Complex, Investigatory Formats

As copies of therapeutic products that have been marketed for many years and used to treat thousands of patients, the antibodies under development as biosimilars are amongst the most comprehensively studied biologic therapeutics. A quick literature search will reveal descriptions of multiple mechansims of action (MMOA) of each of these molecules, many of which can be directly associated with potency of the drug, some that may present some influence within a subset of indications and others that that may be characterised in vitro, but are unlikely to mediate a clinically meaningful activity.

Beyond those that can be classified as critical quality attributes, biosimilar developers are challenged to first determine which of these additional MMOAs warrants characterisation, secondly, what type of assay format should be applied and how the data should be analysed and finally, the scope of individual assessments. Once comparative data becomes available between the biosimilar and the reference medicinal product, product-specific investigatory formats may be required to determine impact of differences on clinical efficacy and safety.

With a comprehensive understanding of the MOAs of the biosimilar antibodies coupled with world class approaches for in vitro characterisation of biosimilars, we are well placed to both assist you in defining appropriate investigatory approaches and perform the necessary testing. Our internal developmental focus is a range of investigatory bioassays for the anti-TNF-α biosimilar antibodies that focus upon secondary and tertiary activities of these molecules and we are happy to discuss other molecules.

To discuss requirements for your molecules or the investigatory formats we are working on, please click here to contact us