Products that are proven to be highly similar to previously licensed biological medicines are referred to as “biosimilars”. A legal and regulatory framework has been implemented in Europe to create an abbreviated registration process for biosimilars. This has enabled the approval of several products that provide patients and healthcare authorities with more cost-effective options for proven safe and effective therapies. These benefits are also now realised throughout the world, with adoption of similar guidelines by many authorities outside of Europe including Japan, Australia and many emerging markets. Recent legislation in the United States should result in a regulatory pathway for FDA approval of these economically important healthcare products in the near future.
While approvals of generic versions of small molecule drugs are now considered relatively routine, biosimilars are far more complex. Regulatory agencies have recognized that generation of absolutely identical versions of previously licensed biological products is not essential in order to achieve the same biological efficacy and safety. Proving the absence of a significant difference between a biosimilar and its comparator product requires the assembly of an extensive body of data demonstrating their similarity. In addition to the completion of confirmatory non-clinical and clinical studies, the availability of advanced analytical methods allows us to characterize biosimilars sufficiently to demonstrate the required level of similarity.
This concept of designing cell lines and manufacturing processes to create biosimilars to a specific product profile is a natural extension of Eden Biodesign’s “begin with the end in mind” approach to development. Through its extensive consultancy and “hands on” experience, coupled with Watson Pharmaceuticals’ clinical, legal and commercial expertise, Eden Biodesign has the technical, manufacturing, regulatory and strategic capabilities required to successfully develop biosimilars for global approval.