Current Issue : July - September Volume : 2016 Issue Number : 3 Articles : 4 Articles
Background: CT-P13 (RemsimaÃ?®, InflectraÃ?®) is a biosimilar of the infliximab reference product (RP; RemicadeÃ?®). The\naim of this study was to compare the 54-week efficacy, immunogenicity, safety, pharmacokinetics (PK) and\npharmacodynamics (PD) of CT-P13 and RP in patients with active rheumatoid arthritis (RA).\nMethods: In this multinational phase III double-blind study, patients with active RA and an inadequate response to\nmethotrexate (MTX) were randomized (1:1) to receive CT-P13 (3 mg/kg) or RP (3 mg/kg) at weeks 0, 2, 6 and then\nevery 8 weeks to week 54 in combination with MTX (12.5ââ?¬â??25 mg/week). Efficacy endpoints included American\nCollege of Rheumatology (ACR)20, ACR50 and ACR70 response rates, Disease Activity Score in 28 joints (DAS28),\nSimplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), European League Against Rheumatism\n(EULAR) response rates, patient-reported outcomes and joint damage progression. Immunogenicity, safety and PK/\nPD outcomes were also assessed.\nResults: Of 606 randomized patients, 455 (CT-P13 233, RP 222) were treated up to week 54. At week 54, ACR20\nresponse rate was highly similar between groups (CT-P13 74.7 %, RP 71.3 %). ACR50 and ACR70 response rates were\nalso comparable between groups (CT-P13 43.6 % and 21.3 %, respectively; RP 43.1 % and 19.9 %, respectively).\nDAS28, SDAI and CDAI decreased from baseline to week 54 to a similar extent with CT-P13 and RP. Radiographic\nprogression measured by Sharp scores as modified by van der Heijde was also comparable. With both treatments,\npatient assessments of pain, disease activity and physical ability, as well as mean scores on the Medical Outcomes\nStudy Short Form Health Survey (SF-36), improved markedly at week 14 and remained stable thereafter up to week\n54. The proportion of patients positive for antidrug antibodies at week 54 was similar between the two groups: 41.1\n% and 36.0 % with CT-P13 and RP, respectively. CT-P13 was well tolerated and had a similar safety profile to RP. PK/\nPD results were also comparable between CT-P13 and RP.\nConclusions: CT-P13 and RP were comparable in terms of efficacy (including radiographic progression),\nimmunogenicity and PK/PD up to week 54. The safety profile of CT-P13 was also similar to that of RP.\n(Continued on next page)...
The development of biological products has experienced continuous growth over the past three decades. The expiration of patent\nprotection for many biological medicines has led to the development of biosimilars in many countries around the world. This paper\nreviews the literature on biosimilar drugs and covers their therapeutic status, clinical trials, approved biosimilars, and regulatory\nguidelines in Japan, South Korea, and Malaysia. The literature suggests that biosimilars are comparable but not identical to the\nreference product. They are not a generic version of an innovative product and do not ensure therapeutic equivalence. Biosimilars\npresent more challenges than conventional generics and their marketing approval is also much more complicated. Guidelines for\nbiosimilars were published in Japan in July 2009 by the Ministry of Health, Labour and Welfare (MHLW), in South Korea in March\n2009 by the Ministry of Food and Drug Safety (MFDS), and in Malaysia in July 2008 by the National Pharmaceutical Control\nBureau (NPCB)....
