1 Learning Objectives • Compare and contrast biosimilars to their reference product and generic therapies in terms of structure, manufacturing, regulatory pathway, and clinical properties • Evaluate evolving policy related to prescribing, dispensing, and maintaining pharmacovigilance with biosimilars • Determine whether biosimilars are appropriate for select patients with RA based on their benefits/limitations, disease- and treatment-related factors, and patient preferences
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Multidisciplinary Perspectives on the Emerging Biosimilars ...FDA = Food and Drug Administration FSH = follicle-stimulating hormone HgH = human growth hormone JIA = juvenile idiopathic
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Learning Objectives
• Compare and contrast biosimilars to their reference product
and generic therapies in terms of structure, manufacturing,
regulatory pathway, and clinical properties
• Evaluate evolving policy related to prescribing, dispensing, and
maintaining pharmacovigilance with biosimilars
• Determine whether biosimilars are appropriate for select
patients with RA based on their benefits/limitations, disease-
and treatment-related factors, and patient preferences
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What Is a Biosimilar?
• A biosimilar is a product that is highly similar to an FDA-approved
biopharmaceutical (ie, “reference product” or “biooriginator”) that will
be out of patent in 10 years and has:
– Undergone rigorous analytical and clinical assessment, in
comparison to its reference product
– Been approved by a regulatory agency according to a specific
pathway for biosimilar evaluation
• A biosimilar is highly similar to its reference product in
physicochemical characteristics, purity, potency, efficacy, and safety
www.fda.gov/Drugs/DevelopmentApprovalProcess/; Beck A, et al. Anal Chem. 2012;84:4637-46;
Dörner T, et al. Nat Rev Rheumatol. 2015;11:713-24.
Biosimilars Are Not…Second-Generation (or “Biobetter”)
Overview of the Regulatory Pathway and FDA’s Guidance for the Development and Approval of Biosimilar Products in the US.
www.fda.gov/downloads/AdvisoryCommittees/Committees MeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM486171.pdf. Accessed September 7, 2016.
Overview of the Regulatory Pathway and FDA’s Guidance for the Development and Approval of Biosimilar Products in the US. http://www.fda.gov/downloads/AdvisoryCommittees/Committees MeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM486171.pdf. Accessed September 7, 2016.
“Stand-Alone”
Development Program, 351(a)
Goal: To establish safety and
efficacy of a new product
“Abbreviated”
Development Program, 351(k)
Goal: To demonstrate biosimilarity
(or interchangeability)
Analytical
Non-clinical
Clinical Pharmacology
Clinical
Safety and Efficacy
(Phases 1, 2, 3)Clinical
Pharmacology
Non-clinical
Analytical
Additional
Clinical Studies
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FDA Proposed Guidance on Naming
• USAN with an added random four-letter suffix, devoid of meaning,
for all biologics (including reference products) with limited
exceptions
• Filgrastim in the US (approved indications vary)
– Filgrastim (reference biologic)
– Tbo-filgrastim (not biosimilar [351(a)])
– Filgrastim-sndz (biosimilar [351(k)]
• Benefits
– Ability to differentiate products for pharmacovigilance purposes
– Common core names will group similar biologics in electronic
systems
– Having suffix for all products reduces perception that biosimilar is
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attestation, and post-test.
Unless otherwise indicated, photographed subjects who appear within the content of this activity or on artwork associated with this activity are models; they are not actual patients