Tagged as: Pfizer

Pfizer Announces U.S. Launch Dates for Three Biosimilars

Earlier this week, during its 3Q 2019 earnings call, Pfizer announced the U.S. launch dates for three of its biosimilar products: ZIRABEV (bevacizumab-bvzr), a biosimilar of Genentech’s AVASTIN, which received approval in June, will launch December 31, 2019.  We previously posted that on September 20, 2019, Genentech and Pfizer settled…

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Bevacizumab Litigation Update: Pfizer Answers Genentech’s Complaint and Genentech Moves to Dismiss Counterclaims

On April 29, 2019, Pfizer answered Genentech’s complaint alleging infringement of 22 patents based on Pfizer’s submission of an aBLA seeking U.S. FDA approval of a biosimilar of Avastin® (bevacizumab).  In its answer, Pfizer denied Genentech’s allegations of patent infringement and violations of the BPCIA’s patent dance procedures.  Pfizer also…

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Rituximab IPR Updates

Today, Pfizer filed a notice that it will not participate in the appeal of the final written decision of IPR2017-01168, which found all claims of U.S. Patent No. 8,821,873 unpatentable. The ‘873 patent is directed to a method of treating lymphoma with anti-CD20 antibodies. Yesterday, Pfizer and Biogen filed a joint…

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FDA approves a fourth biosimilar of HERCEPTIN

Yesterday, the U.S. FDA approved Pfizer’s Trazimera™ (trastuzumab-qyyp), a biosimilar of Genentech’s Herceptin®, for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.  These indications are the same as those for which the reference product is approved. Trazimera™ is the fourth trastuzumab biosimilar, and the…

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Pfizer Receives European Approval For Avastin® (Bevacizumab) Biosimilar

Pfizer announced today that the European Commission has approved its Avastin® (bevacizumab) biosimilar ZIRABEV™ for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer and persistent, recurrent or metastatic carcinoma…

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Pipeline Updates: Pfizer, Amgen, and Allergan

Earlier this month, it was reported by the Regulatory Affairs Professional Society (RAPs) that Pfizer has terminated five biosimilar projects in preclinical development.  According RAPs, Pfizer’s Director of Global Media Relations, Thomas Biegi, said that resources from these programs would be reallocated “to late stage programs across Pfizer’s other key…

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