Search Results: Regulatory Guidances

Regulatory Update on Alvotech’s AVT02, a High-Concentration Interchangeable Adalimumab Biosimilar

On September 20, Alvotech announced that FDA has accepted the resubmission of its Biologics License Application (BLA) for AVT02, a high concentration, interchangeable biosimilar to HUMIRA (adalimumab). FDA has set a Biosimilar User Fee Act (BsUFA) goal date for approval of the resubmitted AVT02 BLA of February 24, 2024.  As…

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FDA Grants Priority Review to Merck’s Application for KEYTRUDA (pembrolizumab) as Part of Treatment for Early-Stage Cervical Cancer

On September 20, Merck announced that the U.S. Food and Drug Administration (FDA) granted priority review status to Merck’s supplemental Biologics License Application (sBLA) seeking approval for its anti-PD-1 therapy KEYTRUDA (pembrolizumab) in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy, as a treatment for newly…

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FDA Announces New Draft REMS Guidance

Last week, FDA Commissioner Scott Gottlieb announced new draft guidance on risk evaluation and mitigation strategies (REMS) programs. The draft guidance provides for a single shared Drug Master File submission for all manufacturers of the same drug, which eliminates duplicative paperwork. This draft guidance is part of the FDA’s new two-pronged…

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FDA Releases Biosimilar Naming Guidance

FDA just released a final Guidance for Industry, “Nonproprietary Naming of Biological Products.”  The guidance provides that naming for originator biological products, related biological products, and biosimilars should include a “core name” followed by a four-letter suffix.  The core name typically will be the USAN Council name for the Reference Product (RP)….

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Guidance on Biosimilar Submission Requirements in Canada

Health Canada, the federal regulatory authority that evaluates the safety, efficacy, and quality of drugs available in Canada recently released a revised Guidance Document on Information and Submission Requirements for Biosimilar Drugs (“Guidance”).  The Biologics and Genetic Therapies Directorate (BGTD) within the Health Products and Food Branch of Health Canada is the…

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Regulators Highlight Differing International Biosimilar Regulations; Interchangeability Guidance May Slip to 2017

Bloomberg BNA reported that a panel of regulators at the DIA 2016 Biosimilar Conference in Washington highlighted the differences among biosimilar regulations internationally and the ongoing changes as countries revise their biosimilar guidances. For instance, in Canada, biosimilars are regulated as new biologics as opposed to the U.S.’s abbreviated pathways…

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FDA to Issue Draft Guidance on Interchangeability by End of Year

gloved hand withdraws drug solution with syringe

Last Thursday, October 20, the FDA held a scheduled public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA).  The FDA heard from a wide spectrum of stakeholders, including patient/public health advocates, healthcare professionals, and industry representatives.  As we previously reported, the FDA had committed to publishing a draft…

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FDA BsUFA Goals Letter Outlines Plans for Guidance, Pushes Back Timeline on Interchangeability Guidance

FDA has published its performance goals and procedures (commonly referred to as FDA’s “goals letter” or “commitment letter”) for the Biosimilar Biological Product User Fee Act (“BsUFA”) reauthorization for fiscal years 2018 – 2022, ahead of its upcoming public meeting on October 20, 2016 to discuss FDA’s proposed recommendations for the BsUFA reauthorization….

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