Mylan Launches Brabio, First Generic Alternative to Copaxone® 40 mg/ml, for Multiple Sclerosis Patients in the UK

Mylan N.V. (NASDAQ, TASE: MYL) today announced the launch of Brabio (glatiramer acetate injection) 40 mg/ml,[1] the first available therapeutically equivalent version of Teva’s Copaxone® indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system.[2]

It is expected that Brabio will be available at a lower acquisition cost to the NHS, which is currently seeking to expand its use of best value medicines following the launch of its ‘Medicines Value Programme’. This initiative aims to improve health outcomes by diverting budget to other areas of need without compromising on treatment.

Mylan Europe President Jacek Glinka commented, “Bringing a more affordable, more accessible treatment option to market for patients with multiple sclerosis has been a priority for Mylan. Approximately 100,000 people in the UK live with MS, and today’s launch of Brabio demonstrates our commitment to those patients and healthcare professionals. We are dedicated to this important patient community and continued efforts to bring lower-cost, high-quality therapeutic equivalent versions of Copaxone to market in the UK and around the world.”

In January 2018, the UK's Court of Appeal refused Teva’s request to appeal the UK High Court of Justice’s decision in favor of Mylan and its European partner Synthon, finding all claims of Teva's patent EP (UK) 2 949 335 (EP 335) relating to Copaxone® 40 mg/mL invalid based on obviousness. This victory cleared the way for Mylan to launch Brabio in the UK.

[1] Equivalence of Generic Glatiramer Acetate in Multiple Sclerosis: A Randomized Clinical Trial

https://jamanetwork.com/journals/jamaneurology/fullarticle/2451333?utm_campaign=articlePDF&utm_medium=articlePDFlink&utm_source=articlePDF&utm_content=jamaneurol.2015.2154

[2] SmPC for Brabio 40mg/ml (http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1510288494619.pdf)