The biosimilars market has always been of great interest. However, since 2019 this interest has increased even more, due to the published FDA guidance on demonstrating biosimilar interchangeability. And just like that, the quest for interchangeability began!

Despite the need to provide additional information or data to demonstrate interchangeability, this is a much sought-after attribute for biosimilar developers, as it can mean a great competitive advantage. Why? Keep reading to know!

Why should you aim for interchangeability?

A biological product is manufactured from a living organism and, because of that, may contain variations within lots. The cause of these variations can be, for example, normal fluctuations in the natural process of protein production of the cell.

Therefore, the biologic reference product cannot easily be substituted by a biosimilar, due to this variable nature of biologics. Unless you can also demonstrate interchangeability!

According to the FDA, “an interchangeable biosimilar product may be substituted without the intervention of the healthcare professional who prescribed the reference product, much like how generic drugs are routinely substituted for brand name drugs.”

The FDA framework is based around a stepwise approach to gather evidence that a proposed biosimilar will have the same quality, safety and efficacy as its respective reference medicine.

And so, the interchangeability approval is particularly important for biosimilars, such as insulins, dispensed by pharmacists.

Additionally, the interchangeability status can add reassurance for patients and healthcare professionals that product effectiveness is identical, since there are additional studies and the data shows that the two medicines are comparable. This is relevant because lack of familiarity and trust in biosimilars is one of the reasons why healthcare professionals and patients still have a strong preference for the reference product, accepting the typical additional cost associated with the reference product.

Now that is clear why you should apply for interchangeability, it’s time to check how you do so!

How to conquer interchangeability

According to the FDA, to qualify for interchangeability the biosimilar must produce the same clinical result as the reference product. The data and information needed to meet this requirement can vary depending on the nature of the product. However, it may include:

  • Identification and analysis of critical quality attributes
  • Identification of analytical differences and how these differences may potentially impact clinical and patient response
  • An analysis of the mechanism of action in each condition of use
  • Analysis of differences in expected pharmacokinetics and biodistribution in different patient populations
  • An analysis of differences in expected immunogenicity risk and toxicity
  • Information on factors that could affect safety or efficacy

In addition, for products administered more than once, you need to prove that there is no added safety and efficacy risk associated with switching between the biosimilar and reference product.

It’s easy now to understand how applying for interchangeability adds even more complexity to the biosimilar approval process. As the amount of data, information and studies needed increases, you can definitely benefit from a multi-parametric and multivariate approach for your comparability and biosimilarity assessments.

The answer to easily approve your interchangeable biosimilars!

The approval process of your interchangeable biosimilars does not have to be a struggle! We can help you in your comparability studies with our multi-parametric and multivariate approach that is aligned with FDA’s totality-of-evidence framework.

Additionally, you can benefit greatly from our iSEE Platform™, a robust Data-Science solution and risk-based platform with a comparability module especially designed for biosimilars!

If you want to know more, we welcome you to check out our iSEE Platform™! And if you’d like to discuss how we can support you, feel free to contact us.

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