The development of

biosimilars

A rigorous process

The process for biosimilar medicine development involves rigorous analytical studies to establish a comprehensive understanding of the similarity of the biosimilar to the reference product. Assessments of toxicity and clinical studies are also used to further establish similarity. Ultimately, the goal is to demonstrate that there are no clinically meaningful differences between the reference product and the biosimilar based on the findings from all of these studies.

Building on the established clinical profile of the reference biologic.

Using multiple state-of-the-art-methods, protein structures can be extensively characterized so that the reference product and biosimilar can be directly compared, helping to ensure comparability of both functional integrity and performance in vivo. These comparisons, with respect to the structure and function of the molecule, will provide the foundation for development, which builds on the clinical experience with the reference product.

Biosimilar development requires substantial time and financial investment

Development of biosimilar medicines begins with substantial investment in the specialized infrastructure, expertise, and technology required to create the product, verify that it is biosimilar, and ultimately to maintain quality production.

While biosimilars have the potential to provide additional treatment options at lower cost, development of biosimilars requires significant investment. Development of a biosimilar may take 5 to 9 years at a cost of over $100 million, not including regulatory fees. A generic version of a small-molecule drug, on the other hand, costs $1 million to $2 million and takes approximately 2 years to develop.

Drug development comparison

*Not including regulatory fees.

The development processes for biologics and biosimilars are considerably more rigorous than the development process for small-molecule generics.

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