- 70 pages
- English
- ePUB (mobile friendly)
- Available on iOS & Android
eBook - ePub
Fast Facts: Biosimilars
About this book
Biosimilars have been in clinical use for more than 10 years, and evidence from more than 700 million patient-days' exposure shows that approved biosimilars can be used as safely and effectively as their originator biologics. And yet concerns about these drugs persist, particularly in therapy areas where they are recent additions to the formulary. It is vital to address these concerns so that clinicians can prescribe biosimilars with confidence, realizing substantial cost savings and improving patient access to effective treatments. 'Fast Facts: Biosimilars' provides a comprehensive yet concise explanation of biosimilars: what they are, how they are regulated, and how they are used in clinical practice. It is ideal for healthcare professionals and decision makers who want to understand biosimilars and the key concerns and controversies around these valuable products.
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Yes, you can access Fast Facts: Biosimilars by P. Cornes,D.J. Bennett,Paul Cornes,David J. Bennett in PDF and/or ePUB format, as well as other popular books in Medicine & Oncology. We have over one million books available in our catalogue for you to explore.
Information
| 5 | What has been the experience with biosimilar medicines to date? |
Four generations of biosimilars have been developed, with increasingly complex structures (Table 5.1); the patents on two oncology monoclonal antibodies are due to expire imminently: trastuzumab (Herceptin®, Roche) and bevacizumab (Avastin®; Genentech/Roche).
Variable uptake of biosimilars: the European experience
Biosimilars have been available in Europe for more than a decade, since the first biosimilar (human growth hormone, Omnitrope®) was approved in 2006; more than 30 biosimilars had been approved at the start of September 2017, listed in Table 5.2. Patient exposure to European-approved biosimilars over this period has been more than 700 million patient-days, with no signal that these less-costly biosimilars have any meaningful difference in safety or efficacy from their originator biologics. By contrast, only six biosimilars are currently approved in the USA (Table 5.3).
TABLE 5.1 Four generations of biosimilars | |||
First | Second | Third | Fourth |
Hormone replacement: • Erythropoietin • Filgrastim • HGH • Insulin • FSH | Low-molecular-weight heparins | Anti-inflammatory monoclonal antibodies & antibody fusion proteins: • Infliximab • Etanercept • Adalimumab • (rituximab) | Oncologicsa • Rituximab |
aPatent expiry is imminent for trastuzumab (HerceptinTM) and bevacizumab (AvastinTM). FSH, follicle stimulating hormone; HGH, human growth hormone. | |||
TABLE 5.2 Biosimilars approved in the EU (at September 2017) | |||
Active drug substance | Medicine name | Authorization date | Marketing authorization holder |
Adalimumab | Amgevita | 22 March 2017 | Amgen Europe |
Imraldi | 24 Aug 2017 | Samsung Bioepis UK (SBUK) | |
Solymbic | 22 March 2017 | Amgen Europe | |
Enoxaparin sodium | Inhixa | 15 Sept 2016 | Techdow Europe |
Thorinane | 15 Sept 2016 | Pharmathen | |
Epoetin alfa | Abseamed | 28 Aug 2007 | Medice Arzneimittel Pütter |
Binocrit | 28 Aug 2007 | Sandoz | |
Epoetin Alfa Hexal | 28 Aug 2007 | Hexal | |
Epoetin zeta | Retacrit | 18 Dec 2007 | Hospira UK |
Silapo | 18 Dec 2007 | Stada Arzneimittel | |
Etanercept | Benepali | 14 Jan 2016 | Samsung Bioepis UK (SBUK) |
Erelzi | 23 June 2017 | Sandoz | |
Filgrastim | Accofil | 18 Sept 2014 | Accord Healthcare |
Filgrastim Hexal | 6 Feb 2009 | Hexal | |
Grastofil | 18 Oct 2013 | Apotex Europe | |
Nivestim | 8 June 2010 | Hospira UK | |
Ratiograstim | 15 Sept 2008 | Ratiopharm | |
Tevagrastim | 15 Sept 2008 | Teva | |
Zarzio | 6 Feb 2009 | Sandoz | |
Follitropin alfa | Bemfola | 27 Mar 2014 | Gedeon Richter |
Ovaleap | 27 Sept 2013 | Teva Pharma | |
Infliximab | Flixabi | 26 May 2016 | Samsung Bioepis UK (SBUK) |
Inflectra | 10 Sept 2013 | Hospira UK | |
Remsima | 10 Sept 2013 | Celltrion Healthcare Hungary | |
Insulin glargine | Abasaglar (previously Abasria) | 9 Sept 2014 | Eli Lilly Regional Operations |
Lusduna | 4 Jan 2017 | Merck (MSD) | |
Insulin lispro | Insulin lispro Sanofi | 19 July 2017 | Sanofi-Aventis Groupe |
Rituximab | Blitzima | 13 July 2017 | Celltrion Healthcare Hungary |
Ritemvia | 13 July 2017 | Celltrion Healthcare Hungary | |
Rituzena (previously Tuxella) | 1... | ||
Table of contents
- Cover
- Title Page
- Copyright
- Contents
- Glossary
- Introduction
- An introduction to biologics and biosimilar medicines
- Why do we need biosimilar medicines?
- How is the quality of biosimilar medicines assured?
- How is the efficacy and safety of biosimilar medicines ensured?
- What has been the experience with biosimilar medicines to date?
- The future of biosimilar medicines
- How do I use biosimilar medicines?
- Useful resources
- Index