Author byline as per print journal: Valderílio Feijó Azevedo1,2, Alejandra Babini3,4, Fabio Vieira Teixeira5,6, Igor Age Kos1,2, Pablo Matar7
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Introduction: The Latin American Forum on Biosimilars (FLAB) is an annual meeting that brings together various stakeholders, including key opinion leaders, the pharmaceutical industry, academics, patients, lawyers and other healthcare professionals, to present and discuss recent findings regarding biosimilars. In 2015, the meeting theme was interchangeability and automatic substitution. Regarding biosimilarity, interchangeability and extrapolation of indications, the discussion centred on two products in Brazil and Argentina: CT-P13, an infliximab biosimilar; and RTXM83, a rituximab biosimilar. Here, we conduct a critical analysis of the available scientific and medical information on these products to establish a FLAB position statement in the context of the current regulations in Brazil and Argentina. |
Submitted: 15 March 2016; Revised: 30 May 2016; Accepted: 31 May 2016; Published online first: 13 June 2016
The annual Latin American Forum on Biosimilars (FLAB) was first held in 2010 with the aim of bringing key stakeholders within the community together to discuss aspects of biosimilars. Attended by key opinion leaders, representatives from the pharmaceutical industry, academics, patients, lawyers and healthcare professionals, FLAB is sponsored or supported by different organizations, including the pharmaceutical industry such as AbbVie, Janssen, Pfizer, Sandoz, Sanofi; patient organizations and Latin American medical societies such as Brazilian Society of Rheumatology, Argentinian Society of Rheumatology, GEDIB (Brazilian Study Group of Inflammatory Bowel Diseases) among others; some regulatory agencies such as ANVISA (Agencia Nacional de Vigilancia Sanitaria), COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), ANAMED (Agencia Nacional de Medicamentos), have sent representatives to the Forum in order to discuss regulatory aspects of biosimilars approved in their countries. The 2015 meeting was held in Brasília, Brazil, with the theme of ‘Interchangeability and Automatic Substitution’, and saw the approval of two potential biosimilars in different Latin American countries.
The World Health Organization (WHO) defines similar biotherapeutic products (SBPs) as products that are similar in terms of quality, safety and efficacy to an already-licensed reference biotherapeutic product (RBP) [1]. An SBP is tested for biosimilarity via a biosimilarity exercise in which it is compared with existing products using the same procedures. Within this biosimilarity exercise, there are three levels of evaluation: quality evaluation (i.e. physicochemical and biological characterization), non-clinical evaluation and clinical evaluation. Clinical evaluation seeks to demonstrate the comparable safety and efficacy of the SBP with the RBP. It is a stepwise procedure that begins with pharmacokinetic (PK) and pharmacodynamic (PD) studies, followed by efficacy and safety clinical trial(s). Given that biotherapeutic products are biologically active molecules capable of inducing immune responses, immunogenicity is an important consideration within the evaluation of safety. In our opinion, all biological products supported by a full biosimilarity exercise can be considered true biosimilars. Conversely, products that are not fully supported by scientific information, including comparative clinical data, cannot be considered biosimilars.
In Europe, a similar definition has been established that states: ‘biosimilars are copy biologicals with a clear and effective regulatory route for approval, which allows marketing of safe and efficacious biological products’ [2]. This conceptual idea has been well established by the European Medicines Agency’s (EMA) guidelines [3], which have led to the approval of several biosimilars in Europe, including the first biosimilar monoclonal antibody (mAb), the anti-tumour necrosis factor (anti-TNF) drug infliximab. In September 2013, the Committee for Medicinal Products for Human Use (CHMP) of EMA, approved the use of biosimilar of Remicade™ under the trade names of Remsima™ and Inflectra™ [4, 5].
Other biosimilar mAbs and fusion proteins that are currently being investigated include: rituximab, which is in the early stages of clinical trials; and adalimumab and etanercept, which are in phase III clinical trials.
The main objective of this paper is to provide a critical analysis of the results of the biosimilarity exercises carried out on two products that have been recently approved in Brazil and Argentina: CT-P13, an infliximab biosimilar; and RTXM83, a proposed rituximab biosimilar. As a result, we have established a FLAB position statement on the approval of these drugs in the context of the current regulations in Brazil and Argentina.
