Review of biologics, biosimilars, and intended copies in rheumatology, and current practice in Iraq

Abstract

Biologic therapies are an important option in the treatment of patients with rheumatic disease. As the development of potential biosimilars increases, many countries are following the guidelines developed by the WHO, European Medicines Agency, or US Food and Drug Administration to create country-specific regulations for the review and approval of these products. Iraq does not yet have such regulations, and this presents a potential safety concern for patients. The analytical, nonclinical, and clinical data requirements for approval of a potential biosimilar are specific and scientifically rigorous. In some countries, products are available that have not met the stringent criteria for biosimilars; they are usually referred to as “intended copies”. Frequently, the available data are not sufficient to demonstrate that they are similar in efficacy and safety to the reference product. Thus, safety issues may arise once the product is in use, as was the case with Kikuzubam, an intended copy of rituximab that was withdrawn from the market in Mexico following reports of severe adverse reactions. It is important to implement scientific, evidence-based guidelines for the review, approval, therapeutic use, and monitoring of biosimilars, and to provide training on this topic to healthcare professionals and patients. In this review, we discuss issues related to the use and regulation of biosimilars, and the differences between biosimilars and intended copies. We also provide suggestions for including biosimilars as a treatment option in Iraq.

Current treatments for biofilm‐associated periprosthetic joint infection and new potential strategies

“…Polyclonal and monoclonal antibodies have come to the forefront initially to treat rheumatologic diseases. Recently, drug companies have begun focusing on developing biologics for many nonrheumatologic diseases 87,88 . Effectiveness in protecting against biofilm infections using various monoclonal/polyclonal antibodies has been shown in vitro and in animal models but very few have seen success as a clinical treatment 89 .…”

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“… Biosimilar can be defined as the drugs that are similar to an approved biologics with regard to its quality, safety, and efficacy. These biosimilars should be demonstrated through the comparison of quality and biological activity as well as nonclinical and clinical study data 5 . Similar but not the same.…”

Cost-effectiveness Analysis of Reference Infliximab (Remicade) Compared to its Biosimilar (Remsima) in Iraqi Patients with Rheumatoid Arthritis (Conference Paper )#

“…One of the main causes for the recent lack of important medications in Iraq has been insufficient funding granted to KIMADIA (18) . In order for biosimilars to be successfully included in treatment regimens in Iraq, healthcare professionals and government decision-makers must possess an extensive understanding of biosimilars (19) .…”