As a world leader in biosimilar testing, Creative BioMart provides various analytical assays for physic-chemical and biological properties, which can be applied to demonstrate comparability between production batches of a potentially similar biopharmaceuticals side-by-side with the originator.
The current guidelines for biosimilar allow a reduced drug development programme, making entry to the market much faster for biosimilar manufacturers. Although the pathway to licensure for biosimilar is reduced when compared to that of a new product, these cannot be considered identical to the innovator product and a number of assessments are required to demonstrate comparability. Comparability is defined as "a head-to-head comparison of a biosimilar product with a licensed originator product with the goal to establish similarity in quality, safety, and efficacy. Products should be compared in the same study using the same procedures".
Creative BioMart offers the experience and expertise to handle all of your testing requirements. Our biosimilar services provide a dedicated point of contact and include regulatory advice and consultancy to aid you through the process.
Request more information to see how Creative BioMart can help you with Comparability Studies for Biosimilars.
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