ICs of Enbrel® are being marketed in some countries as biosimilars of etanercept, 8 despite little information being available on the extent of the biochemical differences with respect to innovator etanercept and their potential effects on clinical efficacy and safety. 8 These products may have unintentional structural or chemical differences, and therefore are not biosimilars they are termed intended copies (ICs), biomimics, 9 or non-comparable biotherapeutic products. 5–7 Biologic products that claim biosimilarity, but have not undergone the rigorous characterization and testing as described in World Health Organization (WHO) guidelines, are available in certain countries. The fusion protein is denoted as TNFR:Fc.īiosimilars are biologic drugs designed to be highly similar to the approved reference innovator biologic therapeutic agent they have undergone rigorous analytical, nonclinical, and clinical evaluations to demonstrate similarity to the approved biologic. 4 Each subunit of the dimer comprises the extracellular domain sequence of tumor necrosis factor receptor II (p75 or TNFRII) linked to an analog human Fc portion of a type 1 immunoglobulin G. 3 Etanercept is a technically complex protein expressed by modified Chinese hamster ovary (CHO) cells in culture, and produced as a covalent dimer. Although the consequences of these differences are largely unknown, the potential for unanticipated clinical outcomes should not be overlooked.Įtanercept (Enbrel®) is a recombinant human fusion protein used in the treatment of rheumatoid arthritis (RA) and other autoimmune diseases, 1 including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, 2 and juvenile idiopathic arthritis (JIA including the JIA categories extended oligoarthritis, enthesitis-related arthritis, and psoriatic arthritis). While a number of quality attributes of the IC lots tested met the release specifications for Enbrel®, none fell within these limits across all methods performed, and there were no IC lots that satisfied the criteria typically applied by the innovator to support comparability with Enbrel®. Biologic products that would not meet the minimum World Health Organization's standard for evaluation of similar biotherapeutic products are available in some countries in some cases relevant data to assess biosimilarity and appropriate regulatory approval pathways are lacking.īatches of seven intended copy (IC) products for etanercept (Enbrel®) were subjected to a subset of test methods used in the routine release and heightened characterization of Enbrel®, to determine key attributes of identity, quality, purity, strength, and activity. Regulatory authorities have outlined the structural characterization and clinical assessments necessary to establish biosimilarity of a new biotherapeutic product with the innovator biologic drug.

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It is not recommended for use in patients at an increased risk of osteosarcoma. It is generally used in patients at a high risk of fractures. Terifrac Pen is a recombinant form of parathyroid hormone used for the treatment of osteoporosis.

Intacept injection 25 mg