At present, a number of countries in Latin America have specific regulations concerning the approval of SBPs (Argentina, Brazil, Chile, Costa Rica, Cuba, Guatemala, Mexico, Panama, Peru and Venezuela). In general, regulations consider the international standards set out by EMA, in combination with local input and scientific principles based on WHO guidelines. Most legislation for biosimilar approval considers it essential to implement a system of pharmacovigilance after product commercialization, to ensure that the safety and efficacy of biosimilars can be evaluated [6].
In Argentina, resolutions outlining the requirements for biopharmaceuticals and biosimilar products (No. 7075 [7] and 7729 [8]) were published in 2011 by the ANMAT. Resolution No. 7729 specifically states the requirements for the approval of biosimilars. Of note, Article 6 states that the comparative exercise between the reference product and proposed biosimilar must be accompanied by non-clinical and clinical studies in order to be approved. In 2012, ANMAT enacted Resolution No. 3397, which established the requirements for the approval of biological medicines obtained using DNA recombinant technology, including mAbs [9].
In 2013, the Brazil-based pharmaceutical company, Libbs, and the Chemo Group’s biotechnology company, mAbxience, signed a licensing and technology transfer agreement for several biosimilar mAbs developed by mAbxience, including the rituximab biosimilar. A clinical trial sponsored by mAbxience entitled: ‘A Randomized, Double-blind, Phase III Study Comparing Biosimilar Rituximab (RTXM83) Plus CHOP Chemotherapy Versus a Reference Rituximab Plus CHOP (R-CHOP) in Patients With Diffuse Large B-cell Lymphoma (DLBCL) Given as First Line’ was registered under the ClinicalTrials.gov identifier NCT02268045 on 19 September 2014. Libbs and Elea, an Argentina-based company, are among the collaborators that worked towards establishing this protocol. This study is a non-inferiority trial and is currently recruiting participants. Despite this, in Argentina, ANMAT enacted Regulation No. 7060 (dated 2 October 2014), which authorized the commercialization of the biopharmaceutical product Novex (sponsored by Elea), that contains the rituximab biosimilar, RTXM83 [10]. As clinical trials are ongoing, it is evident that this was approved by ANMAT without any clinical data which is contrary to legislation [7–9].
Novex is now being distributed in hospitals and health centres in Argentina to be administered to patients diagnosed with rheumatoid arthritis (RA). As this product has been approved without clinical data, the Argentine Society of Rheumatology has issued a statement suggesting their associates do not administer Novex to patients.
In contrast, a very different situation exists in Brazil. The infliximab biosimilar, CT-P13 (Remsima™), sponsored by Celltrion, received market approval by ANVISA in 29 April 2016. This approval was based on full clinical development, including a phase I clinical trial, known as the PLANETAS trial [11], which compared treatment with CT-P13 to innovator infliximab in individuals with active ankylosing spondylitis. The outcomes, pharmacokinetics and clinical efficacy, including the Assessment in Ankylosing Spondylitis Response Criteria (ASAS) 20 and ASAS 40 responses, were similar in both treatment groups; and the product safety profiles were also comparable up to week 30. After this, a phase III clinical trial, known as the PLANETRA trial [12], was performed, which compared CT-P13 to innovator infliximab in patients with active RA who did not respond well to methotrexate treatment. Equivalence was demonstrated in the American College of Rheumatology 20% (ACR 20) response at week 30. Currently, several trials with proposed biosimilars are in progress and it seems highly likely that approval and marketing of new products will be requested in the near future [13].
Evidence suggests that, although the infliximab biosimilar, CT-P13, was approved in Brazil following full development that demonstrated clinical biosimilarity, interchangeability with the infliximab innovator is not guaranteed. Biosimilars cannot be considered interchangeable or a substitute for their reference product based solely on biosimilarity evidence. It should be left to the clinician’s judgement to choose whether to switch from an originator to a biosimilar. Other paramedical individuals and healthcare payers should not be allowed to change prescriptions or impose the use of biosimilars instead of their originator. Biosimilars should be considered interchangeable if the manufacturer has demonstrated that the drug can produce similar effects to the reference product in any given patient. Moreover, Brazilian medical societies point out that when a biological product is administered to an individual more than once, the risk, in terms of safety or diminished efficacy, of alternating between using the biosimilars and the reference product, is not greater than the risk of using the reference product without such alteration or switch [12]. The best approach should be to conduct a rigorous clinical study to evaluate the possibility of the reference and biosimilar being interchangeable.
