Sandoz, the generics division of Novartis, announced on 11 February 2016 that its regulatory submission for its proposed pegfilgrastim biosimilar (LA-EP2006) had been accepted by the European Medicines Agency (EMA).
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 (white blood cells) to fight infection in patients undergoing chemotherapy.
The product is a proposed biosimilar to Amgen’s Neulasta (pegfilgrastim), which had worldwide sales of US$5.8 billion in 2014, making it a lucrative target for biosimilars manufacturers. The patents on Neulasta expired in the US in October 2015 and in Europe in August 2017 [1].
Sandoz is seeking approval for its biosimilar in the same indications as the reference product (Neulasta), which includes three pivotal clinical trials – one pharmacokinetic and pharmacodynamic study in healthy volunteers and two comparative efficacy and safety studies in breast cancer patients – to demonstrate that the proposed biosimilar is highly similar to the reference product.
Sandoz already has three biosimilars approved in the European Union: Binocrit (epoetin alfa), Omnitrope (somatropin) and Zarzio (filgrastim) [2]. The company also gained US approval for its filgrastim biosimilar, Zarxio (filgrastim-sndz), in March 2015 [3] – the first biosimilar approved in the US. It has also submitted applications for approval of its etanercept (GP2015) and pegfilgrastim (LA-EP2006) biosimilars to the US Food and Drug Administration [4, 5] and for approval of its etanercept (GP2015) biosimilar to EMA [6].
Sandoz currently has five biosimilars that are in phase III clinical trials or are undergoing registration, including adalimumab (based on Humira from AbbVie) for patients with autoimmune diseases. The company plans to make 10 regulatory filings over the three-year period from 2015 to 2017.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 19]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 19]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. Zarxio first biosimilar to be launched in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 19]. Available from: www.gabionline.net/Biosimilars/News/Zarxio-first-biosimilar-to-be-launched-in-US
4. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 19]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-etanercept-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 19]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-pegfilgrastim-biosimilar
6. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for etanercept biosimilar biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 19]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-etanercept-biosimilar
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