FDA accepts applications for three-times-weekly follow-on Copaxone

Biosimilars/News | Posted 05/09/2014 post-comment0 Post your comment

The US Food and Drug Administration (FDA) has accepted applications submitted by generics makers Dr Reddy’s, Sandoz (Momenta Pharmaceuticals’ development and commercialization partner), and Mylan for three-times-weekly follow-on versions of blockbuster multiple sclerosis drug Copaxone (glatiramer acetate).

24 AA011041

The news comes as a blow to Teva Pharmaceuticals (Teva), which only received approval for the three-times-weekly formulation of Copaxone in January 2013 [1]. The 40 mg/mL allows for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of multiple sclerosis. The company was therefore hoping to switch patients from daily to weekly Copaxone to avoid generic erosion of the daily version (20 mg/mL), which became open to generics competition in May 2014.

On 28 August 2014, both Mylan and the Momenta/Sandoz collaboration announced that they had had abbreviated new drug applications (ANDAs) for their three-times-weekly follow-on glatiramer acetate injection 40 mg/mL products accepted for filing by FDA. The companies believe that they are the first to file a substantially complete ANDA containing a Paragraph IV certification for this product and expect to be eligible for 180 days of marketing exclusivity in the US upon final FDA approval.

Teva responded by saying that it would ‘continue to vigorously defend its Copaxone intellectual property rights against infringement wherever they are challenged’. The company stated that it ‘intends to file a lawsuit for patent infringement’, adding that ‘Copaxone 40 mg/mL is protected by two Orange Book patents that expire in 2030’.

Copaxone 40 mg/mL had US sales of approximately US$411.5 million for the 12 months ending 30 June 2014, according to IMS Health.

Related Article
Copaxone stay rejected and balugrastim withdrawn

Teva loses fight against generic glatiramer acetate

1.    GaBI Online - Generics and Biosimilars Initiative. Teva gains FDA approval for three-times-a-week Copaxone [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 5]. Available from: www.gabionline.net/Biosimilars/General/Teva-gains-FDA-approval-for-three-times-a-week-Copaxone

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2014 Pro PharmaCommunications International. All Rights Reserved.

Source: FDA, Momenta, Mylan

comment icon Comments (0)
Post your comment
Related content
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010