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EMA accepts applications for pegfilgrastim and trastuzumab biosimilars from Biocon/Mylan Posted 08/12/2017

India-based biologicals specialist Biocon and US-based partner Mylan announced on 1 December 2017 that the applications for approval for their proposed pegfilgrastim (MYL‑1401H) and trastuzumab (MYL‑1401O) biosimilars have been accepted by the European Medicines Agency (EMA).

EMA’s acceptance follows the withdrawal of the initial applications in August 2017, as part of EMA’s procedural requirements linked to the re-inspection of the company’s Bangalore drug product facility [1]. The companies have now completed Corrective and Preventive Actions (CAPAs) set out by EMA, which included the modification of the aseptic drug product facility. They expect these CAPAs to be verified during inspection as part of the review process.

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers.

Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. It serves to stimulate the level of white blood cells (neutrophils). Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy.

MYL‑1401O is a proposed biosimilar to Roche’s Herceptin (trastuzumab), which had worldwide sales of CHF 6.5 billion (US$6.6 billion) in 2015 [2]. The patents on Herceptin expired in Europe in July 2014 and will expire in the US in June 2019 [3].

MYL‑1401H is a proposed biosimilar to Amgen’s Neulasta (pegfilgrastim), which had worldwide sales of US$4.7 billion in 2015 [4]. The patents on Neulasta expired in the US in October 2015 and expired in Europe in August 2017 [3].

EMA has yet to approve a pegfilgrastim biosimilar, but approved a trastuzumab biosimilar, Ontruzant, made by Samsung Bioepis in September 2017 [5].

Related article
Biosimilars approved in Europe

References
1. GaBI Online - Generics and Biosimilars Initiative. Biocon withdraws EU applications for trastuzumab and pegfilgrastim biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Dec 8]. Available from: www.gabionline.net/Biosimilars/General/Biocon-withdraws-EU-applications-for-trastuzumab-and-pegfilgrastim-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Dec 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-trastuzumab
3. Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Dec 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-pegfilgrastim
5. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Ontruzant [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Dec 8]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-trastuzumab-biosimilar-Ontruzant

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Source: Biocon, Mylan

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