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Biosimilars: Challenges and path forward

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Abstract

Development of biosimilar proteins is the fastest growing sector in the biopharmaceutical industry, as patents for the top 10 best-selling biologics will expire within one decade. The world’s first biosimilar of infliximab, Remsima® (CT-P13) made by Celltrion, was approved by the Committee for Medicinal Products for Human Use (CHMP) of European Medicine Agency (EMA) in June 2013. This has ignited competition between related companies for prior occupation of the global market on blockbuster biologics. However, to achieve approval for biosimilars, developing companies face many hurdles in process development, manufacturing, analysis, clinical trials, and CMC (chemical, manufacturing and controls) documentation. Recent evolutionary progress in science, engineering, and process technology throughout the biopharmaceutical industry supports to show similarity between originator and biosimilar products. The totality of evidence has been able to demonstrate the quality, efficacy, and safety of biosimilars whereas a lack of interchangeability and international standards has to be addressed. Further understanding of the timing importance by regulatory agencies will be key to maximizing the value of biosimilars.

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Authors and Affiliations

  1. Manufacturing Divisional Group, Celltrion, Inc., Incheon, 406-840, Korea

    Young Sik Kim, Byung Wook Choi, Sung Wook Yang, Sang Wook Nam, Yun Sook Roh, Jae Young Lee, Kyung Jin Lee & Yong Jick Kim

  2. Quality Control Division, Celltrion, Inc., Incheon, 406-840, Korea

    Seon Mi Shin

  3. Department of Biological Engineering, Inha University, Incheon, 402-751, Korea

    Jun-Young Kwon & Dong-Il Kim

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Correspondence to Dong-Il Kim.

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Kim, Y.S., Choi, B.W., Yang, S.W. et al. Biosimilars: Challenges and path forward. Biotechnol Bioproc E 19, 755–765 (2014). https://doi.org/10.1007/s12257-013-0756-8

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