Earlier this month, the House of Representatives passed H.R. 2430: FDA Reauthorization Act of 2017 (FDARA) by voice vote. The FDARA seeks, among other things, to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar…
Last week, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule regarding payment policies. Among other things, the proposed rule included a request for comment on the policy for biosimilar reimbursement. A fact sheet prepared by CMS explains that the existing policy, finalized in 2016, provided that…
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 section 351(k) of the Public Health Service Act. Last fall, we reported on the FDA’s performance goals for the reauthorization…
Yesterday, RAPS reported that the FDA is expecting the first interchangeable biosimilars to become available in the U.S. market within the next two years. Interchangeable biosimilars are those that “can be expected to produce the same clinical result as the reference product in any given patient.” In states with automatic substitution…
On May 11, 2017, Scott Gottlieb was sworn in as the 23rd Commissioner of the U.S. Food & Drug Administration. Before his confirmation, Gottlieb was vocal about his disapproval of the FDA’s “well-established” attitude: an excessive desire for certainty, which he says “is impeding the availability of safe, effective drugs…
Today, the FDA announced the availability of a draft guidance on biosimilar interchangeability, entitled “Considerations in Demonstrating Interchangeability With a Reference Product,” which is currently available on FDA’s website. The official announcement is scheduled to be published in the Federal Register tomorrow, January 18, 2017. This guidance provides an overview…
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)….
The FDA issued a new Guidance today, titled “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.” The Guidance is intended to “assist sponsors with the design and use of clinical pharmacology studies to support a decision that a proposed therapeutic biological product is biosimilar to its…
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…
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….