Views on biosimilars at Amgen and Actavis

Generics and biosimilars Initiative

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Views on biosimilars at Amgen and Actavis

INICIO/Noticias Farmacéuticas | Posted 20/06/2014 0 Post your comment

Biotech giant Amgen and US generics maker Actavis entered into a collaboration for the development and commercialization of several cancer antibody biosimilars back in December 2011 [1]. Now the two companies have spoken to GaBI about their views on biosimilars and their biosimilar plans [2].

Biosimilars education
Both companies agree there is a need for further education on the subject of biosimilars in order to establish confidence for those using biosimilars, i.e. physicians and patients.

Partnership model
The collaboration between Amgen and Actavis for biosimilars is not unusual. In fact, many companies are partnering on biosimilars development.

Amgen is developing six biosimilar monoclonal antibodies, four of which are in collaboration with Actavis. The company has extensive manufacturing capabilities for manufacturing both biosimilars and originator biologicals, and plans to launch its first biosimilars in 2017. Actavis is also developing a biosimilar outside of the Amgen joint venture.

Naming of biosimilars
Amgen is supporting the World Health Organization's proposal for a distinguishable feature for all biologicals [3], as being non-discriminatory. The company believes that such a biological qualifier will enable identification of the product, allowing product-level traceability, and allowing global pharmacovigilance to effectively trace biologicals including biosimilars.

The majority of EU Member States, however, have said that they strongly support that the names of biosimilars should be closely aligned with their reference product and that it is not problematic to identify which biological products are associated with adverse reaction reports [4]. In the EU, both the brand name and international nonproprietary name are used to identify the specific biological product, whether it is an originator product or a biosimilar.

Editor’s comment
Readers interested to learn more about the full interview are invited to visit www.gabi-journal.net to view the following manuscript planned in GaBI Journal 2014, Issue 3:

If you are interested in contributing a research or perspective paper to GaBI Journal, please send us your submission here.

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1. GaBI Online - Generics and Biosimilars Initiative. Amgen finally jumps on biosimilars bandwagon [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 20]. Available from: www.gabionline.net/Biosimilars/News/Amgen-finally-jumps-on-biosimilars-bandwagon
2. Derbyshire M. Biosimilars collaboration at Amgen and Actavis. Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(3):155-6. doi:10.5639/gabij.2014.0303.035
3. GaBI Online - Generics and Biosimilars Initiative. WHO investigates use of a biological qualifier for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 20]. Available from: www.gabionline.net/Biosimilars/General/WHO-investigates-use-of-a-biological-qualifier-for-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. EU majority says same INNs for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 20]. Available from: www.gabionline.net/Biosimilars/General/EU-majority-says-same-INNs-for-biosimilars

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Source: Amgen/Actavis interview with GaBI