This week, James Stevenson, PharmD, FASHP, professor at the University of Michigan College of Pharmacy, delivered a webinar via the Academy of Managed Care Pharmacy.
This week, James Stevenson, PharmD, FASHP, professor at the University of Michigan College of Pharmacy, delivered a webinar via the Academy of Managed Care Pharmacy. The outset of the webinar focused on familiarizing pharmacists with key facts concerning biosimilars, including the following:
Dr Stevenson also discussed the role of clinical trials for biosimilars, explaining that:
Finally, the webinar addressed the issue of biosimilar interchangeability. Dr Stevenson stressed that the fact that no biosimilars have been deemed interchangeable to date does not indicate that these products are inferior to their references; instead, he said, because the FDA has not yet finalized its guidance on demonstrating interchangeability, there exists no path via which a biosimilar could achieve interchangeable status. He highlighted several important factors that will impact the eventual interchangeability of biosimilars, including the following:
Dr Stevenson said that recent reviews of the literature concerning anti-tumor necrosis factor (anti-TNF) biosimilars support the interchangeability of biosimilar products, and noted that many companies have included at least a single switching arm in their biosimilar trials, even in the absence of FDA guidance. Dr Stevenson's remarks echo those of FDA representatives who have suggested that biosimilars could begin to receive interchangeable designations within the next 2 years.