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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Last week, FDA Commissioner Scott Gottlieb announced new draft guidance on risk evaluation and mitigation strategies (REMS) programs. The draft guidance provides for a single shared Drug Master File...
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FDA BsUFA Goals Letter Outlines Plans for Guidance, Pushes Back Timeline on...
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...
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FDA to Issue Draft Guidance on Interchangeability by End of Year
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...
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Regulators Highlight Differing International Biosimilar Regulations;...
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...
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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...
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Goodwin Publishes Biosimilars Patent Litigation Update, Biosimilars...
Goodwin announced today the release of its 2016 BPCIA Litigation Update and Thinking of Investing In a Biosimilars Product? The 2016 BPCIA Litigation Update recaps a busy year in the legal world of...
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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...
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FDA Seeks Comments on Evaluation of Proposed New Model for Reviewing BLAs
The FDA announced that it is soliciting public comments on the statement of work for the assessment of its proposed new model for the review of original Biologics License Applications submitted under...
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FDA Grants Priority Review to Merck’s Application for KEYTRUDA...
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...
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Regulatory Update on Alvotech’s AVT02, a High-Concentration Interchangeable...
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)....
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