In the Special Content Considerations section of the AMCP Format for Formulary Dossiers, the fourth topic is Biosimilars. With the interest in biosimilars, health care decision makers need to know if there is data to prove that biosimilars are as effective as their innovator/reference drug. The AMCP Format encourages biosimilars to create dossiers that provide the same level of evidence data as innovator/reference drugs and which delineate between direct and extrapolated evidence.
Check back for more information on changes in the new AMCP Format for Formulary Submissions. If you need any assistance with your dossier (or other documents) for a biosimilar product, let us know: 877-477-0977 or https://medcommunications.com/contact-us/