The NOR-SWITCH trial (NCT02148640) [14] is a prospective randomized study that aims to examine the ease with which CT-P13 can be interchanged with the infliximab innovator. The authors plan to recruit 500 patients with five different indications for infliximab: RA, plaque psoriasis, ankylosing spondylitis (AS), Crohn’s disease (CD) and ulcerative colitis (UC). All patients will be treated with the infliximab innovator for six months. After this time, half will switch to treatment with CT-P13 and the other half will remain on the infliximab innovator. After 52 weeks, clinical observations will be made by physicians and patients to determine the efficacy of the switch. It is hoped that this will provide robust evidence in support of switching from the reference product to the biosimilar. However, it is generally accepted that clinical trials to assess interchangeability should have crossover or Balaam’s design [15], neither of which are incorporated in this trial; therefore, it cannot be considered an appropriate interchangeability study. No biosimilar should be considered interchangeable until proven by clinical medical evidence [16].
An example of such an interchangeability trial was recently carried out in Italy. Data from the Prospective Observational Cohort Study on patients with inflammatory bowel disease receiving Therapy with BIOsimilars (PROSIT-BIO), obtained from patients with UC and CD, was presented at the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD), VII National Congress in Palermo [17]. With 397 patients (174 UC and 223 CD), this is the largest interchangeability study carried out to date. It demonstrated that comparable efficacy was observed in patients who were switched from the infliximab innovator to the infliximab biosimilar (93 patients), compared to patients receiving a biosimilar who had previously been naïve to anti-TNF (217 patients), and patients receiving a biosimilar who had previously been exposed to one or more biologicals (87 patients) (response rate 95% vs 92% vs 91%, respectively). Safety was also found to be comparable across the patient groups.
Extrapolation of indications is a regulatory decision. CT-P13 is an example of this because it was extrapolated in more than 50 countries including Brazil. This decision is controversial because the biosimilarity of CT-P13 was tested in only two disease models, RA and AS, and then extrapolated to inflammatory bowel disease. The Brazilian regulation of biosimilars, such as RDC 55/2010, has two pathways: individual and comparability. When a biosimilar is only submitted to the individual pathway, it is not possible to extrapolate indications. Submissions must also be made to the comparability pathway in order to enable the extrapolation of indications.
Conversely, Argentinian regulation of biosimilars does not permit extrapolation of indications. The case of the rituximab biosimilar RTXM83, which was approved in Argentina, is challenging. To the best of our knowledge, this product has been approved for all the indications of the rituximab innovator without any clinical data. Therefore, this product is not a true biosimilar because biosimilarity, with respect to the reference product, has not been fully demonstrated.
Based on the evidence, CT-P13 is the only monoclonal antibody marketed in Latin America that can be considered a true biosimilar. Extrapolation is only acceptable when the diseases for which the reference product is used to treat are entirely similar. Extrapolation based on only preclinical studies is unacceptable. Currently, there is no clinical evidence to support that CT-P13 and the reference product are interchangeable.
Conversely, although the proposed rituximab biosimilar (RTXM83) was approved by ANMAT in Argentina, clinical data demonstrating its equivalence with the reference rituximab is necessary before RTXM83 can be considered a true biosimilar.
The interest in biosimilars is growing in Latin America due to a number of factors, including the large proportion of healthcare resources that are used to import high cost branded biologicals. Biosimilars are expected to reduce drug expenditure, assuming that they achieve similar clinical results as the reference product. The need for well-defined pathways and regulations for the review, approval and pharmacovigilance of biosimilars, as well as greater transparency of the actions of governments, are required to facilitate appropriate biosimilar approval and usage. As both Brazil and Argentina have specific regulations concerning the approval of biosimilars, their governments are responsible for guaranteeing the approval of safe and effective biosimilar products.
Disclosure of financial support: The authors declare they have not received any financial incentive to write this paper. This work was not produced with any financial support.
Visit the link www.biossimilares2016.com.br for further information on FLAB.
