Biosimilar drug product development
Publication
, Chapter
Endrenyi, L; Declerck, PJ; Chow, SC
January 1, 2017
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.
Duke Scholars
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DOI
ISBN
9781498718790
Publication Date
January 1, 2017
Start / End Page
1 / 477
Citation
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Endrenyi, L., Declerck, P. J., & Chow, S. C. (2017). Biosimilar drug product development (pp. 1–477). https://doi.org/10.1201/9781315119878
Endrenyi, L., P. J. Declerck, and S. C. Chow. “Biosimilar drug product development,” 1–477, 2017. https://doi.org/10.1201/9781315119878.
Endrenyi L, Declerck PJ, Chow SC. Biosimilar drug product development. In 2017. p. 1–477.
Endrenyi, L., et al. Biosimilar drug product development. 2017, pp. 1–477. Scopus, doi:10.1201/9781315119878.
Endrenyi L, Declerck PJ, Chow SC. Biosimilar drug product development. 2017. p. 1–477.
DOI
ISBN
9781498718790
Publication Date
January 1, 2017
Start / End Page
1 / 477