Abstract
| Original language | English |
|---|---|
| Article number | 1868078 |
| Journal | MABS |
| Volume | 13 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 2021 |
Keywords
- Biobetter
- CT-P13
- biologic
- biosimilar
- infliximab
- innovative biologics
- value-added medicine
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In: MABS, Vol. 13, No. 1, 1868078, 2021.
Research output: Contribution to journal › Review article › Academic › peer-review
TY - JOUR
T1 - Innovative approaches to biologic development on the trail of CT-P13: biosimilars, value-added medicines, and biobetters
AU - Kim, HoUng
AU - Alten, Rieke
AU - Cummings, Fraser
AU - Danese, Silvio
AU - D’Haens, Geert
AU - Emery, Paul
AU - Ghosh, Subrata
AU - Gilletta de Saint Joseph, Cyrielle
AU - Lee, JongHyuk
AU - Lindsay, James O.
AU - Nikiphorou, Elena
AU - Parker, Ben
AU - Schreiber, Stefan
AU - Simoens, Steven
AU - Westhovens, Rene
AU - Jeong, Ji Hoon
AU - Peyrin-Biroulet, Laurent
N1 - Funding Information: Medical writing support (including development of a draft outline and subsequent drafts in consultation with the authors, assembling tables and figures, collating author comments, copyediting, fact checking, and referencing) was provided by Beatrice Tyrrell, DPhil at Aspire Scientific Limited (Bollington, UK) and funded by Celltrion Healthcare Co., Ltd (Incheon, Republic of Korea). Sang-Wook Yoon, PhD and Dong-Hyeon Kim, PhD from the Medical Communications team at Celltrion Healthcare Co., Ltd, provided suggestions for the initial concept of the article, and reviewed the article for scientific and medical accuracy. The authors had full editorial control of the article and provided final approval of all content. Funding Information: HoUng Kim is employed by and holds stock options in Celltrion Healthcare Co., Ltd. Rieke Alten reports speaker fees and honoraria from Celltrion. Fraser Cummings reports honoraria for advisory boards/lecturing or has received research support from AbbVie, Amgen, AstraZeneca, Celltrion, Gilead, GSK, Hospira/Pfizer, Janssen, MSD, and Takeda. Silvio Danese reports consultancy fees from AbbVie, Allergan, Amgen, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Enthera, Ferring Pharmaceuticals Inc., Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, TiGenix, UCB Inc., and Vifor, and lecture fees from AbbVie, Amgen, Ferring Pharmaceuticals Inc., Gilead, Janssen, Mylan, Pfizer, and Takeda. Geert D’Haens has served as advisor for AbbVie, Ablynx, Active Biotech AB, Agomab Therapeutics, Allergan, Alphabiomics, Amakem, Amgen, AM Pharma, Applied Molecular Therapeutics, Arena Pharmaceuticals, AstraZeneca, Avaxia, Biogen, Bristol Myers Squibb/Celgene, Boehringer Ingelheim, Celltrion, Cosmo, DSM Pharma, Echo Pharmaceuticals, Eli Lilly, Engene, Exeliom Biosciences, Ferring, DrFALK Pharma, Galapagos, Genentech/Roche, Gilead, GlaxoSmithKline, Gossamerbio, Pfizer, Immunic, Johnson & Johnson, Kintai Therapeutics, Lycera, Medimetrics, Takeda, Medtronic, Mitsubishi Pharma, Merck Sharp & Dohme, Mundipharma, Nextbiotics, Novo Nordisk, Otsuka, Photopill, ProciseDx, Prodigest, Prometheus Laboratories/Nestlé, Progenity, Protagonist, RedHill, Robarts Clinical Trials, Salix, Samsung Bioepis, Sandoz, Seres/Nestec/Nestlé, Setpoint, Shire, Teva, Tigenix, Tillotts, Topivert, Versant, and Vifor; received speaker fees from AbbVie, Biogen, Ferring, Galapagos/Gilead, Johnson & Johnson, Merck Sharp & Dohme, Mundipharma, Norgine, Pfizer, Samsung Bioepis, Shire, Millennium/Takeda, Tillotts, and Vifor. Paul