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      Approval of the first biosimilar antibodies in Europe : A major landmark for the biopharmaceutical industry

      editorial

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          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          In a defining moment for the European Medicines Agency (EMA) and the biopharmaceutical industry, on June 27, 2013 EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for two biosimilar infliximab products (Celltrion’s Remsima® and Hospira’s Inflectra®), and recommended that they be approved for marketing in the European Union (EU). The European Commission’s decision on an application is typically issued 67 d after an opinion is provided; thus, decisions are expected in early September 2013. If approved, the products will comprise the first biosimilar antibody made available to patients in a highly regulated market, although launch may be delayed due to an extension of the reference product’s (Remicade®) patent in the EU.

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          Strategies and challenges for the next generation of therapeutic antibodies.

          Alain Beck, Thierry Wurch, Christian Bailly … (2010)
          Antibodies and related products are the fastest growing class of therapeutic agents. By analysing the regulatory approvals of IgG-based biotherapeutic agents in the past 10 years, we can gain insights into the successful strategies used by pharmaceutical companies so far to bring innovative drugs to the market. Many challenges will have to be faced in the next decade to bring more efficient and affordable antibody-based drugs to the clinic. Here, we discuss strategies to select the best therapeutic antigen targets, to optimize the structure of IgG antibodies and to design related or new structures with additional functions.
          Article 0 comments Cited 217 times – based on 0 reviews     Review now
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            Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars.

            Jeffrey R. Mazzeo, John Engen, Ross Berkowitz … (2012)
            Biologics such as monoclonal antibodies are much more complex than small-molecule drugs, which raises challenging questions for the development and regulatory evaluation of follow-on versions of such biopharmaceutical products (also known as biosimilars) and their clinical use once patent protection for the pioneering biologic has expired. With the recent introduction of regulatory pathways for follow-on versions of complex biologics, the role of analytical technologies in comparing biosimilars with the corresponding reference product is attracting substantial interest in establishing the development requirements for biosimilars. Here, we discuss the current state of the art in analytical technologies to assess three characteristics of protein biopharmaceuticals that regulatory authorities have identified as being important in development strategies for biosimilars: post-translational modifications, three-dimensional structures and protein aggregation.
            Article 0 comments Cited 120 times – based on 0 reviews     Review now
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              Biosimilars: what clinicians should know.

              Meenu Wadhwa, Martina Weise, Niklas Ekman … (2012)
              Biosimilar medicinal products (biosimilars) have become a reality in the European Union and will soon be available in the United States. Despite an established legal pathway for biosimilars in the European Union since 2005 and increasing and detailed regulatory guidance on data requirements for their development and licensing, many clinicians, particularly oncologists, are reluctant to consider biosimilars as a treatment option for their patients. Major concerns voiced about biosimilars relate to their pharmaceutical quality, safety (especially immunogenicity), efficacy (particularly in extrapolated indications), and interchangeability with the originator product. In this article, the members and experts of the Working Party on Similar Biologic Medicinal Products of the European Medicines Agency (EMA) address these issues. A clear understanding of the scientific principles of the biosimilar concept and access to unbiased information on licensed biosimilars are important for physicians to make informed and appropriate treatment choices for their patients. This will become even more important with the advent of biosimilar monoclonal antibodies. The issues also highlight the need for improved communication between physicians, learned societies, and regulators.
              Article 0 comments Cited 83 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): MAbs
                Journal ID (iso-abbrev): MAbs
                Journal ID (publisher-id): MABS
                Title: mAbs
                Publisher: Landes Bioscience
                ISSN (Print): 1942-0862
                ISSN (Electronic): 1942-0870
                Publication date (Print): 01 September 2013
                Publication date (Electronic): 24 July 2013
                Publication date PMC-release: 24 July 2013
                Volume: 5
                Issue: 5
                Pages: 621-623
                Affiliations
                [1 ]Centre d’Immunologie Pierre Fabre; Saint-Julien-en-Genevois, France
                [2 ]Reichert Biotechnology Consulting LLC; Framingham, MA USA
                Author notes
                [* ]Correspondence to: Alain Beck, Email: alain.beck@ 123456pierre-fabre.com and Janice M. Reichert, Email: reichert.biotechconsulting@ 123456gmail.com
                Article
                Publisher ID: 2013MABSED0505 Publisher Item ID: 25864
                DOI: 10.4161/mabs.25864
                PMC ID: 3851211
                PubMed ID: 23924791
                SO-VID: 6c707f08-5d9c-4e8f-95d7-1c60476263f4
                Copyright © Copyright © 2013 Landes Bioscience
                License:

                This is an open-access article licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License. The article may be redistributed, reproduced, and reused for non-commercial purposes, provided the original source is properly cited.

                History
                Date received : 23 July 2013
                Date accepted : 23 July 2013
                Categories
                Subject: Editorial

                ScienceOpen disciplines: Immunology
                Keywords: adalimumab,antibody,biobetters,biosimilars,bevacizumab,cetuximab,etanercept,fc-fusion protein,follow-on biologicals,infliximab,mass spectrometry,rituximab,trastuzumab
                Data availability:
                ScienceOpen disciplines: Immunology
                Keywords: adalimumab, antibody, biobetters, biosimilars, bevacizumab, cetuximab, etanercept, fc-fusion protein, follow-on biologicals, infliximab, mass spectrometry, rituximab, trastuzumab

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