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Hannah A Blair, Emma D Deeks
Infliximab biosimilar (CT-P13/infliximab-dyyb; Remsima(®), Inflectra(®)) is approved in several countries for use in all indications for which reference infliximab (Remicade(®)) is approved, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis, psoriasis, Crohn's disease, and ulcerative colitis. Clinical data contributing to the EU approval of infliximab biosimilar were obtained from two pivotal double-blind clinical trials in patients with AS (PLANETAS) or RA (PLANETRA)...
October 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Christina Y Ha, Asher Kornbluth
On February 9, 2016, the Food and Drug Administration Arthritis Advisory Committee recommended by a vote of 21 to 3, that the biosimilar to infliximab, CT-P13, be approved for rheumatoid arthritis and ankylosing spondylitis and, by extrapolation, for all the indications for which infliximab is currently approved, including adult and pediatric ulcerative colitis and Crohn's disease. On April 5, 2016, the Food and Drug Administration concurred with this recommendation and approved CT-P13 (Inflectra; Pfizer Inc...
October 2016: Inflammatory Bowel Diseases
Kornelius Schulze, Nadine Koppka, Frederik Lutter, Gunnar Brandhorst, Stefan Schreiber, Ulf Helwig
The approval of infliximab biosimilars Remsima™ and Inflectra™ (CT-P13) for patients with inflammatory bowel disease (IBD) is a promising step to reduce treatment costs. Since monitoring of Remicade™ serum trough levels and anti-Remicade™ immunogenicity hold an important significance in treatment modalities, no data about monitoring of drug serum trough levels or anti-drug antibody levels in IBD patients treated with Remsima™ or Inflectra™ are present to date. Therefore, in this study we applied a Remicade™-validated ELISA to determine drug serum levels of Remsima™ or Inflectra™...
September 2016: Biologicals: Journal of the International Association of Biological Standardization
Mary Choy
Defibrotide sodium (Defitelio) for hepatic veno-occlusive disease; emtricitabine/tenofovir alafenamide (Descovy) for human immunodeficiency virus infection; and infliximabdyyb (Inflectra) for Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
July 2016: P & T: a Peer-reviewed Journal for Formulary Management
Jing Fang, Catalin Doneanu, William R Alley, Ying Qing Yu, Alain Beck, Weibin Chen
In this study, we demonstrate the utility of ultra-performance liquid chromatography coupled to mass spectrometry (MS) and ion-mobility spectrometry (IMS) to characterize and compare reference and biosimilar monoclonal antibodies (mAbs) at an advanced level. Specifically, we focus on infliximab and compared the glycan profiles, higher order structures, and their host cell proteins (HCPs) of the reference and biosimilar products, which have the brand names Remicade® and Inflectra®, respectively. Overall, the biosimilar attributes mirrored those of the reference product to a very high degree...
August 2016: MAbs
Dae Hyun Yoo, Nenad Prodanovic, Janusz Jaworski, Pedro Miranda, Edgar Ramiterre, Allan Lanzon, Asta Baranauskaite, Piotr Wiland, Carlos Abud-Mendoza, Boycho Oparanov, Svitlana Smiyan, HoUng Kim, Sang Joon Lee, SuYeon Kim, Won Park
OBJECTIVES: To assess the efficacy and safety of switching from the infliximab reference product (RP; Remicade) to its biosimilar CT-P13 (Remsima, Inflectra) or continuing CT-P13 in patients with rheumatoid arthritis (RA) for an additional six infusions. METHODS: This open-label extension study recruited patients with RA who had completed the 54-week, randomised, parallel-group study comparing CT-P13 with RP (PLANETRA; NCT01217086). CT-P13 (3 mg/kg) was administered intravenously every 8 weeks from weeks 62 to 102...
April 29, 2016: Annals of the Rheumatic Diseases
Radan Keil, Martin Wasserbauer, Zdena Zádorová, Jan Hajer, Pavel Drastich, Pavel Wohl, Marek Beneš, Martina Bojková, Pavel Svoboda, Michal Konečný, Přemysl Falt, Tomáš Vaňásek, Martin Pešta, František Pešek, Luděk Bouchner, Jana Koželuhová, Aleš Novotný, Lucie Bartůsková, Julius Špičák
OBJECTIVE: The infliximab biosimilar CT-P13 (Remsima(®), Inflectra(®)) was approved in Europe for the treatment of inflammatory bowel disease (IBD) based on extrapolation of data from patients with rheumatic disease. Because there are limited published reports on clinical outcomes for IBD patients treated with CT-P13, we monitored responses to induction treatment with this biosimilar in patients with Crohn's disease (CD) or ulcerative colitis (UC) in centres across the Czech Republic...
