Pfizer launching biosimilars in US and Japan but not in EU

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Pfizer launching biosimilars in US and Japan but not in EU

Biosimilares/Novedades | Posted 14/02/2020 0 Post your comment

In early 2020, pharma giant Pfizer announced that it was launching its rituximab biosimilar in Japan and that it would be launching three new biosimilars onto the US market.

On 20 January 2020, Pfizer launched its biosimilar version of Roche/Chugai’s cancer drug Rituxan (rituximab) in Japan. The company gained Japanese approval for its infliximab biosimilar (Infliximab biosimilar 3) in July 2018. The biosimilar is Pfizer’s first biosimilar approved in Japan and is the third infliximab biosimilar approved in the country [1]. Pfizer’s biosimilar is the second rituximab biosimilar to hit the Japanese market after one by Sandoz/Kyowa Kirin, which has been available on the market since January 2018.

The company’s bevacizumab biosimilar, Zirabev (bevacizumab-bvzr), was launched on the US market on 31 December 2019. Zirabev references Genentech’s Avastin which can be used to treat a range of cancer types.

Zirabev will be available at a wholesale acquisition cost (WAC) of just over US$61.34 per 10 mg, which is almost 25% cheaper than that of Avastin. The biosimilar was approved by the US Food and Drug Administration (FDA) in June 2019 [2] for the treatment of metastatic colorectal cancer, recurrent or metastatic non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma and persistent, recurrent or metastatic cervical cancer. It was also approved in Europe in February 2019 [3].

Ruxience (rituximab-pvvr) was introduced to the US market on 23 January 2020. It references Roche’s MabThera/Rituxan (rituximab), but will be 24% cheaper than Rituxan at a wholesale acquisition cost at a WAC of US$71.68 per 10 mg. The biosimilar was approved by FDA in July 2019 [2] for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

Trazimera (trastuzumab-qyyp) was approved by FDA in March 2019 [2] for the treatment of human epidermal growth factor receptor 2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. It will be available to the US market on 15 February 2020. Trazimera references Roche’s Herceptin (trastuzumab) and will be available at a WAC of US$80.74 per 10 mg, which is 22% cheaper than Herceptin.

However, despite all these launches, Pfizer announced, in its fourth quarter and full-year 2019 results, that it does not plan to market its adalimumab biosimilar, Amsparity, in Europe. This is despite having received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use in December 2019 [4].

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Biosimilars approved in the US

References
1. GaBI Online - Generics and Biosimilars Initiative. Pfizer gains Japanese approval for infliximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 14]. Available from: www.gabionline.net/Biosimilars/News/Pfizer-gains-Japanese-approval-for-infliximab-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 14]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
3. GaBI Online - Generics and Biosimilars Initiative. EC approval for bevacizumab biosimilar Zirabev [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 14]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-bevacizumab-biosimilar-Zirabev
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 14]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: Pharma Japan, Pfizer