Next Tuesday (December 5) between 1:00-2:30pm (EST), FDA’s Division of Drug Information is presenting a webinar titled an “Overview of the Regulatory Framework and the Development and Approval of Biosimilar Products in the U.S.” The webinar will provide an overview of the regulatory framework for biosimilar products, “including a background,…
Last week, FDA Commissioner Scott Gottlieb announced new draft guidance on risk evaluation and mitigation strategies (REMS) programs. The draft guidance provides for a single shared Drug Master File submission for all manufacturers of the same drug, which eliminates duplicative paperwork. This draft guidance is part of the FDA’s new two-pronged…
On October 23, 2017, FDA announced the release of new educational materials to help health care professionals understand what biosimilars are and how they are approved. The materials include four fact sheets and graphics that provide definitions for relevant terminology, describe the biosimilar approval process, and explain the benefits of biosimilars. FDA also created social media posts for external…
As we posted previously, Biocon and Mylan are jointly developing a pegfilgrastim biosimilar, and have sought marketing authorization in the US. On October 10, Biocon reported that the FDA issued a Complete Response Letter (CRL). According to Biocon, the CRL relates to “pending update of the BLA with certain CMC data from…
Last week, the FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2018 federal fiscal year, which runs from October 2017 through September 2018. The FDA determined these rates pursuant to the Food and Drug Administration Reauthorization Act (FDARA), signed into law on August 18, 2017. Among other things,…
The White House released a statement of administration policy on July 12 in response to the House of Representatives passing H.R. 2430, a bill that would reauthorize the FDA’s user fee programs, including FDA’s biosimilar user fees. The White House statement calls for “Congress to provide for 100 percent user…
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…