India-based generics maker Lupin, which is expecting European approval for its etanercept biosimilar in March 2020, has announced plans to launch the drug on the US market soon after, alongside a pegfilgrastim biosimilar.
Lupin’s biosimilar of etanercept was approved in Japan in March 2019 [1] and is currently awaiting approval from the European Medicines Agency (EMA). Etanercept is an autoimmune disease treatment that targets the inflammatory cytokine tumour necrosis factor (TNF). It can be used to treat various forms of arthritis and has previously been marketed by Amgen as Enbrel.
Lupin has now announced plans to take the drug to the US market, alongside a biosimilar of pegfilgrastim, which stimulates the production of white blood cells and helps patients undergoing chemotherapy to ward off infection. It was also originally marketed by Amgen, with the brand name Neulasta.
Lupin is expecting to launch its etanercept biosimilar on the European market by July 2020, and aims to file for approval for both drugs in the US by the fourth quarter of the same year.
‘We already have API [active pharmaceutical ingredient] and drug facility approval from EMA and are expecting final approvals by March 2020. We expect to get pricing approvals, and launch etanercept in Europe by July 2020’, said Dr Cyrus Karkaria, President of Lupin’s Biosimilars Division. Lupin will compete in Europe with rival etanercept biosimilars from Sandoz and Samsung Bioepis.
The company has formed a collaboration with US drugmaker Mylan [2] to bring its products to Asia, Australia, Europe and New Zealand. Regarding the US market, Dr Karkaria discussed potential issues with the US Food and Drug Administration’s (FDA) guidelines on interchangeability.
‘FDA’s interchangeability guidelines on biosimilars will be beneficial for generics […]. However, so far no biotech product has gone through interchangeability trials. Once FDA ratifies it, we will evaluate our position. We are currently assessing the market opportunity as interchangeability is needed at the pharmacy level and not at the payer level.’
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References
1. GaBI Online - Generics and Biosimilars Initiative. Japanese approval for Lupin’s etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 29]. Available from: www.gabionline.net/Biosimilars/News/Japanese-approval-for-Lupin-s-etanercept-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Mylan and Lupin make deal for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 29]. Available from: www.gabionline.net/Pharma-News/Mylan-and-Lupin-make-deal-for-etanercept-biosimilar
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