FOUR ESSENTIAL ELEMENTS OF OUR SCIENTIFIC PLATFORM ALLOW US TO ESTABLISH THAT OUR PRODUCTS WILL ACHIEVE BIOSIMILARITY, MEANING THEY WILL CLOSELY MATCH THE “ORIGINATOR” BIOLOGICS. THE PLATFORM EXTENDS FROM BIOANALYTICS AND PROCESS SCIENCE TO PATENT-BEARING INNOVATION IN MANUFACTURING AND FORMULATION.
Developing biosimilars requires tremendous up-front analytical work, as developers don’t have access to innovator information. This initial assessment is an onerous and complex process involving dozens of analytical methods. The assessment is at the core of determining biosimilarity. Diverse competencies are called into play, including the ability to evaluate the innovator’s sequence and glycosylation – among many other attributes.
Development of high-quality biosimilars requires meticulous molecular fine tuning and a thorough understanding of process science in order to develop a product that demonstrates in-vivo and in-vitro biosimilarity and PK (pharmacokinetic) bioequivalence. Without these skills, producing biosimilar molecular structures that ensure interchangeability is not possible.
Coherus has put in place a differentiated IP development strategy which focuses its collective scientific expertise and investment on the discovery of proprietary technologies that enable biosimilar innovation. For example, protein stabilization – the protein’s ability to maintain its structure and biological activity – is essential to obtaining a commercially viable biosimilar. We believe that discoveries of proprietary technologies like protein stabilization enable earlier market entry and speed biosimilars to patients in need.
To progress beyond this phase and win approval of regulators, companies must prioritize studies that will efficiently confirm the biosimilar matches the innovator in safety and efficacy.
Through skillful planning and disciplined management of critical development parameters – such as the selection, timing and cost of clinical trials – the Coherus team seeks to ensure successful drug development and manufacturing under very aggressive timelines.