Biosimilars: Challenges and path forward

Biotechnology and Bioprocess Engineering

Volumn 19, Issue 5, 2014, Pages 755-765

  Kim, Young Sik ^a   Choi, Byung Wook ^a   Yang, Sung Wook ^a   Shin, Seon Mi ^a   Nam, Sang Wook ^a   Roh, Yun Sook ^a   Lee, Jae Young ^a   Lee, Kyung Jin ^a   Kim, Yong Jick ^a   Kwon, Jun Young ^b   Kim, Dong Il ^b  

^a Celltrion Inc   (South Korea)

^b Inha University   (South Korea)

Author keywords

biopharmaceutical; biosimilar; follow on biologics; innovator biological products; interchangeability; international non proprietary name (INN); monoclonal antibody; reference medicinal product (RMP)

Indexed keywords

INTERNATIONAL TRADE; MANUFACTURE; MONOCLONAL ANTIBODIES;

BIOLOGICAL PRODUCTS; BIOPHARMACEUTICAL; BIOSIMILAR; FOLLOW-ON BIOLOGICS; INTERCHANGEABILITY; INTERNATIONAL NON-PROPRIETARY NAME (INN); MEDICINAL PRODUCTS;

CHEMICAL ANALYSIS;

BIOSIMILAR AGENT;

ANALYTIC METHOD; CLINICAL TRIAL (TOPIC); CONTAINER; CONTAINER CLOSURE SYSTEM; DRUG DELIVERY DEVICE; DRUG EFFICACY; DRUG FORMULATION; DRUG MANUFACTURE; DRUG QUALITY; DRUG SAFETY; EUROPE; HUMAN; PROCESS CONTROL; PROCESS DEVELOPMENT; PROCESS TECHNOLOGY; REFERENCE VALUE; REVIEW; STANDARD;

EID: 84911404316     PISSN: 12268372     EISSN: 19763816     Source Type: Journal    
DOI: 10.1007/s12257-013-0756-8     Document Type: Review

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