Biosimilars Video Resource Summary
Transitioning to a Biosimilar
This is an educational biosimilars resource provided by Organon.
Transcript:
Hello, I’m Dr. Chris Fourment from Texas Digestive Disease Consultants and the GI alliance. I’m the co-founder and director of the department of clinical research and education.
Biosimilars are medicines approved by the Food and Drug Administration (FDA) as being highly similar to an already approved originator biologic.1 The method of administration and dosage of a biosimilar will generally be the same as the originator biologic.2
One potential misperception is that an FDA-approved, biosimilar product cannot be prescribed for patients currently treated with an originator biologic. A biosimilar can be prescribed for appropriate patients who have or have not been treated with the originator biologic.3
Another potential misperception is that interchangeability designation is required to switch a patient currently on an originator biologic to a biosimilar. Interchangeability designation is in fact not required for the transition from an originator biologic to a biosimilar.1
Key takeaways
When considering which patients may be appropriate for biosimilars it’s important to remember that:
- FDA-approved biosimilars may be appropriate for use in patients who have or have not been treated with the originator biologic.3
- Interchangeability designation is not required for transitioning to a biosimilar.1
Interchangeability designation is in fact not required for the transition from an originator biologic to a biosimilar.3
Additional Biosimilars Resources
FDA
FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards.
Biosimilars Forum
Providing evidence-based information to inform and support public policies that encourage awareness, access, and adoption of biosimilars.
