Biosimilars and Interchangeable Biologics ─ Tactical Elements
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商品簡介
Even the most established companies have made mistakes when developing biosimilar products. For example, not appreciating the 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, thus making the choice of products to develop a major exercise. This two-volume set examines how to choose the right product to develop, how to meander around the legal fireworks and secure a viable commercial presence.
作者簡介
Sarfaraz K. Niazi, PhD, is the founding executive chairman of Therapeutic Proteins International LLC, a world-class pure-play developer and manufacturer of biosimilar and interchangeable recombinant biologics, headquartered in Chicago. Dr. Niazi began his career teaching pharmacy at the University of Illinois (1972–1988), where he became a tenured professor. He then entered the pharmaceutical industry at Abbott International, becoming a Volwiler Fellow. He left Abbott in 1995 with a passion for making high-cost biological drugs affordable. Dr. Niazi set up several ex-U.S. biosimilar companies and, in 2003, established Therapeutic Proteins International, the only U.S. integrated company of its kind to date.
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