Description
Biosimilar Drug Product Development
Drugs and the Pharmaceutical Sciences Series
Coordinators: Endrenyi Laszlo, Declerck Dr. Paul, Chow Shein-Chung
Language: English
Subject for Biosimilar Drug Product Development:
Keywords
Biosimilar Product; Biosimilar drug product development; Reference Product; Biosimilar drug product approval process; Analytical Similarity Assessment; Quality assurance of biosimilar drugs; Biosimilar Medicinal Product; Immunogenicity; Similar Biological Medicinal Products; Interchangeability; Reference Medicinal Product; Pharmacovigilance; BPCI Act; Paul Declerck; Biosimilarity Index; Shein-Chung Chow; Ich Q5E; Steven A; Berkowitz; Biological Medicinal Product; Li Liu; Fundamental Bioequivalence Assumption; Roy Jefferis; IgG Molecule; Alan Fauconnier; IBE; Lyudmil Antonov; Biosimilar Infliximab; Karen De Smet; Biosimilar Pathway; Leon AGJM van Aerts; Biosimilar Candidate; Mark McCamish; ADA Response; Gillian Woollett; Drug Interchangeability; Sigrid Balser; FDA Draft Guidance; Fuyu Song; Medicinal Products; Jian Wang; Drug Products; Wallace Lauzon; Native MS; Catherine Njue; ADA Formation; Agnes V; Klein; Animal Studies; Paul Chamberlain; Biosimilar mAbs; Shehla Hashim; Souleh Semalulu; Felix Omara; Duc Vu; Noel Courage; Lynn C; Tyler; Sol Ruiz; Erwin A; Blackstone; Joseph P; Fuhr; Kenny K; Y; So; Michael R; Marit; Michael D; McLean; J; Christopher Hall
Publication date: 06-2020
· 15.6x23.4 cm · Paperback
Publication date: 03-2017
· 15.6x23.4 cm · Hardback
Description
/li>Contents
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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.
Analytical characterization. Immunogenicity. Animal studies. Clinical development. Manufacturing, process control. Extrapolation of indications. Interchangeability, substitution. Pharmacovigilance. Statistical issues. Regulatory issues.