Background\nSince 2007 biosimilars of erythropoiesis-stimulating agents (ESAs) are available on the Italian\nmarket. Very limited post-marketing data exist on the comparative effectiveness of biosimilar\nand originator ESAs.\nAim\nThis population-based study was aimed to compare the effects of biosimilars, reference\nproduct and other ESAs still covered by patent on hemoglobinemia in chronic kidney disease\n(CKD) and cancer patients in a Local Health Unit (LHU) from Northern Italy.\nMethods\nA retrospective cohort study was conducted during the years 2009ââ?¬â??2014 using data from\nTreviso LHU administrative database. Incident ESA users (no ESA dispensing within 6\nmonths prior to treatment start, i.e. index date (ID)) with at least one hemoglobin measurement\nwithin one month prior to ID (baseline Hb value) and another measurement between\n2nd and 3rd month after ID (follow-up Hb value) were identified. The strength of the consumption\n(as total number of defined daily dose (DDD) dispensed during the follow-up divided by days of follow-up) and the difference between follow-up and baseline Hb values\n[delta Hb (Ã?â?Hb)] were evaluated. Based on Hb changes, ESA users were classified as nonresponders\n(Ã?â?Hb0 g/dl), responders (0<Ã?â?Hb2 g/dl), and highly responders (Ã?â?Hb>2 g/\ndl). A multivariate ordinal logistic regression model to identify predictors for responsiveness\nto treatment was performed. All analyses were stratified by indication for use and type of\ndispensed ESA at ID.\nResults\nOverall, 1,003 incident ESA users (reference product: 252, 25.1%; other ESAs covered by\npatent: 303, 30.2%; biosimilars: 448, 44.7%) with CKD or cancer were eligible for the study.\nNo statistically significant difference in the amount of dose dispensed during the follow-up\namong biosimilars, reference product and other ESAs covered by patent was found in both\nCKD and cancer. After three months from treatment start, all ESAs increased Hb values\non average by 2g/dl. No differences in Ã?â?Hb as well as in frequency of non-responders,\nresponders and highly responders among different types of ESAs were observed in both\nindications of use. Overall, around 15ââ?¬â??20% of ESA users were non-responders. Strength of\ntreatment, but no type of dispensed ESAs was found to be predictor of responsiveness to\ntreatment.\nConclusions\nNo difference on the effects on hemoglobinemia among users of either biosimilars or reference\nproduct or ESAs covered by patent was observed in a general population from Northern\nItaly, despite a comparable dispensed dose of the different ESAs during the first three\nmonths of treatment....
Background: In 2014, six of the top ten blockbuster medicines were monoclonal\nantibodies. This multibillion-dollar market with expiring patents is the main driver for\nthe development of biosimilar mAbs. With the ever-increasing cost of healthcare and\nthe economic pressure to reduce or sustain healthcare expenses, biosimilars could be\ninstrumental in reducing costs for medication and increasing patient access to treatment.\nObjectives: The aim of this study is to identify and describe the barriers to market\naccess of biosimilar mAbs in the European Union and to analyze how these barriers\ncould be overcome.\nMethods: A narrative literature review was carried out using the databases PubMed,\nEmbase, and EconLit. Studies were published in English or Dutch. Additionally, the\nreference list of the articles was checked for relevant studies. Articles and conference\npapers known to the authors were included as well. Articles were also identified by\nsearching on the website of the Generics and Biosimilars Initiative (GaBI) journal.\nResults: Six barriers were identified based on available literature: The manufacturing\nprocess, the regulatory process, intellectual property rights, lack of incentive, the\nimpossibility of substitution, and the innovator�s reach. These six barriers are\npresented as a possible framework to study the market access of biosimilar mAbs.\nBased on the literature search, recommendations can be made to overcome these\nbarriers: (i) invest initially in advanced production processes with the help of singleuse\ntechnology, experience or outsourcing (ii) gain experience with the regulatory\nprocess and establish alignment between stakeholders (iii) limit patent litigation,\neliminate evergreening benefits, build out further the unitary patent and unified\npatent litigation system within the EU (iv) create demand-side policies, disseminate\nobjective information (v) change attitude toward biosimilar switching/substitution,\nstarting with physician, and patient education (vi) differentiate the biosimilar by\nservice offerings, use an appropriate comparator in cost-effectiveness analyses. Conclusions: Barriers to the market access of biosimilar mAbs could be reduced when\nmore transparency and communication/education is used in all steps toward market\naccess in order to increase the trust in biosimilar mAbs by all stakeholders. Only then\nbiosimilar mAbs will be able to fully capture their cost saving potential....
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