Patent expiry dates for biologicals: 2016 update

Editor, GaBI Journal

doi:10.5639/gabij.2017.0601.006

Cited by 10 publications

(4 citation statements)

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“…As a result of the pioneering role in regulation of biosimilar medicines, the number of authorized biosimilars in Europe has increased rapidly compared to the number of biosimilars currently approved for the US market. To date, the FDA authorized 19 biosimilar products on the US market under the Public Health Service act (PHS) [16]. The EMA, in contrast, has authorized 56 biosimilar products for use throughout Europe via the European Union-wide authorization procedure (Table 1).…”

Section: Introductionmentioning

confidence: 99%

Glycosylation of biosimilars: Recent advances in analytical characterization and clinical implications

Duivelshof

Jiskoot

Beck

et al. 2019

Analytica Chimica Acta

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License: Article 25fa pilot End User Agreement This publication is distributed under the terms of Article 25fa of the Dutch Copyright Act (Auteurswet) with explicit consent by the author. Dutch law entitles the maker of a short scientific work funded either wholly or partially by Dutch public funds to make that work publicly available for no consideration following a reasonable period of time after the work was first published, provided that clear reference is made to the source of the first publication of the work. This publication is distributed under The Association of Universities in the Netherlands (VSNU) 'Article 25fa implementation' pilot project. In this pilot research outputs of researchers employed by Dutch Universities that comply with the legal requirements of Article 25fa of the Dutch Copyright Act are distributed online and free of cost or other barriers in institutional repositories. Research outputs are distributed six months after their first online publication in the original published version and with proper attribution to the source of the original publication. You are permitted to download and use the publication for personal purposes. All rights remain with the author(s) and/or copyrights owner(s) of this work. Any use of the publication other than authorised under this licence or copyright law is prohibited. If you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons.

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Section: Introductionmentioning

confidence: 99%

Glycosylation of biosimilars: Recent advances in analytical characterization and clinical implications

Duivelshof

Jiskoot

Beck

et al. 2019

Analytica Chimica Acta

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“…The patents of many best-selling biotherapeutic products have already expired or will soon reach their expiry date. For example, the patent on the breast cancer drug Herceptin, a monoclonal antibody with international nonproprietary name trastuzumab, expired in July 2014 in the European Union and will expire in June 2019 in the United States of America 1 . Currently, several companies worldwide have developed biosimilar versions of trastuzumab.…”

Section: Introductionmentioning

confidence: 99%

Regulatory evaluation of biosimilars throughout their product life-cycle

Kang

Knežević

2018

Bull. World Health Organ.

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The World Health Assembly in 2014 adopted a resolution that recognized the importance of increasing access to biotherapeutic products, of improving their affordability and of ensuring their quality, safety and efficacy. Biosimilars are biotherapeutic products similar to already licensed reference products and are usually developed after patents on the original products have expired. Their introduction into the market is likely to reduce the costs of medicines substantially, thereby improving the availability of treatment for patients. However, there are barriers to market access for biosimilars. This article discusses the factors that give rise to these barriers and explains the importance of regulatory oversight throughout the product life-cycle of biosimilars. The paper also describes the role regulators can play in increasing confidence in biosimilars use by: (i) establishing regulatory oversight of biosimilars throughout their life-cycle, from development to post-licensing oversight, and ensuring that only high-quality, safe and efficacious biosimilars are available on the market; (ii) ensuring regulatory authorities have adequate capacity to assess and monitor the quality, safety and efficacy of biosimilars throughout their life-cycle; and (iii) monitoring the use of biosimilars in public health systems in collaboration with other stakeholders.

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“…Since, in comparison to cetuximab, more recent data show at least equivalence if not superiority in terms of effectiveness in the treatment of CRC with a more favorable side effect profile [35], it is not surprising that the industry is interested in developing these biosimilars [36]. The EU patent expires in 2018, the US patent in 2020 [31]. …”

Section: Beyond the Blockbusters - Monoclonal Antibody Biosimilars Inmentioning

confidence: 99%

“…It is used for the treatment of metastatic CRC and squamous cell carcinoma of the head and neck in conjunction with radiation and chemotherapy [30]. The US patents for the drug expired in 2016 and EU patents expired in 2014 [31]. Several companies, however, are in the process of developing cetuximab biosimilars [32].…”

Section: Beyond the Blockbusters - Monoclonal Antibody Biosimilars Inmentioning

confidence: 99%

What Does the Pipeline Promise about Upcoming Biosimilar Antibodies in Oncology?

Busse

Lüftner²

2019

Breast Care

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The introduction of biosimilars of biological agents for which the patents and exclusivity periods have expired is an attractive way of reducing healthcare spending through price competition with the reference product. In oncology, biosimilars of growth factors for supportive therapy were the pioneers; now, monoclonal antibody biosimilars are conquering the market. In Europe, this is currently limited to biosimilars of the monoclonal antibodies trastuzumab and rituximab. However, the pipeline is full and several monoclonal antibody biosimilars in oncology are now in late-stage development. We are expecting not only more biosimilar versions of the top 3 blockbuster monoclonal antibodies, trastuzumab, rituximab and bevacizumab, to enter the market; as patent expiration of multiple other cancer biologicals will occur in the next few years, the biosimilar landscape will become much more diversified. Several biosimilars of monoclonal antibodies used in targeted therapy such as cetuximab, pertuzumab, or denosumab are in early development.

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Patent expiry dates for biologicals: 2016 update

Cited by 10 publications

References 0 publications

Glycosylation of biosimilars: Recent advances in analytical characterization and clinical implications

Glycosylation of biosimilars: Recent advances in analytical characterization and clinical implications

Regulatory evaluation of biosimilars throughout their product life-cycle

What Does the Pipeline Promise about Upcoming Biosimilar Antibodies in Oncology?

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