Innovative approaches to biologic development on the trail of CT-P13: biosimilars, value-added medicines, and biobetters

The biosimilar concept is now well established. Clinical data accumulated pre- and post-approval have supported biosimilar uptake, in turn stimulating competition in the biologics market and increasing patient access to biologics. Following technological advances, other innovative biologics, such as...

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Main Authors: HoUng Kim (Author), Rieke Alten (Author), Fraser Cummings (Author), Silvio Danese (Author), Geert D'Haens (Author), Paul Emery (Author), Subrata Ghosh (Author), Cyrielle Gilletta de Saint Joseph (Author), JongHyuk Lee (Author), James O. Lindsay (Author), Elena Nikiphorou (Author), Ben Parker (Author), Stefan Schreiber (Author), Steven Simoens (Author), Rene Westhovens (Author), Ji Hoon Jeong (Author), Laurent Peyrin-Biroulet (Author)
Format: Book
Published: Taylor & Francis Group, 2021-01-01T00:00:00Z.
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100 1 0 |a HoUng Kim  |e author 
700 1 0 |a Rieke Alten  |e author 
700 1 0 |a Fraser Cummings  |e author 
700 1 0 |a Silvio Danese  |e author 
700 1 0 |a Geert D'Haens  |e author 
700 1 0 |a Paul Emery  |e author 
700 1 0 |a Subrata Ghosh  |e author 
700 1 0 |a Cyrielle Gilletta de Saint Joseph  |e author 
700 1 0 |a JongHyuk Lee  |e author 
700 1 0 |a James O. Lindsay  |e author 
700 1 0 |a Elena Nikiphorou  |e author 
700 1 0 |a Ben Parker  |e author 
700 1 0 |a Stefan Schreiber  |e author 
700 1 0 |a Steven Simoens  |e author 
700 1 0 |a Rene Westhovens  |e author 
700 1 0 |a Ji Hoon Jeong  |e author 
700 1 0 |a Laurent Peyrin-Biroulet  |e author 
245 0 0 |a Innovative approaches to biologic development on the trail of CT-P13: biosimilars, value-added medicines, and biobetters 
260 |b Taylor & Francis Group,   |c 2021-01-01T00:00:00Z. 
500 |a 10.1080/19420862.2020.1868078 
500 |a 1942-0870 
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520 |a The biosimilar concept is now well established. Clinical data accumulated pre- and post-approval have supported biosimilar uptake, in turn stimulating competition in the biologics market and increasing patient access to biologics. Following technological advances, other innovative biologics, such as "biobetters" or "value-added medicines," are now reaching the market. These innovative biologics differ from the reference product by offering additional clinical or non-clinical benefits. We discuss these innovative biologics with reference to CT-P13, initially available as an intravenous (IV) biosimilar of reference infliximab. A subcutaneous (SC) formulation, CT-P13 SC, has now been developed. Relative to CT-P13 IV, CT-P13 SC offers clinical benefits in terms of pharmacokinetics, with comparable efficacy, safety, and immunogenicity, as well as increased convenience for patients and reduced demands on healthcare system resources. As was once the case for biosimilars, nomenclature and regulatory pathways for innovative biologics require clarification to support their uptake and ultimately benefit patients. 
546 |a EN 
690 |a Biobetter 
690 |a biologic 
690 |a biosimilar 
690 |a CT-P13 
690 |a infliximab 
690 |a innovative biologics 
690 |a Therapeutics. Pharmacology 
690 |a RM1-950 
690 |a Immunologic diseases. Allergy 
690 |a RC581-607 
655 7 |a article  |2 local 
786 0 |n mAbs, Vol 13, Iss 1 (2021) 
787 0 |n https://www.tandfonline.com/doi/10.1080/19420862.2020.1868078 
787 0 |n https://doaj.org/toc/1942-0862 
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