Global settlement clears a pathway for trastuzumab biosimilar Posted 17/03/2017

Generics giant Mylan Pharmaceuticals (Mylan) announced on 13 March 2017 that it had agreed to the terms of a global settlement with Genentech and Roche in relation to patents for Herceptin (trastuzumab), which provides Mylan with global licences for its trastuzumab biosimilar.

The global licence for trastuzumab has been granted in return for Mylan’s promise to withdraw challenges to two of Genentech’s US patents (patent numbers 6,407,213 and 6,331,415).

Mylan and partner, Indian biosimilars major Biocon, have approvals for their trastuzumab biosimilar pending in both Europe and the US [1, 2]. The global licence, according to Mylan, ‘will provide a clear pathway for Mylan to commercialize its trastuzumab product in various markets around the world’. The licences pertain to all countries except Japan, Brazil and Mexico. However, the effective dates were not disclosed.

The settlement removes ‘legal uncertainty’, as Mylan puts it, and the company adds that it ‘anticipates potentially being the first company to launch a biosimilar to Herceptin in the US’.

Herceptin had 2016 worldwide sales of CHF 6.8 billion (US$6.7 billion). The patents on Herceptin will expire in the US in June 2019 and expired in Europe in July 2014 [3].

The partnership also won a court ruling from the Delhi High Court allowing them to sell their trastuzumab ‘similar biologic’ (CanMab/Hertraz) in India where it has been approved since October 2013 [4]. Roche has fought against the introduction of the drug in India claiming that the country’s drug regulator had approved the Mylan and Biocon drug before it had adopted guidelines for how biosimilars would be approved.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon submit trastuzumab biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 17]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-trastuzumab-biosimilar-to-EMA
2. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon submit trastuzumab biosimilar to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 17]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-trastuzumab-biosimilar-to-FDA
3. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 17]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
4. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 17]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India

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Source: Mylan, The Statesman

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