Optimizing Biological and Biosimilar Therapies in the Modern Era is organized by Healthcare Made Practical (HMP) Communications LLC and will be held from Dec 21, 2018 - Dec 21, 2019.
Imedex designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit™.
Physicians should claim only the credit commensurate with the extent of their participation in the activity.
NACCME has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with the AAPA CME Criteria. This activity is designated for 1.0 AAPA Category 1 credit(s).
PAs should only claim credit commensurate with the extent of their participation.
This continuing nursing education activity awards 1.0 contact hour.
Provider approved by the California Board of Registered Nursing, Provider #13255 for 1.0 contact hour.
This knowledge-based activity (JA0006201-9999-18-243-H01-P) is approved for 1.0 contact hours (0.01 CEUs) of continuing pharmacy education.
This activity is intended for IBD specialists, gastroenterologists, GI fellows, and other healthcare professionals (internists, primary care physicians, nurse practitioners, physician assistants, nurses, pharmacists, etc) involved and/or interested in the therapeutic management of patients with IBD.
Biosimilars, biological products that are nearly identical to a reference medicinal product in terms of safety, purity, and potency, have been approved in the European Union since 2006, and 5 biosimilar products have been approved by the FDA for use in patients with inflammatory bowel disease (IBD) to date. With many more biosimilar versions of biologics used for the management of IBD on the horizon, clinicians are challenged to evaluate the both the rationale for biosimilar use and the potential safety and efficacy considerations related to their use in clinical practice.
This webcast aims to provide expert guidance to help clinicians interpret the issues surrounding the use of biosimilars and prepare them to evaluate clinical data regarding biosimilars in patients with IBD.
Upon successful completion of this educational activity, participants should be better able to:
• Describe the regulatory requirements for biosimilars approval such as the clinical data package, totality of evidence, extrapolation of data, interchangeability, and substitution
• Evaluate recently approved and late-stage anti-TNF biosimilars and their respective safety, efficacy, biosimilarity, and switching data
• Incorporate biosimilars for the treatment of IBD into individualized treatment plans
• Initiate strategies to educate and inform patients about biosimilar benefits, limitations, core concepts, and impact on accessibility