Establishing a new marketplace for biologic therapy with biosimilar agents: importance of extrapolation of data

Abstract

Despite their enormous value for our health care system, biopharmaceuticals have become a serious threat to the system itself due to their high cost. Costs may be warranted if the medicine is new and innovative; however, it is no longer an innovation when its patent protection expires. As patents and exclusivities expire on biological drugs, biosimilar products defined as highly similar to reference biologics are being marketed. The goal of biosimilar development is to establish a high degree of biosimilarity, not to reestablish clinical efficacy and safety. Current sophisticated analytical methods allow the detection of even small changes in quality attributes and can therefore enable sensitive monitoring of the batch-to-batch consistency and variability of the manufacturing process. The European Medicines Agency (EMA), US Food and Drug Administration (FDA), and Health Canada have determined that a reduced number of nonclinical and clinical comparative studies can be sufficient for approval with clinical data from the most sensitive indication extrapolated to other indications. Extrapolation of data is a scientifically based principle, guided by specific criteria, and if approved by the EMA, FDA, and/or Health Canada is appropriate. Enablement of extrapolation of data is a core principle of biosimilar development, based on principles of comparability and necessary to fully realize cost savings for these drugs.

Perspectives of Hospital Pharmacists Towards Biosimilar Medicines: A Survey of Polish Pharmacy Practice in General Hospitals

“…They are not identical, but have functional and structural similarities, which should be reflected in their safety, efficacy and clinical properties [ 1 – 3 ]. Biosimilars are new medicines that were first approved by the European Medicines Agency (EMA) in 2006 [ 4 ]. The first biosimilar used in Europe contained somatropin [recombinant human growth hormone (rhGH)] [ 5 ].…”

Biosimilars Are Here: A Hospital Pharmacist's Guide to Educating Health Care Professionals on Biosimilars

“…Such high costs may be expected when the medicine is new and innovative, however it is much harder to sustain when its patent protection expires. 4 It is estimated that $67 billion worth of patents on biologic agents will expire before 2020 ( Table 1). With the expiration of patents and the recent advancements in bioanalytical techniques, the door has been opened for the development of biosimilar versions of originator agents.…”

“…In Canada, the first biosimilar product was approved in 2009. 4,17 Most European Union countries, in cooperation with the World Health Organization (WHO) resources, have developed postmarketing pharmacovigilance programs enabling HCPs to report any unanticipated adverse events (AEs) and/or lack of efficacy for a particular biosimilar. These programs are a series of organized scientific and data collection activities related to the detection, assessment, understanding, prevention, and communication of potential safety concerns with drug products.…”

“…Such high costs may be expected when the medicine is new and innovative, however it is much harder to sustain when its patent protection expires. 4…”