Epoetin alfa and pegfilgrastim biosimilars have been launched in the US at a significant discount compared to their originators.
US-based biosimilars specialist Coherus BioSciences (Coherus) announced on 8 November 2018 that it would price its pegfilgrastim biosimilar at a 33% discount to the originator, Amgen’s neutropenia treatment Neulasta (pegfilgrastim).
Coherus submitted its application for approval of Udenyca (pegfilgrastim-cbqv) to the US Food and Drug Administration (FDA) in October 2016 [1]. The application was delayed, however, after Coherus received a complete response letter (CRL) from the agency saying that it wanted a ‘re-analysis of a subset of subject samples with a revised immunogenicity assay’ and ‘certain additional manufacturing related process information’ [2]. The company finally received approval for Udenyca from FDA on 2 November 2018 [3].
Coherus has set a list price of US$4,175 per unit, which is the same as that for Mylan’s pegfilgrastim biosimilar, Fulphila, which was approved by FDA, as the first pegfilgrastim biosimilar in the US, in June 2018 [4].
And on 14 November 2018, it was reported that US pharma giant Pfizer had launched its epoetin alfa biosimilar, Retacrit (epoetin alfa-epbx), in the US at a significant discount. According to reports, Pfizer began shipping Retacrit to wholesalers on 12 November 2018 at a list price of US$11.03 per 1,000 units/mL, a 57% discount compared to Amgen’s Procrit and a 33.5% discount compared to Johnson & Johnson’s Epogen.
FDA approved Retacrit, as the first US epoetin alfa biosimilar, on 15 May 2018 [5]. This is Pfizer’s third biosimilar launch in the US. The company launched Inflectra (infliximab-dyyb) in November 2016 and Nivestym (filgrastim-aafi) in October 2018. Pfizer also received FDA approval for its filgrastim biosimilar Nivestym (filgrastim-aafi) in July 2018 [6].
Pfizer’s subsidiary Hospira is still involved in patent litigation against Amgen regarding the development of Retacrit. In September 2018, a Delaware federal jury awarded Amgen US$70 million in damages, after finding that Hospira infringed a now-expired Amgen process patent [7]. The case is currently on appeal before the Federal Circuit.
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for pegfilgrastim biosimilar from Coherus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 14]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-pegfilgrastim-biosimilar-from-Coherus
2. GaBI Online - Generics and Biosimilars Initiative. FDA rejects pegfilgrastim biosimilar from Coherus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 14]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-pegfilgrastim-biosimilar-from-Coherus
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab and pegfilgrastim biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 14]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-adalimumab-and-pegfilgrastim-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. FDA approval for pegfilgrastim biosimilar Fulphila [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 14]. Available from: www.gabionline.net/Biosimilars/News/FDA-approval-for-pegfilgrastim-biosimilar-Fulphila
5. GaBI Online - Generics and Biosimilars Initiative. FDA approves epoetin alfa biosimilar Retacrit [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 14]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-epoetin-alfa-biosimilar-Retacrit
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 14]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
7. GaBI Online - Generics and Biosimilars Initiative. Hospira to pay Amgen US$70 million for epoetin alfa patent infringement [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 14]. Available from: www.gabionline.net/Biosimilars/General/Hospira-to-pay-Amgen-US-70-million-for-epoetin-alfa-patent-infringement
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Source: Big Molecule Watch, Reuters
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