In its first quarter (1Q) 2020 earnings call Amgen revealed that it had received a target action date from the US Food and Drug Administration (FDA) for its rituximab biosimilar ABP 798. FDA has committed to review the company’s biosimilar application by 19 December 2020.

Biotech giant Amgen, and its partner Allergan, submitted the application for review of ABP 798 to FDA in December 2019 [1]. The submission followed the publication of positive data from a phase III study of ABP 798 compared to Rituxan (rituximab) in non-Hodgkin's lymphoma (NHL) patients in August 2019 [2].

Amgen also said in its 1Q 2020 earnings call that its adalimumab biosimilar Amgevita (ABP 501) was ‘adding to their inflammation franchise’. In fact, sales of Amgevita in Europe have been steadily increasing with 1Q net sales of US$86 million in 2020 compared to US$31 million in 1Q 2019. Amgevita, was launched in Europe in October 2018 [3] after it received approval in March 2017 [4].

However, on the other side of the wall, Amgen is also claiming patent infringement for a patent on one of its originator biologicals, Neupogen (filgrastim). In the lawsuit, Amgen vs Hospira and Pfizer, Amgen claims that Hospira/Pfizer’s filgrastim biosimilar Nivestym (filgrastim-aafi) infringes its 10,577,392 patent (’392 patent), which covers a process for purifying proteins.

Nivestym was approved by FDA in July 2018 [5] and was launched shortly afterwards.

Amgen says that Hospira/Pfizer ‘have manufactured, used, sold, and/or offered for sale within the United States, and/or imported into the United States, the Hospira Filgrastim Biosimilar Product before the expiration of the ’392 Patent’. The company claims that at least by 24 September 2018, Hospira/Pfizer ‘began to import the Hospira Filgrastim Biosimilar Product into the United States, and Defendants began to offer to sell, sell, or use the Hospira Filgrastim Biosimilar Product within the United States’.

Amgen also alleges that Hospira/Pfizer breached requirements for information exchange under 42 U.S.C. § 262(l). The company says that it initially only received 10,000 pages of the abbreviated biological licence application (aBLA). However, it became apparent that some sections were missing but were cross-referenced in the provided pages. Hospira/Pfizer then belatedly provided a further 70,000 additional pages, which the pair say ‘were inadvertently not included … in the original production’.

Amgen is claiming loss of profits and price erosion on Neupogen due to the patent infringement. The only problem with the whole situation is that the patent was only issued on 2 March 2020.

Related articles
Amgevita approved in Colombia

Clinical trials for adalimumab biosimilar ABP 501

Biosimilars of rituximab

References
1. GaBI Online - Generics and Biosimilars Initiative. Rituximab biosimilar ABP 798 submitted to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 22]. Available from: www.gabionline.net/Biosimilars/News/Rituximab-biosimilar-ABP-798-submitted-to-FDA
2. GaBI Online - Generics and Biosimilars Initiative. More positive phase III results for rituximab biosimilar ABP 798 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 22]. Available from: www.gabionline.net/Biosimilars/Research/More-positive-phase-III-results-for-rituximab-biosimilar-ABP-798
3. GaBI Online - Generics and Biosimilars Initiative. Adalimumab biosimilars Amgevita and Imraldi launched in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 22]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-biosimilars-Amgevita-and-Imraldi-launched-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 22]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 22]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US

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