Immunology and Biotherapies
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Page Ressources et Actualités du DIU immunologie et biothérapies
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Rescooped by Gilbert C FAURE from Top Selling Monoclonal Antibodies 2014
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Measures of biosimilarity in monoclonal antibodies in oncology: the case of bevacizumab

Measures of #biosimilarity in monoclonal antibodies in oncology: case of bevacizumab #mAbs #biosimilars #biosimilar
http://t.co/EmMApVxrEy

 

Highlights

 

Challenges remain in establishing biosimilarity of anticancer agents.

Preclinical studies can be sensitive but can lack clinical relevance.

It is not realistic to establish noninferiority of biosimilar bevacizumab using accepted clinical outcomes.

Novel clinical endpoints may include adverse reactions or unauthorized indications.

The authorization of biosimilars in oncology at realistic costs requires novel approaches.


Via Krishan Maggon
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Krishan Maggon 's curator insight, April 11, 2015 9:30 AM

Drug Discovery Today

Volume 18, Issues 17–18, September 2013, Pages 872–879

Review Measures of biosimilarity in monoclonal antibodies in oncology: the case of bevacizumabHans C. Ebbers1, Peter J.K. van Meer3, Ellen H.M. Moors2, Aukje K. Mantel-Teeuwisse1, , , Hubert G.M. Leufkens1, Huub Schellekens2, 3Available online 18 May 2013  doi:10.1016/j.drudis.2013.05.004

Rescooped by Gilbert C FAURE from Top Selling Monoclonal Antibodies 2014
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Best Selling Monoclonal Antibodies 2013

Best Selling Monoclonal Antibodies 2013 | Immunology and Biotherapies | Scoop.it

Via Krishan Maggon
Gilbert C FAURE's insight:

impressive for immunologists so far away from so big amounts of money

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Krishan Maggon 's curator insight, January 6, 2014 8:38 AM

Abstract

 

A review of the best selling monoclonal antibodies in 2013 and 2012 is provided. Humira with sales of over $11 billion ($9.3 billion in 2012) remains the best selling monoclonal antibody, biologic as well prescription drug brand in 2013 as in 2012. The ranks of the next 4 top selling mabs remained unchanged from the 2012 Table.  Remicade (9.7 Bn), Rituxan (7.5 Bn) , Herceptin (6.5 Bn) and Avastin (6.5 Bn) were the second, third, fourth and fifth top selling mabs in 2013. The actual sales for 2013 as reported by the companies are provided. The total sales of the top selling blockbuster mabs were $63 billion in 2013. The actual global sales of all the approved blockbuster sales or potential (sales >1 billion) monoclonal antibodies in 2013 is provided. Besides the top 5 mabs, there were 2 other monoclonal antibodies with sales of over 2 billion dollars and 5 with sales of over $ 1 billion in 2013. In addition 5 recently launched mabs were nearing to reach sales of $ 1 billion this year. Currently 30 monoclonal antibodies are marketed in the US and Europe (January 2014).  Alexion Soliris was the most expansive marketed monoclonal antibody with a price tag of $440,000 per year of treatment, a sort of Rolls-Royce of mabs.

 

Rescooped by Gilbert C FAURE from Top Selling Monoclonal Antibodies 2014
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Antibody therapies and their challenges in the treatment of age-related macular degeneration

Abstract

Age-related macular degeneration (AMD) is the leading cause of vision loss in the western world. This multifactorial disease results from the combined contributions of age, environment and genetic predisposition. Antibody-based treatment of late-stage neovascular AMD with inhibitors of vascular endothelial growth factor has had great success, which is now the goal for currently untreatable AMD manifestations. The existence of an immune-privileged environment in the eye supports the feasibility of localized antibody therapy. Many different antibodies against various targets are being developed for the treatment of AMD, which reflects the etiological complexity of the disease. This review provides an overview of 19 potential therapeutic antibodies targeting angiogenesis, the complement system, inflammation or amyloid beta deposition in the eye. It summarizes the immunoglobulin structure, the specific target and study outcomes for each approach. The latter include beneficial results or adverse effects in AMD models and patients. Finally, this article discusses the challenges in the development of antibody-based drugs to treat degenerative processes in the posterior eye. In spite of these difficulties, to date, the following four antibodies have overcome the technical and preclinical hurdles and are being tested in active clinical studies: Lampalizumab, Sonepcizumab, GSK933776 and LFG316. We conclude that, while there are some antibody-based drugs that have made it into clinical practice, a successful transfer from bench to beside is still pending for many promising approaches.

 


Via Krishan Maggon
Gilbert C FAURE's insight:
Nineteen antibodies in the development for AMD treatment are described. • Antibody targets are: angiogenesis, complement, inflammation or amyloid β. • Antibody therapy faces known challenges of chemical drugs. • Antibody structure, specificity and effector function offer new possibilities. • An anti-AMD “toolbox” is more likely for dry AMD therapy than a “magic bullet”.
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Krishan Maggon 's curator insight, March 23, 2015 4:36 AM

Highlights

 

Nineteen antibodies in the development for AMD treatment are described.

Antibody targets are: angiogenesis, complement, inflammation or amyloid β.

Antibody therapy faces known challenges of chemical drugs.

Antibody structure, specificity and effector function offer new possibilities.

An anti-AMD “toolbox” is more likely for dry AMD therapy than a “magic bullet”.