Competing interests: Adjunct Professor Valderílio Feijó Azevedo is a speaker for AbbVie, AstraZeneca, BMS, Celltrion, Janssen, Novartis, Pfizer, Roche, Sanofi, UCB; and has produced graphic material to AbbVie, Janssen, BMS, Pfizer. He is also a member of the advisory board of AbbVie, AstraZeneca, BMS, Janssen, Merck Serono, Pfizer. Alejandra Babini declares that she is President of the Argentinian Rheumatology Society. She is a consultant, speaker and member of the advisory board of AbbVie and Pfizer. Fabio Vieira Teixeira declares that he is a consultant, speaker and a member of the advisory board of Janssen and Hospira/Pfizer. He is also a consultant and speaker of Ferring and Nestlé. Igor Age Kos and Pablo Matar declare no relevant conflict of interests to participate in this authorship.
Provenance and peer review: Not commissioned; externally peer reviewed.
Adjunct Professor Valderílio Feijó Azevedo1,2, MD, PhD, MBA
Alejandra Babini3,4
Professor Fabio Vieira Teixeira5,6, MSc, MD, PhD
Igor Age Kos1,2
Pablo Matar7
1Federal University of Paraná, Rua Alvaro Alvin, Casa 18 Seminário, Curitiba-Paraná PR 80740–080, Brazil
2Edumed-Health Research and Biotech, 2495 Avenue Bispo Dom José, Seminário
Curitiba-Paraná, Brazil CEP 80440080
3Hospital Italiano Córdoba – Argentina
4Argentinian Society of Rheumatology, Callao 384 Piso 2 Dto 6, CABA, Buenos Aires, Argentina (C1022AAQ)
5Medical Director of Gastrosaude Clinic-Marilia, 62 Sao Paulo Avenue, 17509-190 Marilia, Sao Paulo, Brazil
6Brazilian Study Group on Bowel Inflammatory Diseases
7CONICET – The Argentinian Scientific andTechnical Research Council, Centro Científico Tecnológico Rosario – CONICET
Consejo Nacional de Investigaciones Científicas y Técnicas, Ocampo y Esmeralda, Rosario 2000 – Santa Fe, Argentina
References
1. World Health Organization. Guidelines on evaluation of similar biotherapeutic products (SBPs). 2009 [homepage on the Internet]. [cited 2016 May 30]. Available from: http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22 APRIL2010.pdf
2. Thorpe R, Wadhwa M. Terminology for biosimilars – a confusing minefield. Generics and Biosimilars Initiative Journal (GaBI Journal). 2012; 1(3-4):132-4. doi:10.5639/gabij.2012.0103-4.023
3. European Medicines Agency. Committee for Medical Products for Human Use (CHMP). Guideline on similar biological medicinal products. 30 October 2005 [homepage on the Internet]. [cited 2016 May 30]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517.pdf
4. European Medicines Agency. Assessment report Inflectra. EMA/CHMP/589422/2013. 27 June 2013 [homepage on the Internet]. [cited 2016 May 30]. Available from: http://www.ema.europa.eu/docs/en GB/document library/EPAR – Public assessment report/human/002778/WC500151490
5. European Medicines Agency. Assessment report Remsina. EMA/CHMP/589317/2013. 27 June 2013 [homepage on the Internet]. [cited 2016 May 30]. Available from: http://www.ema.europa.eu/docs/en GB/document library/EPAR – Public assessment report/human/002576/WC500151486.pdf
6. Azevedo VF, Mysler E, álvarez AA, Hughes J, Flores-Murrieta FJ, Ruiz de Castilla EMR. Recommendations for the regulation of biosimilars and their implementation in Latin America. Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3:143-8. doi:10.5639/gabij.2014.0303.032
7. Ministerio de Salud Secretaria de Politicas, Regulacion e Institutos A.N.M.A.T. Disposicion n 7075. 14 October 2011 [homepage on the Internet]. [cited 2016 May 30]. Available from: http://www.anmat.gov.ar/boletin_anmat/octubre_2011/Dispo_7075-11.pdf
8. Ministerio de Salud Secretaria de Politicas, Regulacion e Institutos A.N.M.A.T. Disposicion n 7729. 14 November 2011 [homepage on the Internet]. [cited 2016 May 30]. Available from: http://www.anmat.gov.ar/webanmat/retiros/noviembre/disposicion_7729-2011.pdf
9. Ministerio de Salud Secretaria de Politicas, Regulacion e Institutos A.N.M.A.T. Disposicion n 3397. 12 June 2012 [homepage on the Internet]. [cited 2016 May 30]. Available from: http://www.anmat.gov.ar/webanmat/Legislacion/Medicamentos/Disposicion_3397-2012.pdf
10. Ministerio de Salud Secretaria de Politicas, Regulacion e Institutos A.N.M.A.T. Disposicion n 7060. 2 October 2014 [homepage on the Internet]. [cited 2016 May 30]. http://www.anmat.gov.ar/boletin_anmat/Octubre_2014/Dispo_7060-14.pdf
11. Park W, Hrycaj P, Jeka S, Kovalenko V, Lysenko G, Miranda P, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013;72(10):1605-12.
12. Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72(10):1613-20.
13. Azevedo VF, Meirelles Ede S, Kochen Jde A, Medeiros AC, Miszputen SJ, Teixeira FV, et al. Recommendations on the use of biosimilars by the Brazilian Society of Rheumatology, Brazilian Society of Dermatology, Brazilian Federation of Gastroenterology and Brazilian Study Group on Inflammatory Bowel Disease-Focus on clinical evaluation of monoclonal antibodies and fusion proteins used in the treatment of autoimmune diseases. Autoimmun Rev. 2015;14(9):769-73. doi:10.1016/j.autrev.2015.04.014. Epub 2015 May 1.
14. ClinicalTrials.gov. The NOR-SWITCH Study (NOR-SWITCH) [homepage on the Internet]. [cited 2016 May 30]. Available from: http://clinicaltrials.gov/ct2/show/NCT02148640
15. Chow SC. Biosimilars: design and analysis of follow-on biologics. Chapman and Hall; 2013. Page 19.
16. Fiorino G, Girolomoni G, Lapadula G, Orlando A, Danese S, Olivieri I; SIR, SIDeMaST, and IG-IBD. The use of biosimilars in immune-mediated disease: a joint Italian Society of Rheumatology (SIR), Italian Society of Dermatology (SIDeMaST), and Italian Group of Inflammatory Bowel Disease (IG-IBD) position paper. Autoimmun Rev. 2014 Jul;13(7):751-5. doi:10.1016/j.autrev.2014.02.004. Epub 2014 Mar 19.
17. Fiorino G, et al. 439 The PROSIT-BIO cohort of the IG-IBD: a prospective observational study of patients with inflammatory bowel disease treated with infliximab biosimilars. Gastroenterology. 2016;150(4):S92.
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Author for correspondence: Adjunct Professor Valderilio Feijó Azevedo, MD, PhD, MBA, Rua Alvaro Alvim 224 casa 18, Seminário, Curitiba-Paraná CEP 80440–080, Brazil |
Disclosure of Conflict of Interest Statement is available upon request.
Copyright © 2016 Pro Pharma Communications International
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Source URL: https://gabi-journal.net/new-monoclonal-antibody-biosimilars-approved-in-2015-in-latin-america-position-statement-of-the-latin-american-forum-on-biosimilars-on-biosimilarity-interchangeability-and-extrapolation-of-indications.html
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Abstract: |
Submitted: 4 January 2016; Revised: 27 January 2016; Accepted: 1 February 2016; Published online first: 12 February 2016
On 27 April 2015, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) approved the first biosimilar monoclonal antibody in Brazil. Remsima (CT-P13) is produced by the South Korean biopharmaceutical company Celltrion and will be marketed and distributed in Brazil by Hospira US [1].
This infliximab biosimilar is based on the originator drug Remicade, produced in the US by Janssen Biotech, Inc and distributed in Brazil by the same company [2].
Approval of Remsima was granted for all indications of infliximab based on its full clinical development, including two clinical trials: the phase I clinical trial PLANETAS, and the phase III clinical trial PLANETRA, which compared Remsima to Remicade in patients with active ankylosing spondylitis and rheumatoid arthritis, respectively. Several real life small series have subsequently been reported. So far, Remsima has shown similar efficacy and safety to the infliximab innovator in inflammatory bowel disease (IBD) patients. However, a randomized equivalence trial comparing Remsima with Remicade is still missing.
