🧪Biosimilars Interchangeability

"A biosimilar is never going to be identical to its reference biological product - therefore biologics are not regulated as generics in the leading markets (EU and US). "

The foundation of #biosimilarity is the analytical similarity that identifies the differences between a potential #biosimilar and its reference product. Thus, the visible impact of any differences must generally be assessed at the clinic to determine if the differences matter.

The world that turned "upsidedown"

Each biosimilar developer may follow a different development program depending on product characteristics and manufacturing processes.

Not all biosimilars are interchangeable because in order to get this distinction they must meet highly strict standards provided by the FDA that, among other things, require several additional #interchangeability studies. These studies are designed to show that there is no increased risk of safety or loss of efficacy when patients are switched back and forth multiple times from the reference product to the Interchangeable biosimilar. 

How is an Interchangeability study conducted?

Interchangeability designation enables auto-substitution at the pharmacy level. The interchangeable product will have the same clinical result as the reference product.

Prescribers and their patients can be assured that an FDA-approved interchangeable product has been thoroughly tested and has met FDA’s high standards for approval.

Meeting these standards means that health care professionals and patients can be assured of the safety and effectiveness of an interchangeable product, just as they would be for a reference product.

Key takeaways:

• A biosimilar is never going to be identical to its reference biological product therefore biologics are not regulated as generics in the leading markets (EU and US).
• The foundation of biosimilarity is the analytical similarity that identifies possible differences between a potential biosimilar and its reference product.
• The impact of any differences must be generally assessed in the clinic to determine whether the differences matter or not.
• Each biosimilar developer may follow a different development program depending on product characteristics and manufacturing processes.

Information gathered from the recent event - Biosimilars LatAm - Brazil 2022 | Panel: Biosimilar Interchangeability - Cinthya Galicia Quintanar (President - @AMFV | Country Manager - Pfizer Mexico)

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