Development
Sandoz has been developing biosimilars since 1996, and also enjoys extensive synergies with other Novartis divisions including modeling and simulation support for clinical trials, therapeutic area expertise (particularly in oncology), and shared analytical platforms.
Effective biosimilar development involves managing opposing needs: speed to market on the one hand, and cost-effectiveness on the other. At Sandoz, we see this as a two-step process: first, guaranteeing a high level of molecular similarity to the reference product, then driving commercial viability through appropriate clinical tests to ensure a broad clinical label.
At the heart of our approach is a concept known as Quality by Design: ensuring quality by designing manufacturing processes that ensure comparability with the original product. In other words, the product does not need to “be” the process – it is end quality that counts. This approach has been tried, tested, and proved to work in practice.
