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  • Regulatory NewsRegulatory News

    Population Pharmacokinetics: Drugmakers Seek Clarity and Additions to Revised FDA Guidance

    About a dozen drugmakers and industry groups recently offered their opinions on a revised US Food and Drug Administration (FDA) draft guidance related to population pharmacokinetics (PK) analyses submitted as part of new drug applications and biologic license applications. The comments largely seek specific tweaks to the 23-page revised draft, which was released in July , although some of the comments also seek further clarity and new additions to the guidance. Indu...
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    FDA Approves Two More Biosimilars

    The US Food and Drug Administration (FDA) on Tuesday approved the 22 nd and 23 rd biosimilars: Pfizer’s Ruxience (rituximab-pvvr), which is the second biosimilar to Roche’s Rituxan (rituximab), and Samsung Bioepis’s Hadlima (adalimumab-bwwd), which could end up being the ninth biosimilar to AbbVie’s Humira (adalimumab). Ruxience is approved as a treatment of adult patients with CD20-positive B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combin...
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    Another Biosimilar Approval From FDA, Another Unknown Launch Date

    The US Food and Drug Administration (FDA) on Friday approved Pfizer’s Zirabev (bevacizumab-bvzr), the 21 st biosimilar in the US and the second for Roche’s cancer treatment Avastin (bevacizumab). But the launch date in the US for Zirabev, a treatment for five types of cancer, remains unknown, as does the launch date for its predecessor, Amgen’s Mvasi (bevacizumab-awwb), approved in September 2017. Similarly, two Enbrel (etanercept) biosimilars have been approved, the f...
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    Pfizer Appoints Gottlieb to Board of Directors

    Following in the tradition of recently departed US Food and Drug Administration (FDA) commissioners, Scott Gottlieb is joining the board of directors at Pfizer. In addition to his role on the Pfizer board, Gottlieb, an elected member of the National Academy of Medicine, is also resident fellow at the American Enterprise Institute and a partner at the venture capital firm New Enterprise Associates. Reactions to Gottlieb’s decision to join the Pfizer board ranged from ...
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    Risk-Based Monitoring: Pfizer and BMS Seek Clarity on FDA Draft Guidance

    Pfizer and Bristol-Myers Squibb (BMS) recently raised questions with and sought further clarity from the US Food and Drug Administration (FDA) on a draft guidance related to the risk-based monitoring (RBM) of clinical trials. The eight-page RBM draft guidance , released in March, comes in the form of eight questions and answers. It expands on guidance from August 2013, known as “ Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring ,” by providing...
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    Industry Seeks Clarity on CGT Draft Guidance

    Pfizer, Perrigo, Teva, Apotex and the Association of Accessible Medicines all sought further clarity from the US Food and Drug Administration (FDA) on draft guidance related to the competitive generic therapy (CGT) designation and CGT exclusivity. The CGT designation is meant to be an incentive for industry to develop generics for drugs that have only one competitor. To date, FDA has granted more than 100 CGT designation requests, and in 2018, between August and Decembe...
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    Biopharma CEOs Explain Problems With Biosimilars to Congress

    Following their Senate Finance Committee hearing in February, all seven biopharmaceutical CEOs have now offered hundreds of pages of written responses to more specific questions. The lackluster biosimilar market in the US is addressed in nearly all their comments, with some executives explaining in detail as to why their biosimilars have yet to gain market share, while undertones of biosimilar fear-mongering linger in others’ comments. Merck CEO Kenneth Frazier expla...
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    Pfizer Uses EHR Data to Support Expanded Indication for Breast Cancer Drug

    In a move that may become more common as the US Food and Drug Administration’s (FDA) comfort with real-world data (RWD) increases, FDA on Thursday approved a new indication for Pfizer’s Ibrance (palbociclib) in combination with an aromatase inhibitor or fulvestrant to include men with certain types of metastatic breast cancer. The approval is based on RWD from electronic health records and postmarketing reports of Ibrance in male patients sourced from three databases: I...
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    Industry Calls on FDA to Streamline Process of Providing Marketing Status Updates

    Industry groups PhRMA and the Association for Accessible Medicines (AAM), as well as companies Pfizer and Teva Pharmaceuticals are calling on the US Food and Drug Administration (FDA) to tweak and clarify recently drafted guidance on marketing status updates. The draft guidance from January helps sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) understand what information they have to share with FDA on the marketing status of thei...
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    FDA Warns Jubilant, Pfizer Subsidiary in India

    The US Food and Drug Administration (FDA) last week sent warning letters to Pfizer’s subsidiary Hospira and Jubilant Life Sciences over good manufacturing practice (GMP) violations at the companies’ facilities in India.   Pfizer   In its warning letter to Pfizer, FDA says that products made at its Hospira facility in Tamil Nadu, India are adulterated as a result of data integrity breaches and laboratory testing shortcomings observed during a week-long inspection la...
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    FDA Approves 18th Biosimilar, 4th for Herceptin

    The US Food and Drug Administration (FDA) late Monday approved the 18 th biosimilar, Pfizer’s Trazimera (trastuzumab-qyyp), which is the fourth approved in the US for Roche’s Herceptin (trastuzumab). Pfizer told Focus it’s working to make Trazimera available to patients as soon as possible but could not provide a specific launch date. The biosimilar is approved for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 ...
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    Industry Groups Call on FDA to Dispel Biosimilar Misinformation

    The Association for Accessible Medicines (AAM) and its Biosimilars Council, as well as the pharmacy benefit manager association, the Pharmaceutical Care Management Association (PCMA), are backing a Pfizer petition that calls on the US Food and Drug Administration (FDA) to do more to counteract untruthful or misleading information on biosimilars. The AAM comment, related to Pfizer’s petition , specifically targets the term “non-medical switching” and the concept of inte...