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.