Tagged as: Pfizer

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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AbbVie and Pfizer Settle Adalimumab Biosimilar Patent Disputes

Today, AbbVie and Pfizer announced that they reached a global resolution of all intellectual property-related litigation concerning Pfizer’s proposed biosimilar adalimumab.  According to the press releases, AbbVie has granted Pfizer a non-exclusive license to AbbVie’s intellectual property relating to adalimumab in the United States and other countries.  All litigation pending between the parties…

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United States Intervenes in Genentech Constitutional Challenge

We have covered Pfizer’s development of biosimilars of Genentech’s Avastin® (bevacizumab) and Herceptin® (trastuzumab) and its related IPR filings IPR2016-01771 and IPR2016-01837. Following written decisions invalidating those two patents, Genentech appealed and challenged the constitutionality of subjecting patents that issued before the America Invents Act (AIA) was enacted in 2011…

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Pfizer Submits Citizen Petition to FDA Regarding Communications About Biosimilars

On August 22, 2018, Pfizer submitted a citizen petition to the Food and Drug Administration requesting “guidance clarifying appropriate sponsor communications about the nature and properties of biosimilar products.”  Specifically, Pfizer petitioned FDA to clarify what constitutes a false and misleading communication with respect to the safety and effectiveness of biosimilars relative…

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