headline
The AHA, American Medical Association, American Society of Anesthesiologists, American Society of Health-System Pharmacists, and Association for Clinical…
Headline
Reps. Scott Peters, D-Calif., Eliot Engel, D-N.Y., Brett Guthrie, R-KY, Anna Eshoo, D-Calif., Richard Hudson, R-N.C., Michael McCaul, R-Texas, Kurt Schrader, D…
Headline
The Food and Drug Administration today released a proposed rule that would allow states and other non-federal government entities to establish programs to…
Headline
The Food and Drug Administration yesterday approved the first test to use next generation sequencing technology to detect HIV drug-resistance mutations in…
Headline
Pictured, from left to right: Peter Adamson, chair of the Children’s Oncology Group at the Children’s Hospital of Philadelphia; Brian Marden, chief…
Headline
The AHA, American Society of Anesthesiologists, American Society of Clinical Oncology, American Society of Health-System Pharmacists and Institute for Safe…