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- W1971014721 abstract "Biopharmaceuticals are much more complex than small-molecule drugs, which raises challenging questions for the development and regulatory evaluation of follow-on versions (also known as biosimilars). Jones and colleagues discuss the current state of the art in analytical technologies to assess three characteristics of protein biopharmaceuticals that regulatory authorities have identified as being important for biosimilars: post-translational modifications, three-dimensional structures and protein aggregation. Biologics such as monoclonal antibodies are much more complex than small-molecule drugs, which raises challenging questions for the development and regulatory evaluation of follow-on versions of such biopharmaceutical products (also known as biosimilars) and their clinical use once patent protection for the pioneering biologic has expired. With the recent introduction of regulatory pathways for follow-on versions of complex biologics, the role of analytical technologies in comparing biosimilars with the corresponding reference product is attracting substantial interest in establishing the development requirements for biosimilars. Here, we discuss the current state of the art in analytical technologies to assess three characteristics of protein biopharmaceuticals that regulatory authorities have identified as being important in development strategies for biosimilars: post-translational modifications, three-dimensional structures and protein aggregation." @default.
- W1971014721 created "2016-06-24" @default.
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- W1971014721 creator A5072507764 @default.
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- W1971014721 creator A5082763070 @default.
- W1971014721 date "2012-06-29" @default.
- W1971014721 modified "2023-10-18" @default.
- W1971014721 title "Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars" @default.
- W1971014721 cites W1513846695 @default.
- W1971014721 cites W1554789346 @default.
- W1971014721 cites W1966227539 @default.
- W1971014721 cites W1966687213 @default.
- W1971014721 cites W1967340631 @default.
- W1971014721 cites W1967681366 @default.
- W1971014721 cites W1968014420 @default.
- W1971014721 cites W1968154997 @default.
- W1971014721 cites W1969638854 @default.
- W1971014721 cites W1970750126 @default.
- W1971014721 cites W1972392744 @default.
- W1971014721 cites W1974900044 @default.
- W1971014721 cites W1975086142 @default.
- W1971014721 cites W1975267705 @default.
- W1971014721 cites W1976736354 @default.
- W1971014721 cites W1977283614 @default.
- W1971014721 cites W1979325667 @default.
- W1971014721 cites W1979942247 @default.
- W1971014721 cites W1980442616 @default.
- W1971014721 cites W1980770700 @default.
- W1971014721 cites W1984152779 @default.
- W1971014721 cites W1984402172 @default.
- W1971014721 cites W1985440252 @default.
- W1971014721 cites W1990596938 @default.
- W1971014721 cites W1991302621 @default.
- W1971014721 cites W1993203458 @default.
- W1971014721 cites W1994494141 @default.
- W1971014721 cites W1995692089 @default.
- W1971014721 cites W1996334859 @default.
- W1971014721 cites W1998274795 @default.
- W1971014721 cites W1999139162 @default.
- W1971014721 cites W1999203246 @default.
- W1971014721 cites W2001607896 @default.
- W1971014721 cites W2003261719 @default.
- W1971014721 cites W2007228224 @default.
- W1971014721 cites W2008138329 @default.
- W1971014721 cites W2009186331 @default.
- W1971014721 cites W2013209780 @default.
- W1971014721 cites W2015060415 @default.
- W1971014721 cites W2015082998 @default.
- W1971014721 cites W2016086874 @default.
- W1971014721 cites W2018808382 @default.
- W1971014721 cites W2023115763 @default.
- W1971014721 cites W2023749561 @default.
- W1971014721 cites W2026084484 @default.
- W1971014721 cites W2027949071 @default.
- W1971014721 cites W2028049825 @default.
- W1971014721 cites W2028161249 @default.
- W1971014721 cites W2034171722 @default.
- W1971014721 cites W2034455355 @default.
- W1971014721 cites W2035123840 @default.
- W1971014721 cites W2035546135 @default.
- W1971014721 cites W2037590265 @default.
- W1971014721 cites W2038733502 @default.
- W1971014721 cites W2041076448 @default.
- W1971014721 cites W2042119692 @default.
- W1971014721 cites W2042601819 @default.
- W1971014721 cites W2042974448 @default.
- W1971014721 cites W2043492633 @default.
- W1971014721 cites W2044550135 @default.
- W1971014721 cites W2047418952 @default.
- W1971014721 cites W2047565601 @default.
- W1971014721 cites W2048981144 @default.
- W1971014721 cites W2049324939 @default.
- W1971014721 cites W2049364321 @default.
- W1971014721 cites W2049681010 @default.
- W1971014721 cites W2050716373 @default.
- W1971014721 cites W2051047940 @default.
- W1971014721 cites W2051129711 @default.
- W1971014721 cites W2051764215 @default.
- W1971014721 cites W2059062957 @default.
- W1971014721 cites W2059918071 @default.
- W1971014721 cites W2061187228 @default.
- W1971014721 cites W2063366729 @default.
- W1971014721 cites W2065897299 @default.
- W1971014721 cites W2066736637 @default.
- W1971014721 cites W2071095038 @default.
- W1971014721 cites W2071674498 @default.
- W1971014721 cites W2077427047 @default.
- W1971014721 cites W2079666345 @default.
- W1971014721 cites W2079704217 @default.
- W1971014721 cites W2080611602 @default.
- W1971014721 cites W2080784587 @default.
- W1971014721 cites W2082419091 @default.
- W1971014721 cites W2083344986 @default.
- W1971014721 cites W2085359013 @default.
- W1971014721 cites W2086966539 @default.
- W1971014721 cites W2088333110 @default.
- W1971014721 cites W2090640604 @default.