Innovative Approaches to Biologic Development on the Trail of CT-P13: Biosimilars, Value-added Medicines, and Biobetters

Overview

Journal MAbs

Specialty Allergy & Immunology

Date 2021 Feb 9

PMID 33557682

Citations 11

Authors

HoUng Kim

Rieke Alten

Fraser Cummings

Silvio Danese

Geert DHaens

Paul Emery

Subrata Ghosh

Cyrielle Gilletta De Saint Joseph

Jonghyuk Lee

James O Lindsay

Elena Nikiphorou

Ben Parker

Stefan Schreiber

Steven Simoens

Rene Westhovens

Ji Hoon Jeong

Laurent Peyrin-Biroulet

Affiliations

Soon will be listed here.

Abstract

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.

Citing Articles

Effectiveness of switching to subcutaneous infliximab in inflammatory bowel disease patients with inadequate biochemical response during intravenous administration.

Lee B, Kim M, Ran Kim E, Hong S, Kyung Chang D, Kim Y Sci Rep. 2024; 14(1):24347.

PMID: 39420116 PMC: 11487171. DOI: 10.1038/s41598-024-75693-7.

Subcutaneous infliximab in Crohn's disease patients with previous immunogenic failure of intravenous infliximab.

Husman J, Cerna K, Matthes K, Gilger M, Arsova M, Schmidt A Int J Colorectal Dis. 2024; 39(1):151.

PMID: 39317813 PMC: 11422436. DOI: 10.1007/s00384-024-04727-3.

Subcutaneous Infliximab Monotherapy Versus Combination Therapy with Immunosuppressants in Inflammatory Bowel Disease: A Post Hoc Analysis of a Randomised Clinical Trial.

DHaens G, Reinisch W, Schreiber S, Cummings F, Irving P, Ye B Clin Drug Investig. 2023; 43(4):277-288.

PMID: 37004656 PMC: 10066948. DOI: 10.1007/s40261-023-01252-z.

Efficacy of subcutaneous vs intravenous infliximab in rheumatoid arthritis: a post-hoc analysis of a randomized phase III trial.

Constantin A, Caporali R, Edwards C, Fonseca J, Iannone F, Keystone E Rheumatology (Oxford). 2022; 62(8):2838-2844.

PMID: 36534825 PMC: 10393429. DOI: 10.1093/rheumatology/keac689.

Therapeutic Drug Monitoring of Subcutaneous Infliximab in Inflammatory Bowel Disease-Understanding Pharmacokinetics and Exposure Response Relationships in a New Era of Subcutaneous Biologics.

Little R, Ward M, Wright E, Jois A, Boussioutas A, Hold G J Clin Med. 2022; 11(20).

PMID: 36294494 PMC: 9605309. DOI: 10.3390/jcm11206173.

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