2015
DOI: 10.1016/j.intimp.2015.04.022
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Biosimilar vs biological agents in rheumatology: When are biosimilar agents similar enough?

Abstract: With the introduction of biological agents, over the last two decades treatment prospects in many medical fields includingRheumatology have experienced an exciting revolution. The advent of biological therapy for specifically rheumatic diseases has provided more effective control of both the underlying disease, and sustained amelioration of disease activity, compared to the pre-biological era when only anti-inflammatory and immunosuppressant drugs were available. Although the importance of potential improved c… Show more

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Cited by 7 publications
(4 citation statements)
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“…Biosimilar agents are not generic forms of reference biological products. Unlike generic drugs, which are identical copies of the reference drug with the same pharmacologic effects and safety profile, biosimilars are products highly similar to the reference biologic agent but not identical [5]. Thus, whereas generic drugs can be approved on the basis of bioequivalence (BE) to the reference drug, the same is not true for the approval of biosimilars [6].…”
Section: Introductionmentioning
confidence: 99%
“…Biosimilar agents are not generic forms of reference biological products. Unlike generic drugs, which are identical copies of the reference drug with the same pharmacologic effects and safety profile, biosimilars are products highly similar to the reference biologic agent but not identical [5]. Thus, whereas generic drugs can be approved on the basis of bioequivalence (BE) to the reference drug, the same is not true for the approval of biosimilars [6].…”
Section: Introductionmentioning
confidence: 99%
“…48 Since the inception of the Biologics Price Competition and Innovation Act, interest has grown in the development of biosimilars. 8 This increased competition resulting from biosimilars is expected to drive down prices. 63 Based on estimates from the US National Health and Wellness survey of patients with moderate to severe psoriasis who were commercially insured, approximately 20% received a biologic therapy, suggesting underuse of these agents in this population.…”
Section: Costmentioning
confidence: 99%
“…2 Since then, biologics have revolutionized not only the treatment of rheumatoid arthritis, 3 but also of moderate to severe psoriasis, 4 inflammatory bowel disease 5,6 and other conditions. [7][8][9] Whereas conventional disease-modifying drugs have improved the prognosis for patients, biologics have further enhanced symptom management and slowed disease progression for those with challenging conditions, owing to their high efficacy, speed of onset and tolerability profile. 10,11 However, these agents come with a high cost; biosimilars may help reduce that cost.…”
Section: Introductionmentioning
confidence: 99%
“…anemia of chronic renal failure, 3 endocrine disorders, 3 uveitis, 3 ankylosing spondylitis, 3 , 4 inflammatory bowel disease, 3. , 4 , 5 , 6 , 7 psoriasis, 3 , 4 , 8 rheumatoid arthritis, 3 , 4 , 9 , 10 among others. 3 The high cost of these biological medicines and the recent expiration of patents of many of them has spurred manufacturers to explore the production of biosimilars.…”
Section: Introductionmentioning
confidence: 99%