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 clinical outcome cannot be overstated, these efficacious treatments for rheumatic diseases are not without a high cost.Biological agents are expensive and rheumatological diseases are common. The patent and regulatory data protection periods for the first and second waves of biological agents based on recombinant proteins have begun to expire, leaving open the potential for development and regulatory approval of one or more "generic" versions of these biological therapies, termed "biosimilars" or "BSs"in Europe (the term we shall use from henceforth), "subsequent entry biologics" in Canada, or "follow-on-biologics" in US. We aimed to review the critical topics of efficacy, safety and regulatory approach of upcoming biosimilars.

A phase 1, randomized, open-label, single-dose study to assess the relative bioavailability of a subcutaneous dose of FKB327 when administered using a prefilled syringe, a prefilled auto-injector, or a vial with disposable syringe in healthy subjects

“…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].…”

Biosimilars for Immune-Mediated Chronic Diseases in Primary Care: What a Practicing Physician Needs to Know

“…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.…”

“…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.…”

Biosimilar medicines uptake: The role of the clinical pharmacist

“…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.…”