We know how to build up pharmaceutical development that cover every step along with the time and expenditures needed. We gained experience and knowledge through developing filgrastim biosimilar. With this know-how, we can make valid decisions in drug equivalency and consult with regulatory agencies in an effective manner.
We have many years of experience in the development of drug substance with the same properties as the original drugs. Our ability to work with numerous CMO/CRO in and outside Japan is another valuable strength. When developing a biosimilar, the key to success is the formulation of compounds with the same physical properties and same efficacy and toxicity as the original drug.
We have a large network of biologics and biosimilars including many experts in these fields. Our partnerships with CMO/CRO and biologics companies cover Japan, North America, Europe and Asia. This network demonstrates our ability to locate the best outsourcing firms and alliance partners for cell line development, production of drug substance, equivalency assessments for efficacy and toxicity, and other activities.
Our business model is structured for the development of biologics products for a broad spectrum of diseases. Our fabless operations allow us to select the most suitable CMO/CRO in Japan and overseas. Licensing out our drug substances and drug products allows us to form alliances with manufacturers in any field.