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.
General
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