Biosimilars Video Resource Summary
Biosimilar Manufacturing
This is an educational biosimilars resource provided by Organon.
Transcript:
Over the lifecycle of a biologic, numerous manufacturing changes are instituted. Due to the complexity of these products, each change must meet FDA requirements to ensure product quality for each batch.
Comparing quality means the quality attributes of the post-change batch are highly similar to the pre-change batch. A determination of comparability can be based on analytical testing, biological assays, and, in some cases, clinical and nonclinical data.
The biosimilar must show no clinically meaningful differences in safety, purity, and potency to the reference biologic through a multifaceted approach.
The biosimilar must show no clinically meaningful differences in safety, purity, and potency to the reference biologic through a multifaceted approach, which begins with analyzing batches of the reference biologic for its critical quality attributes (CQAs).
These are used to develop a biosimilar that is highly similar to the reference biologic. Like the reference biologic, the biosimilar must also compare against the CQAs from the reference biologic batches.
Manufactured to be highly similar to the reference biologic
Analytical structural testing and functional and clinical testing are used to validate that the biosimilars and reference biologics have no clinically meaningful differences in terms of safety, purity, and potency.
Once a biosimilar is approved by the FDA, each additional batch must continue to be tested to ensure the product quality meets the rigorous standards set forth by the FDA.
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.