Emery has provided expert advice to AbbVie, Amgen, Bristol Myers Squibb, Celltrion, Gilead, Lilly, MSD, Novartis, Pfizer, Roche, Samsung, and Sanofi, and received grants from AbbVie and Bristol Myers Squibb. Subrata Ghosh has received consultancies from AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Galapagos, Gilead, Janssen, Pfizer, Roche, and Takeda, speaker honoraria from AbbVie, Celltrion, Ferring Pharmaceuticals, Janssen, Pfizer, and Takeda, and research grants from AbbVie. Cyrielle Gilletta de Saint Joseph reports personal fees from AbbVie, Janssen, Pfizer, and Takeda. James O. Lindsay has served as consultant and an advisory board participant for AbbVie, Allergan (Warner Chilcott), Atlantic Healthcare, Bristol Myers Squibb, Celgene, Celltrion, Ferring Pharmaceuticals, Gilead, GSK, Janssen, Lilly, MSD, Napp, Pfizer, Shire, Takeda, and Vifor Pharma, has received speaker fees and sponsorship for academic meetings from AbbVie, Allergan (Warner Chilcott), Ferring Pharmaceuticals, Janssen, MSD, Napp, Norgine, Pfizer, Shire, Tillotts Pharma, and Takeda, and has received investigator-led research grants from AbbVie, Gilead, Pfizer, Shire, and Takeda. Elena Nikiphorou has received speaker honoraria and/or participated in advisory boards for AbbVie, Celltrion, Gilead, Lilly, Pfizer, and Sanofi. Ben Parker reports fees and honoraria from AbbVie, Bristol Myers Squibb, Celltrion, Fresenius Kabi, GSK, Lilly, Roche-Chugai, and UCB, and grants from GSK. Stefan Schreiber reports personal fees (consulting in advisory boards) from AbbVie, Arena, BMS, Biogen, Celltrion, Celgene, Falk, Fresenius, Gilead, IMAB, Janssen, MSD, Mylan, Pfizer, Protagonist, Provention Bio, Takeda, and Theravance. Steven Simoens is one of the founders of the KU Leuven Fund on Market Analysis of Biologics and Biosimilars following Loss of Exclusivity (MABEL), was involved in a stakeholder roundtable on biologics and biosimilars sponsored by Amgen, MSD, and Pfizer, has participated in advisory board meetings for Amgen and Pfizer, has contributed to studies on biologics and biosimilars for Celltrion, Hospira, Mundipharma, and Pfizer, had speaking engagements for Amgen, Celltrion and Sandoz, and is a member of the leadership team of the ISPOR Special Interest Group on Biosimilars. Rene Westhovens has participated in advisory boards and speakers bureau for Celltrion and Galapagos/Gilead. Laurent Peyrin-Biroulet reports personal fees from AbbVie, Allergan, Alma, Amgen, Applied Molecular Transport, Arena, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Enterome, Enthera, Ferring Pharmaceuticals, Fresenius Kabi, Genentech, Gilead, Hikma, Index Pharmaceuticals, Janssen, Lilly, MSD, Mylan, Nestlé, Norgine, Oppilan Pharma, OSE Immunotherapeutics, Pfizer, Pharmacosmos, Roche, Samsung Bioepis, Sandoz, Sterna, Sublimity Therapeutics, Takeda, Theravance, Tillotts, and Vifor, and grants from AbbVie, MSD, and Takeda. JongHyuk Lee and Ji Hoon Jeong report no conflicts of interest. Publisher Copyright: © 2021 The Author(s). Published with license by Taylor & Francis Group, LLC.
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - Biobetter
KW - CT-P13
KW - biologic
KW - biosimilar
KW - infliximab
KW - innovative biologics
KW - value-added medicine
UR - http://www.scopus.com/inward/record.url?scp=85101100080&partnerID=8YFLogxK
U2 - https://doi.org/10.1080/19420862.2020.1868078
DO - https://doi.org/10.1080/19420862.2020.1868078
M3 - Review article
C2 - 33557682
SN - 1942-0862
VL - 13
JO - MABS
JF - MABS
IS - 1
M1 - 1868078
ER -