FDA Approves Pfizer's Trastuzumab Biosimilar
Pfizer’s approval for trastuzumab in the US marks the fourth FDA nod for a biosimilar rival to Genentech’s Herceptin original. However, while two of those biosimilar sponsors continue to be engaged in patent litigation with the originator, Pfizer and Mylan have both struck settlement deals.
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By mid-February next year, Pfizer plans to have introduced in the US bevacizumab, rituximab and trastuzumab biosimilars to Avastin, Rituxan and Herceptin.
As Pfizer prepares for biosimilars launches in the US, its Biopharma unit has enjoyed 3% growth in the first half of 2019.
Pfizer has received approval from the US Food and Drug Administration for the country’s second biosimilar rituximab, under the Ruxience label. However, the company has not yet revealed launch plans for the rival to Roche’s Rituxan brand.