September 2016: Scandinavian Journal of Gastroenterology
Gerassimos J Mantzaris
In the last 20 years, the advent of anti-tumor necrosis factor alpha (TNFα) biologics has revolutionized the treatment of patients with inflammatory bowel disease (IBD) but the cost of biologic therapy now constitutes a large proportion of all healthcare expenditures. Patent expiration has sparked the healthcare industry's interest in the production of biosimilar (BS) versions of first generation biologics (originators [ORGs]) for market sharing. Having no access to the production line of the ORG, the sponsor of a BS needs to develop his own manufacturing process to produce a highly similar version of the reference product...
2016: Digestive Diseases
M Begoña Ruiz-Argüello, Ainara Maguregui, Ainhoa Ruiz Del Agua, Dora Pascual-Salcedo, Ana Martínez-Feito, Teresa Jurado, Chamaida Plasencia, Alejandro Balsa, Francisca Llinares-Tello, José Rosas, Nerea Torres, Antonio Martínez, Daniel Nagore
OBJECTIVES: The aim of this study was to determine whether antibodies to infliximab (IFX) in Remicade-treated patients cross-react with the biosimilar CT-P13. METHODS: 250 consecutive patients with rheumatic diseases under Remicade and 77 controls were retrospectively selected for the study. Anti-IFX antibodies at drug through levels were measured in parallel with three different bridging ELISA assays: Promonitor-ANTI-IFX kit, which uses Remicade to detect antibodies, and two more assays that use either Inflectra or Remsima with the same format...
September 2016: Annals of the Rheumatic Diseases
Ann Gils, Thomas Van Stappen, Erwin Dreesen, Ruth Storme, Séverine Vermeire, Paul J Declerck
BACKGROUND: The availability of an infliximab ELISA for measuring the originator drug Remicade and its biosimilars, such as Remsima and Inflectra (CT-P13), would facilitate the implementation of therapeutic drug monitoring of biosimilars and enhance the extrapolation of treatment stratification algorithms established for Remicade. A universal calibrator for all anti-infliximab antibody bridging assays allows harmonization of anti-drug antibody titers. METHODS: A panel of 55 mouse monoclonal antibodies raised against Remicade, including MA-IFX6B7 and MA-IFX10F9, were evaluated for their reactivity toward the biosimilars using a sandwich-type ELISA and surface plasmon resonance...
April 2016: Inflammatory Bowel Diseases
Won Park, Dae Hyun Yoo, Janusz Jaworski, Jan Brzezicki, Andriy Gnylorybov, Vladimir Kadinov, Irmgadt Goecke Sariego, Carlos Abud-Mendoza, William Jose Otero Escalante, Seong Wook Kang, Daina Andersone, Francisco Blanco, Seung Suh Hong, Sun Hee Lee, Jürgen Braun
BACKGROUND: CT-P13 (Remsima®, Inflectra®) is a biosimilar of the infliximab reference product (RP; Remicade®) and is approved in Europe and elsewhere, mostly for the same indications as RP. The aim of this study was to compare the 54-week efficacy, immunogenicity, pharmacokinetics (PK) and safety of CT-P13 with RP in patients with ankylosing spondylitis (AS), with a focus on patient-reported outcomes (PROs). METHODS: This was a multinational, double-blind, parallel-group study in patients with active AS...
2016: Arthritis Research & Therapy
Ji Soo Kim, Sung Hwan Kim, ByoungOh Kwon, SeungSuh Hong
Anti-drug antibodies against biologic drugs affect efficacy and safety; therefore, it is important to use appropriate assays for immunogenicity testing in clinical studies. This review describes the electrochemiluminescent (ECL) immunoassay, ELISA, radioimmunoassay, and homogeneous mobility shift assay. The characteristics of ECL, used to assess immunogenicity in comparison trials of CT-P13 (Remsima(®), Inflectra(®)) versus its reference medicinal product, infliximab (Remicade(®)), are also compared with the other assays, based on published literature...
2015: Expert Review of Clinical Immunology
Won Park, Sang Joon Lee, Jihye Yun, Dae Hyun Yoo
OBJECTIVE: To compare the pharmacokinetics (PK), safety and tolerability of biosimilar infliximab (CT-P13 [Remsima(®), Inflectra(®)]) with two formulations of the reference medicinal product (RMP) (Remicade(®)) from either Europe (EU-RMP) or the USA (US-RMP). METHODS: This was a double-blind, three-arm, parallel-group study (EudraCT number: 2013-003173-10). Healthy subjects received single doses (5 mg/kg) of CT-P13 (n = 71), EU-RMP (n = 71) or US-RMP (n = 71)...
