Pfizer has filed two petitions for IPR of U.S. Patent 8,591,897, owned by Genentech: IPR2017-01726 and IPR2017-01727. According to the petitions, the ‘897 patent is directed to methods for treating patients with non-metastatic HER2-positive breast cancer by administering anthracycline/cyclophosphamide (AC) based chemotherapy, followed by sequential administration of a taxoid and…
According to a Pfizer press release, the FDA has issued a second Complete Response Letter (CRL) to Pfizer in connection with the company’s aBLA for Retacrit, a proposed biosimilar of Epogen® and Procrit® (epoetin alpha). Pfizer said the CRL relates “to matters noted in a Warning Letter issued on February…
Pfizer, Inc. has filed two petitions (IPR2017-01488 and IPR2017-01489) challenging claims of U.S. Patent No. 6,407,213 (“the’213 patent”). According to the petitions, the ’213 patent is directed to methods of making humanized antibodies. The petitions do not identify a particular product that may use the patented methods. IPR petitions challenging the…
As we previously reported, the FDA Oncologic Drugs Advisory Committee (“ODAC”) held a public meeting today regarding Hospira’s application for its proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa). Pfizer, Hospira’s parent company, has announced today that ODAC recommended approval of their proposed epoetin alfa biosimilar across all indications. According to the press release,…
Pfizer, Inc. has filed two petitions for IPR of Chugai Pharmaceutical’s patents: IPR2017-01357 on U.S. Patent 7,332,289 and IPR2017-01358 on U.S. Patent 7,927,815. According to the petitions, both patents are directed to methods for purifying antibodies. The petitions do not identify a particular product that may use the patented methods….
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In the past few days, Pfizer has filed petitions for IPR of two of Biogen’s patents related to rituximab: IPR2017-01166 on U.S. Patent 8,329,172 and IPR2017-01167 on U.S. Patent 8,577,244. According to the petitions, the patents are directed to methods of treating non-Hodgkin’s Lymphoma with rituximab. The petitions are posted…
The FDA recently announced that the Oncologic Drugs Advisory Committee will hold a public meeting on May 25, 2017 to discuss Hospira’s application for a proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa). Pfizer (Hospira’s parent) announced earlier this year that it resubmitted the application in December 2016, following FDA’s rejection…
According to BioPharma-reporter, Pfizer will close the Australian plant at which Pfizer manufactures API for HSP-130, a biosimilar version of Amgen’s Neulasta, by 2021. Pfizer will move production of the API to Croatia in an effort to consolidate manufacturing. HSP130 is currently in clinical trials. Stay tuned to the Big…
Last fall, we reported on Pfizer’s 30% price cut to Enbrel® (etanercept) to comply with Ireland’s Framework Agreement on the Supply and Pricing of Medicines, which requires price reductions for off-patent branded biologic medicines for which biosimilars are available. Yesterday, the Irish Times published a follow-up article describing some of the market…