What is the best way to approach biosimilar development?

27th March 2017

Category: Bioanalytical / Biosimilars

Tags: , , ,

By: Dr Terry Gray, Field Marketing Manager,

Part one

Monoclonal antibodies have a highly specific targeted action which allows a reduction in side effects compared to small molecule drugs, which has seen them becoming a mainstay of modern medicine. The innate complexity of these molecules allows them to be potent drugs that activate molecular cascades within the immune system.

So what does this mean?

It allows the targeting of diseases which were once thought to be impossible to treat, such as cancer or autoimmune dysfunction. However, as a result of the complexities of manufacture, these therapies regularly come with a high price tag and are unaffordable to many patients across the globe.

Why is this?

If you look at small molecule-type drugs in comparison, the process of chemical synthesis can guarantee that each batch of active ingredient is identical.  But with antibody-based therapeutics, the living cells employed as factories for production result in an intrinsic level of variability, despite the strongest efforts to control and optimize manufacturing.

What are the best practices for biosimilar development?

To demonstrate biosimilarity it is essential that the biological product has been proven to be highly similar to the originator product and has no clinically meaningful differences in terms of its safety and efficacy. An abbreviated licensure pathway for products which are able to demonstrate this has been outlined by the EMA, FDA & WHO. For biosimilar drugs, the foundation for approval is built on a robust analytical data package that demonstrates the similarities between the reference product and the biosimilar molecule, as outlined in the above figure. With that being said, this will always require the provision of a preclinical PK/PD study together with a focused clinical trial. The greater the scope of these studies, the greater the cost of a biosimilar development program.

What methods can be used to offset this?

The extent of the in vivo and clinical studies required can be offset against a robust analytical package. The aim here would be to justify that the established safety and efficacy data for the reference product also applies to the biosimilar, as a highly similar package assumes a lower risk of clinical differences. This package should incorporate both the physicochemical and biological characteristics of the biosimilar in comparison to its reference originator biologic.

What are the benefits of such a package?

By interpreting the physicochemical components alongside the biological data, the strength of the analytical package is increased, reducing the risk of unforeseen and critical consequences. This “totality of evidence” approach is imperative in demonstrating a high level of similarity to the reference molecule at an early stage.

Continue to Part 2

To find out more about an orthogonal approach to biosimilar development, download our white paper.

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