Results 21 to 30 of about 16,304 (256)
For a drug to be defined as a biosimilar, it should be fairly similar to the previously approved original or reference product. The minor variances in its inactive ingredients should not pose clinically significant differences from the reference product in terms of safety and efficacy potency.
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Background ABP 501 was evaluated in a phase 3 single-arm, open-label extension (OLE) study to collect additional safety and efficacy data in patients with rheumatoid arthritis (RA).
Stanley Cohen+7 more
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Policies for biosimilar uptake in Europe: An overview. [PDF]
Across European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe.The aim of this article is to provide an overview of different initiatives and policies that ...
Evelien Moorkens+33 more
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The aim of this study is to evaluate the effect of the introduction of biosimilars in Bulgaria on the prices and utilization of biologic disease modifying antirheumatic drugs (bDMARD).
Konstantin Tachkov+3 more
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The structure-function relationship of disulfide bonds in etanercept
Etanercept is a TNFα receptor Fc fusion protein used for the treatment of rheumatic disease and psoriasis. Physicochemical and functional investigation of process fractions during development of the etanercept biosimilar GP2015 (Erelzi®) revealed a ...
William C. Lamanna+10 more
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Background: Biosimilars can improve patient access to biological medicines. Although biosimilars have been shown to be equally effective and safe, some patients remain reluctant to transition to biosimilars.
Chiara Gasteiger+2 more
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Over the last decade the availability of biological drugs for the treatment of psoriasis vulgaris, psoriatic arthritis and many other inflammatory diseases has revolutionized the treatment of these diseases around the world. Due to the high cost of therapy, the search has started for biosimilars.
Zygmunt Adamski+4 more
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Biosimilar: what it is not [PDF]
A biosimilar is a high quality biological medicine shown to be in essence the same as an original product. The European Medicines Agency (EMA) paved the way in the regulatory arena by creating a safeguarding framework for the development of biosimilars.
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Biosimilar-to-Biosimilar Switching: What is the Rationale and Current Experience? [PDF]
Over time, clinicians have become increasingly comfortable embracing the prescription of biosimilars-highly similar versions of innovator or reference biological agents-for their patients with inflammatory diseases. Although a switch from a reference product to a licensed biosimilar version (or vice versa) is a medical decision robustly supported by ...
Mysler, Eduardo+7 more
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Physician awareness and perceptions towards biosimilars are important factors in their adoption to clinical practice. Our objectives were to assess levels of knowledge and attitudes towards biosimilars and key policies on their use among Russian ...
Dmitry Karateev, Natalia Belokoneva
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