Biosimilars and Interchangeable Biologics

Even very established companies have made mistakes when developing biosimilar products. For example, not appreciating future threats to intellectual property caused a biosimilar product development plan to fail after millions have been spent. Additional pitfalls include not anticipating the next line of improved products, better formulations, delivery systems and the possibility that the dosing and indications can themselves be patented. This two-volume set examines how to choose the right product to develop and how to meander around the legal fireworks and secure a viable commercial presence.