The Biosimilars Landscape: Strategies for Clinical and Commercial Success

The field of biosimilars is expanding rapidly. They provide an opportunity for cost savings for key stakeholders, and for pharmaceutical and biotech companies to control a share of the market as the patents for blockbuster biologic drugs expire. Biosimilars are a relatively new area of the market with challenges that require sufficient knowledge, experience and infrastructure to ensure smooth and successful progression through the development life cycle. This white paper discusses important considerations for embarking upon a biosimilars development program, including critical steps in their manufacturing, the current biosimilars regulatory environment and challenges in market access.