The approval of Remsima will reduce costs; most of the individuals currently using infliximab can only do so thanks to funding from the Brazilian Government. Approval of the biosimilar is commendable and approved by the medical societies involved. However, scientific, safety and pharmacovigilance issues have arisen and should be carefully addressed and widely discussed for the benefit of patients. Remsima has been approved for use in Brazil based on comparability strictly following the regulations of ANVISA [1]. Remicade, the infliximab originator, was approved in Brazil in 2001 for the treatment of Crohn’s disease. This drug is also approved in our country for other uses: rheumatoid arthritis, psoriasis, ankylosing spondylitis, psoriatic arthritis, fistulizing Crohn’s disease and adult/paediatric ulcerative colitis. In line with the European Medicines Agency (EMA), ANVISA also follows strict international standards for approval of biosimilar drugs [3, 4]. As mentioned, Remsima has been approved by ANVISA based on comparability. To be approved by the Brazilian medicines regulatory agency, the drug has been successfully tested in humans in two clinical studies in rheumatology patients: a phase I clinical study in ankylosing spondylitis and a phase III study in patients with rheumatoid arthritis [5, 6]. The use of Remsima for other diseases listed in the reference drug Remicade package insert was approved based on the concept of extrapolation of indications [1].
In October 2014, the Commission of Biosimilar Drugs of the Brazilian Study Group of Inflammatory Bowel Diseases (GEDIIB) submitted to ANVISA an opinion contrary to the approval of Remsima for individuals with IBD [7–8]. Recently, the Brazilian Societies of Rheumatology, Dermatology and Gastroenterology (represented by GEDIIB) issued the same position [9]. Echoing the opinion of Health Canada, the Canadian agency responsible for the control of drugs, the opinion issued by GEDIIB made it clear that although the biosimilar drug is a positive and welcome measure in the IBD setting, it would be essential to carry out clinical studies with biosimilar products in a population with IBD so that these studies could settle any doubts regarding the efficacy and safety of the long-term use of this biosimilar drug [7, 10]. It is well known in the academic community that only a small number of cases of IBD patients treated with Remsima have been published to date [11]. Moreover, it is known that there is still no prospective randomized study comparing Remsima with the reference drug Remicade.
On the other hand, after the product has been used for over a year in Eastern Europe and Korea, post-marketing studies presented at scientific events have reported good results regarding the efficacy and safety of Remsima used both in adult and paediatric patients with IBD [12–18]. However, a retrospective study conducted in Ireland using a controversial methodology showed a significant increase in hospitalizations, in the use of corticosteroids and in surgery among patients treated with Remsima compared with those who received the reference drug Remicade [19]. As this is to date the only study showing discrepancies in efficacy and safety between the biosimilar and the reference drug, it is vital that we carefully analyse these results and that we remain alert and vigilant. Our patients will certainly be grateful!
The author wishes to thank the English editing support provided by Dr Bea Perks, GaBI Journal Editor, for this manuscript.
Competing interests: The author is a consultant and member of the advisory board of Janssen, Hospira/Pfizer and Ferring.
Provenance and peer review: Not commissioned; internally peer reviewed.
References
1. ANVISA. Primeiro medicamento biológico por comparabilidade é registrado pela Anvisa. 27 April 2015 [homepage on the Internet]. [cited 2016 Jan 27]. Available from: http://s.anvisa.gov.br/wps/s/r/dhM6
2. Jung SK, Lee KH, Jeon JW, Lee JW, Kwon BO, Kim YJ, et al. Physicochemical characterization of Remsima. MAbs. 2014;6(5):1163-77.
3. Beck A, Reichert JM. Approval of the first biosimilar antibodies in Europe: a major landmark for the biopharmaceutical industry. MAbs. 2013;5(5):621-3.
4. Reichert JM. Next generation and biosimilar monoclonal antibodies: essential considerations towards regulatory acceptance in Europe. February 3–4, 2011, Freiburg, Germany. MAbs. 2011;3(3):223-40.
5. Park W, Hrycaj P, Jeka S, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013;72(10):1605-12.
6. Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72(10):1613-20.
