Biosimilars and Interchangeable Biologics: Strategic Elements

ISBN-13: 9781138775503 / Angielski / Miękka / 2017 / 646 str.

Sarfaraz K. Niazi

Opis

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.

Spis treści

Introduction to Biosimilar and Interchangeable Products. Intellectual Property Issues for Biosimilars. European Regulatory Guidance. EMA-Approved Biosimilars. FDA Regulatory Guidance. ROW Regulatory Guidance. US Commercialization. Global Commercialization. Quality and Lifecycle Management.

O autorze

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.