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.
Notes
Description based upon print version of record.
Bibliographic references
Includes bibliographical references at the end of each chapters.
Source of description
Description based on print version record.
Language note
English
Contents
Introduction to biosimilar and interchangeable products
Intellectual property issues
The EMA regulatory guidance
EMA approved biosimilars
The FDA regulatory guidance
The ROW regulatory guidance
US commercialization
Global commercialization
Quality and lifecycle management.
ISBN
1-351-22887-0
1-351-23130-8
1-4987-4348-X
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