2015: Expert Review of Clinical Immunology
Dae Hyun Yoo, Choongseob Oh, SeungSuh Hong, Won Park
OBJECTIVE: To examine whether efficacy, safety and pharmacokinetic (PK) data observed with CT-P13 (Remsima(®); Inflectra(®)), an infliximab biosimilar, are similar to those from published reports with the reference medicinal product (RMP; Remicade(®)) in patients with rheumatoid arthritis (RA) or ankylosing spondylitis (AS). METHODS: Literature searches were performed to identify clinical studies with infliximab RMP. Efficacy, safety and PK data were indirectly compared with data from head-to-head clinical trials of CT-P13 and RMP...
2015: Expert Review of Clinical Immunology
Ulf Müller-Ladner, SeungSuh Hong, Choongseob Oh, Peter Taylor
Biosimilars are drugs developed to be highly similar to their originator biologic (or 'reference medicinal product') with no clinically meaningful differences in purity, efficacy or safety. Production of biologics and biosimilars is highly complex and sensitive, with any change in manufacturing process having a potential impact on efficacy and safety. This review provides an overview of the manufacturing process for these drugs and considers the implications of any process changes. The scientific rationale underlying the regulatory comparability exercise for process-changed reference medicinal products and biosimilars is also discussed, as is the issue of 'switchability' from a reference medicinal product to its biosimilar...
2015: Expert Review of Clinical Immunology
Peter Taylor
The development of biologic drugs has undoubtedly enhanced the spectrum of treatments available for immune-mediated inflammatory rheumatic diseases such as rheumatoid arthritis. However, despite their clear clinical benifits, use of biologics is often hindered by their high costs. The manufacture and subsequent approval of more cost-effective 'biosimilar' versions of these drugs may address this issue and improve patient access. CT-P13 (Remsima(®), Inflectra(®)), a biosimilar of infliximab (Remicade(®)), has shown comparable efficacy, safety and pharmacokinetics to its originator drug in clinical studies...
2015: Expert Review of Clinical Immunology
Shomron Ben-Horin, Graham A Heap, Tariq Ahmad, HoUng Kim, TaekSang Kwon, Yehuda Chowers
Biopharmaceuticals or 'biologics' have revolutionized the treatment of many diseases. However, some patients generate an immune response to such drugs, potentially limiting clinical efficacy and safety. Infliximab (Remicade(®)) is a monoclonal antibody used to treat several immune-mediated inflammatory disorders. A biosimilar of infliximab, CT-P13 (Remsima(®), Inflectra(®)), has recently been approved in Europe for all indications in which infliximab is approved. Approval of CT-P13 was based in part on extrapolation of clinical trial data from two indications (rheumatoid arthritis and ankylosing spondylitis) to all other indications, including inflammatory bowel disease...
2015: Expert Review of Gastroenterology & Hepatology
Walter Reinisch, Edouard Louis, Silvio Danese
Extrapolation of clinical data from other indications is an important concept in the development of biosimilars. This process depends on strict comparability exercises to establish similarity to the reference medicinal product. However, the extrapolation paradigm has prompted a fierce scientific debate. CT-P13 (Remsima(®), Inflectra(®)), an infliximab biosimilar, is a TNF antagonist used to treat immune-mediated inflammatory diseases. On the basis of totality of similarity data, the EMA approved CT-P13 for all indications held by its reference medicinal product (Remicade(®)) including inflammatory bowel disease...
2015: Expert Review of Gastroenterology & Hepatology
Stefan Schreiber, Julian Panés, ByoungOh Kwon, SeungSuh Hong, Laurent Peyrin-Biroulet
The introduction of biologic drugs represents the most significant advance in the management of immune-mediated inflammatory diseases for a decade. However, complex proteins are expensive to produce and manufacture. Biosimilar versions of established biologics are becoming available as another version of the reference medicinal product and are expected to provide substantial cost savings. However, because of their complexity, the approval of biosimilars requires strict controls to ensure that all therapeutically relevant characteristics are comparable to the reference medicinal product...
2015: Expert Review of Gastroenterology & Hepatology
Huub Schellekens, Erika Lietzan, Freddy Faccin, Jaap Venema
INTRODUCTION: Biosimilars are biologic products that receive authorization based on an abbreviated regulatory application containing comparative quality and nonclinical and clinical data that demonstrate similarity to a licensed biologic product. Extrapolation of safety and efficacy has emerged as an important way to simplify biosimilar development. Regulatory authorities have generally reached the consensus that extrapolation of similarity from one indication to other approved indications of the reference product can be permitted if it is scientifically justified...
2015: Expert Opinion on Biological Therapy
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