7. GEDIIB. Relatório do Grupo de Estudos da Doença Inflamatória Intestinal para ANVISA com respeito ao uso de biossimilar na DII. 2015 [homepage on the Internet]. [cited 2016 Jan 27]. Available from: http://gediib.org.br/?noticias&dado_id=252
8. Teixeira FV, Kotze PG, Damião AO, Miszputen SJ. Biosimilars in inflammatory bowel diseases: an important moment for Brazilian gastroenterologists. Arq Gastroenterol. 2015;52(1):76-80.
9. Azevedo VF, de Souza Meirelles E, Kochen JA, Medeiros AC, Miszputen SJ, Teixeira FV, et al. Recommendations on the use of biosimilars by the Brazilian Society of Rheumatology, Brazilian Society of Dermatology, Brazilian Federation of Gastroenterology and Brazilian Study Group on Inflammatory Bowel Disease–Focus on clinical evaluation of monoclonal antibodies and fusion proteins used in the treatment of autoimmune diseases. Autoimmun Rev. 2015 Sep;14(9):769-73.
10. Health Canada. Health Products and Food Branch, Health Canada. Guidance for sponsors: information and submission requirements for subsequent entry biologics (SEBs) 2010 [homepage on the Internet]. [cited 2016 Jan 27]. Available from: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/brgtherap/applic-demande/guides/seb-pbu/seb-pbu-2010-eng.pdf
11. Kang YS, Moon HH, Lee SE, Lim YJ, Kang HW. clinical experience of the use of CT-P13, a biosimilar to Infliximab in patients with inflammatory bowel disease: a case series. Dig Dis Sci. 2015;60:951-6.
12. Kang HW, Lim YJ, Kim JH, Kang Y. An experience of anti-TNF biosimilar, CT-P13 use: clinical efficacy, safety and interchangeability in inflammatory bowel disease; a pilot study. J Crohn’s Colitis. 2014;8(Suppl 1):S303.
13. Yoon Suk J, Park DI, Kim YH, Seo PJ, Kim JW, Kang HW. Efficacy and safety of infliximab’s biosimilar (REMSIMA®) for IBD. J Crohn’s Colitis. 2015;9(Suppl1):S349-50.
14. Gecse K, Farkas K, Lovasz B, Banai J, Bene L, Gasztonyi B, et al. Biosimilar infliximab in inflammatory bowel diseases: first interim Results from a prospective nationwide observational cohort. J Crohn’s Colitis. 2015;9(Suppl 1):S234-5.
15. Jarzebicka D, Banaszkiewicz A, Plocek A, Sieczkowska J, Gawronska A, Toporowska-Kowalska, et al. Preliminary assessment of efficacy and safety of switching between originator and biosimilar infliximab in paediatric Crohn disease patients. J Crohn’s Colitis. 2015;9(Suppl 1):S224-5.
16. Sieczkowska J, Banaszkiewicz A, Plocek A, Jarzebicka D, Gawronska A, Toporowska-Kowalska E, et al. Assessment of safety and efficacy of biosimilar infliximab in children with Crohn disease: a preliminary report. J Crohn’s Colitis. 2015;9(Suppl 1):S295.
17. Jarzebicka D, Plocek A, Sieczkowska J, Toporowska-Kowalska E, Kierkus J. First observations of the use of biosimilar infliximab for treatment of ulcerative colitis in paediatric population. J Crohn’s Colitis. 2015;9(Suppl 1):S307-8.
18. Molnar T, Farkas K, Rutka M, Bálint A, Nagy F, Bor R, et al. Efficacy of the new infliximab biomarker CTP13 induction therapy on mucosal healing in ulcerative colitis patients. J Crohn’s Colitis. 2015;9(Suppl 1):S382.
19. Murphy C, Sugrue K, Mohamad G, McCarthy J, Buckley M. Biosimilar but not the same. J Crohn’s Colitis. 2015;9(Suppl 1):S331-2.
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Author for correspondence: Professor Fabio V Teixeira, MSc, MD, PhD, Medical Director of Gastrosaude Clinic, 62 Sao Paulo Avenue, 17509-190 Marilia, Sao Paulo, Brazil |
Disclosure of Conflict of Interest Statement is available upon request.
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