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When a biological drug patent expires, alternative biosimilar products are developed. Biological drugs are different in many respects from drugs based on chemically synthesized small molecules. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is complicated and difficult. This book presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and post-approval issues.

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

Traditional folk medicine practices in China, Hong Kong, Japan and Korea - all located in Northeast Asia - are comparable. Since different usage of a folk medicine may reflect cultural or regional differences, a detailed collation of the folk knowledge of traditional medicine can help to identiy common applications derived from different empirical knowledge as well as variations in appreciation of the value of the same source in different cultural settings. The fourth volume of this book series continues with the objective of collating relevant information for showing the differences and...