In the fifth episode of the GHAPP & RhAPP biosimilar podcast series host Amanda Mixon, PA-C, and guest Betsy Kirchner, DNP review the important concept of biosimilar extrapolation.

The learning objectives for this episode are to:

• Define extrapolation
• Understand why extrapolation is important.
• Understand the key aspects that may be considered for scientific justification of extrapolation including:
         -MOA in each condition
         -Pharmacokinetics and biodistribution
         -Expected toxicities
         -Other- concomitant medications/comorbidities

Please take our evaluation regarding this podcast here: https://www.ghapp.org/biosimilars-podcast-eval

In the fourth episode of the GHAPP & RhAPP biosimilar podcast series host Gabriella McCarty, NP  and guest Tedra Gray, NP discuss the differences between biosimilars and generic drugs.

The learning objectives and goals for this episode are to:
-Compare and contrast biosimilars and generics regarding:
         -Molecular size and structure
         -Complexity of development
         -Cost of development

Please take our evaluation regarding this podcast here: https://www.ghapp.org/biosimilars-podcast-eval

Welcome to our third episode of the GHAPP & RhAPP biosimilar podcast series! In this episode host Amanda Mixon, PA-C has an in-depth conversation with the incredible Danielle Gatti-Palumbo, PharmD, BCACP, AAHIVP,  about The Regulatory Pathway to Biosimilar Approval.

The learning objectives and goals for this episode are to:
-Summarize the totality of evidence approach to determining biosimilarity including:
      -Analytical testing for comparative structural and functional characterization
      -Nonclinical testing to evaluate the safety profile
      -Comparative human pharmacokinetic and pharmacodynamic studies
      -Immunogenicity Assessment
      -Comparative clinical studies if needed

Please take our evaluation regarding this podcast here:  https://www.ghapp.org/biosimilars-podcast-eval

Join us for our second episode of the GHAPP & RhAPP biosimilar podcast series! In this episode host Amanda Mixon, PA-C discusses the Development of Biosimilars with our esteemed guest Tanya Golovanoff, PharmD.

The learning objectives and goals for this episode are to:
-Distill the immense amount of research and development that occurs to develop biosimilars
-Articulate the biosimilar manufacturing process
-Explain how biosimilars are named

Please take our evaluation regarding this podcast here: https://www.ghapp.org/biosimilars-podcast-eval

Join us for the first episode of the GHAPP & RhAPP biosimilar podcast series! In this episode Gabriella McCarty, NP-C and Jennifer Geremia, PA-C discuss What Are Biosimilars?

The learning objectives and goals for this episode are to:
-Define biologic therapy
-Define biosimilars
-Define reference product
-Summarize the impact of The Biologics Price Competition and Innovation Act

Please take our evaluation regarding this podcast here: https://www.ghapp.org/biosimilars-podcast-eval