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Candidate trastuzumab biosimilar meets equivalence requirements Posted 03/03/2017

Mylan and Biocon reported that their jointly developed, candidate trastuzumab biosimilar (MYL-1401O), had met equivalence requirements. The results of the study were published in the Journal of the American Medical Association (JAMA) in January 2017 [1].

US generics and specialty pharmaceutical’s company Mylan, and Indian biopharmaceutical company Biocon are exclusive partners on a number of biosimilar and insulin products. Their candidate trastuzumab biosimilar, MYL-1401O, is one of six biologicals under co-development for the global marketplace. The originator, Roche’s Herceptin, is used in the treatment of gastric cancers and HER2+ breast cancer [2]. The patent on Herceptin, which had sales of US$6.6 billion in 2015 [3], expired in Europe in 2014 and is due to expire in the US in 2019 [4].

The partnership reported that the results from their phase III HERiTAge study ‘confirm the efficacy, safety and immunogenicity of MYL-1401O, in comparison to branded trastuzumab’. The multicentre, double-blind, randomized, parallel-group, phase III equivalence study was carried out between 2012 and 2015. It included 500 women with HER2+ metastatic breast cancer without prior treatment for metastatic disease.

Patients received either MYL-1401O or originator trastuzumab and were administered with chemotherapy taxanes, docetaxel or paclitaxel, for a minimum of eight cycles (24 weeks), followed by antibody alone until unacceptable toxic effects or disease progression occurred. The intention-to-treat population included 458 patients and the primary outcome was to assess their overall response rate to the candidate biosimilar plus a taxane at 24 weeks. The overall response rate at 24 weeks was 69.6% for MYL-1401O compared to 64% for Herceptin. No statistical differences were reported in the secondary outcome measures, which included tumour progression, progression-free survival and overall survival between MYL‑1401O and Herceptin at week 48.

Mylan and Biocon first presented trial results at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Society for Medical Oncology (ESMO) Congress. The partnership claim that their results indicate that the use of MYL-1401O compared to Herceptin exhibited an ‘equivalent overall response rate at 24 weeks’. They also report that ‘further study is needed to assess safety and long-term clinical outcome’.

In their press release, Rajiv Malik, Mylan President, said that ‘Once approved, we believe our proposed biosimilar trastuzumab will provide a lower cost treatment option for breast cancer patients. We look forward to continuing our industry-leading role with Biocon to expand patient access across the globe to this critically important medicine as well as Mylan's broad portfolio of 15 additional biologic[al]s and insulin analogues currently in development’.

Mylan and Biocon submitted an application for their proposed trastuzumab biosimilar (Myl-1401O) to the European Medicines Agency in August 2016 [5]. In the event of success, Mylan has exclusive commercialization rights for the proposed trastuzumab biosimilar in Australia, Canada, Japan, New Zealand, the US, European Union and European Free Trade Association countries. In the rest of the world, Biocon shares co-exclusive commercialization rights of the product with Mylan.

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1. Rugo HS, et al. Effect of a proposed trastuzumab biosimilar compared with trastuzumab on overall response rate in patients with ERBB2 (HER2)–positive metastatic breast cancer:  a randomized clinical trial. JAMA 2017;317(1):37-47.
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 4]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-trastuzumab-biosimilar-to-FDA 
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 4]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-trastuzumab
4. Derbyshire M. Patent expiry dates for best-selling biologicals, Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(4):178-9. doi:10.5639/gabij.2015.0404.040
5. 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 4]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-trastuzumab-biosimilar-to-FDA

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Source: Mylan

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