Biosimilar Development

Biosimilar products are biological products that are made to look like brand-name biologics that have already been approved by the FDA through the BLA process. There are no clinically important differences between the reference products and the biosimilar products. A biosimilar product works as well as a generic product and is just as safe.

When it comes to developing and making biologics, the process is the product. As technology has improved, this has made it possible to make new biologics just as precisely as brand name products.

But making medicines that are biosimilar requires skilled, unique, and careful steps. It also requires a number of thorough development and analysis studies, as well as a full understanding of how biosimilar and brand-name products are alike.

At Synergy Bioscience, we use cutting-edge technology and infrastructure to show similarities. We have some of the best scientists in the business working for us.

To compare the biosimilar with the brand-name product, we do a series of detailed analyses of how they work and how they are put together. This helps us keep high-quality production going.

We make it easier to start a biosimilar program by doing specific tests, such as clinical trials of dissimilarity, extrapolation, pharmacokinetic, and toxicology testing/evaluation.

When we make our biosimilar molecules, we test how similar they are to the brand drug from a biological and non-clinical point of view. To make sure the drug is safe, we test it for toxicology and/or pharmacokinetics.

Extrapolation is a scientific and legal rule that focuses on making it easier to make a biosimilar product. It cuts down on studies that aren’t needed and moves valuable resources to better uses when making biosimilar medicines. This method is also part of the complex steps we take to keep quality high, and it helps our partners.

At Synergy Bioscience, the meticulous gradual approaches we employ are as follows:


    • Comprehensive analytical testing that includes a relatively structural and functional depiction and a high similarity to the brand drug
    • Comparison of all therapeutic functions predicted with the reference product (Head-to-Head comparison)
    • Carrying out pharmacokinetics and pharmacodynamic
    • Evaluation of toxicology
    • Evaluation of dissimilar monoclonal antibodies
    • Examinations of the primary structure, product variants, Fc-Medicated binding, and Fab-medicated binding of the products
    • Size exclusion high-performance liquid chromatography (SE-HPLC)
    • Adopting the concept of extrapolation
    • Stability indicating assay for the easy identification of impurities
    • Development of products under the coverage of “totality of the evidence”.
    • Clinical testing, approval, and information on the purity, safety, and efficacy of the final product.
    • Case-by-case approach for each product and adherence to the regulatory pathway.

We put the safety and effectiveness of the products at the top of our list, and we take the right steps to keep the biological activity of the products. Among these steps is an analysis of our planned products’ physicochemical and functional properties to see if they are biosimilar to the brand product.

Our goal is to keep development and testing services affordable while making sure they are of the highest quality. We follow the rules set by the government and make sure that the medicines are immunogenic, safe, and effective.

This ultimate development program is made to speed up your development work and save you money.

We’re here to help. LET US GET STARTED!

To discuss how Synergy Bioscience can help you, please contact us