IntroductionBiosimilars are biological medicines that are highly similar to the originator product. Availability of biosimilars for biological products which go off patent is expected to decrease per‐patient treatment costs and provide greater patient access, contributing to the reduction in disability, morbidity and mortality associated with inflammatory diseases.There are well‐defined regulatory guidelines in the United States (US) and the European Union (EU) on scientific considerations for demonstration of biosimilarity; the EU guidelines are considered the gold standard for authorization of biosimilar medicines. From the perspective of interchangeability between an originator and a biosimilar, the US Food and Drug Administration (US FDA) has recently issued a draft guidance on considerations in demonstrating interchangeability of a biosimilar with a reference product (originator). In the EU, there is no separate designation of interchangeability, rather biosimilars can be viewed as interchangeable, and the decision is left to individual member states for framing the rules. Apart from the regulatory perspective, the evaluation of the effect of multiple switches between originator and biosimilar with regard to efficacy, safety and immunogenicity is of great interest to physicians and patients.GP2015 (Erelzi™) is an etanercept biosimilar approved by the US FDA for treatment of rheumatoid arthritis and polyarticular juvenile
Journal of the European Academy of Dermatology & Venereology – Wiley
Published: Jan 1, 2018
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