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38 Newest Publications about the topic biosimilars

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Enhanced Expression of a Biosimilar Monoclonal Antibody with a Novel NS0 Platform

02-Jan-2018 | Darryl Sampey, Pascal Courville, David Acree, Jeffrey Hausfeld, William E. Bentley, Biotechnology Progress, 2018

Abstract The precise product quality and lower cost of goods demands of the growing biosimilars industry are driving biomanufacturing innovation. Biosimilar cell lines that produce complex glycoproteins such as monoclonal antibodies must be both highly productive and express a product with ...

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The Supreme Court's interpretation of the biosimilars statute and the value of certainty

11-Oct-2017 | Irena Royzman; Nathan Monroe-Yavneh, Nature Biotechnology, 2017

Nature Biotechnology 35, 916 (2017). doi:10.1038/nbt.3977 Authors: Irena Royzman & Nathan Monroe-Yavneh The Supreme Court's decision in Sandoz v. Amgen introduces uncertainty into provisions that many viewed as necessary and enforceable, but its impact may ultimately be ...

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The Supreme Court's interpretation of the biosimilars statute and the value of certainty

11-Oct-2017 | Irena Royzman; Nathan Monroe-Yavneh, Nature Biotechnology, 2017

Nature Biotechnology 35, 916 (2017). doi:10.1038/nbt.3977 Authors: Irena Royzman & Nathan Monroe-Yavneh The Supreme Court's decision in Sandoz v. Amgen introduces uncertainty into provisions that many viewed as necessary and enforceable, but its impact may ultimately be ...

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Biosimilars: Key regulatory considerations and similarity assessment tools

26-Aug-2017 | Carol F. Kirchhoff, Xiao‐Zhuo Michelle Wang, Hugh D. Conlon, Scott Anderson, Anne M. Ryan, Arindam Bose, Biotechnology and Bioengineering, 2017

Abstract A biosimilar drug is defined in the US Food and Drug Administration (FDA) guidance document as a biopharmaceutical that is highly similar to an already licensed biologic product (referred to as the reference product) notwithstanding minor differences in clinically inactive components ...

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How to select a nanosimilar

17-Jul-2017 | Alain Astier, Amy Barton Pai, Marco Bissig, Daan J.A. Crommelin, Beat Flühmann, Jean‐Daniel Hecq, Josefien Knoeff, H ..., Annals of the New York Academy of Sciences, 2017

Nanomedicines in the class of nonbiological complex drugs (NBCDs) are becoming increasingly available. Up to 23 nanomedicines have been approved, and approximately 50 are in clinical development. Meanwhile, the first nanosimilars have entered the market through the generic approval pathway, but ...

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Assessing gastroenterologist and patient acceptance of biosimilars in ulcerative colitis and Crohn's disease across Germany

14-Apr-2017 | Emma Sullivan; James Piercy; John Waller; Christopher M. Black; Sumesh Kachroo, PLoS ONE, 2017

by Emma Sullivan, James Piercy, John Waller, Christopher M. Black, Sumesh Kachroo Objectives This study examined gastroenterologists’ motivation for prescribing biosimilars, assessed their treatment preferences in relation to prescribing behaviour, and explored patient attitudes to ...

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Pharmaceuticals, Vol. 10, Pages 19: Barriers to the Access of Bevacizumab in Patients with Solid Tumors and the Potential Impact of Biosimilars: A Physician Survey

28-Jan-2017 | Monk, Bradley J.; Lammers, Philip E.; Cartwright, Thomas ; Jacobs, Ira, Pharmaceuticals, 2017

Access to bevacizumab, an important component of oncology treatment regimens, may be limited. This survey of oncologists in the US (n = 150), Europe (n = 230), and emerging markets (EM: Brazil, Mexico, and Turkey; n = 130) examined use of and barriers to accessing bevacizumab as treatment of ...

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Predictive glycoengineering of biosimilars using a Markov chain glycosylation model

17-Nov-2016 | Philipp N. Spahn, Anders H. Hansen, Stefan Kol, Bjørn G. Voldborg, Nathan E. Lewis, Biotechnology Journal, 2016

Abstract Biosimilar drugs must closely resemble the pharmacological attributes of innovator products to ensure safetyand efficacy to obtain regulatory approval. Glycosylation is one critical quality attribute that must be matched, but it is inherently difficult to control due to the complexity ...

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Position Paper from the Portuguese Association of Hospital Pharmacists for biosimilar therapeutic antibodies

11-Nov-2016 | J. Goncalves, P. Matos de Brito, A. Batista, J. Feio, F. Machado, J. Aperta, I. Ascensão, V. Pires, C. Oliveira, R. ..., Journal of Clinical Pharmacy and Therapeutics, 2016

Summary What is known and Objective Biopharmaceuticals are an important class of drugs for the treatment of autoimmune/inflammatory and oncologic diseases. With patent expiries, biotechnological manufacturers can now develop biosimilar drugs. Due to timeliness of introducing new and more ...

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Clinical trials for authorised biosimilars in the European Union: A systematic review

01-Sep-2016 | J. Mielke, B. Jilma, F. Koenig, B. Jones, British Journal of Clinical Pharmacology, 2016

Aim In 2006, Omnitrope (by Sandoz) was the first approved biosimilar in Europe. To date, 21 biosimilars for seven different biologics are on the market. In this paper, the clinical trials undertaken to get market authorisation are compared. Methods We summarize the findings of a ...

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