Over the last decade — since biosimilar sponsors tackled the first wave of innovator biologics coming off patent — biosimilar drug development has become increasingly crowded and complex. Biosimilar sponsor strategies now include novel R&D approaches to combat ever-changing innovator tactics. For example, sponsors of newer biosimilars may change the formulation of the biosimilar when compared with the reference product, such as the use of subcutaneous (SQ) vs. intravenous (IV) administration for biosimilars of trastuzumab.
With the growing biosimilars competition, there is a need to develop novel trial designs to shorten biosimilar drug development timelines and gain cost-effectiveness. Our Bayesian technique approach provides a strategy for borrowing information from the reference product from published pivotal trials of the reference product.