Biosimilars or “add-on biologics” have been making the news of late. These are replacements for patented biological drugs developed by biotechnology companies like Genentech and Amgen. Are they the same as generic drugs? No, large molecule biologics products are far more complex than a tablet of aspirin. They can’t be exactly reproduced in the manner of a generic drug which is why they are called, “biosimilars.” How can they be regulated by FDA? That’s a good question that veteran consultant Michael Hamrell discusses in this Guest Commentary. It is a complex and difficult issue and Hamrell does an excellent job of explaining FDA’s Proposal.
User Fees for BiosimilarsThe FDA recently issued it proposed plan for user fees for the new biosimilar products that were authorized under the Healthcare Reform Act in the subsection on Biologics Price Competition and Innovation Act of 2009. This law added a new section (351(k)) to the Public Health Service Act that gives the FDA the authority to approved product biosimilar and interchangeable with a licensed reference biological product. As part of the implementation of the law and regulations for the development of these biosimilar products, the FDA is preparing a proposal for how user fees will be assessed and collected for these products. These fees are proposed to begin with the next reauthorization of the User fee program in FY2013 (October 1, 2012).
Under the initial plan, the user fees for the new biosimilar products will overall be the same as for new biological products. Since FDA expects that marketing application review, preapproval facility inspections, and safety issues will be comparable for 351(k) and 351(a) applications, for the initial 5-year authorization, the Agency proposes to maintain the same PDUFA fee levels for 351(k) marketing applications, manufacturing establishments, and products. However, the Agency proposes to modify this structure to provide resources in the near-term because, as noted in section I of this document, there is no existing inventory of marketed products that would generate fees.One key difference is the planned inclusion of a Biosimilar Product Development Fee, a part of the user fee to be paid upon submission of the IND and annually thereafter while the molecule is under active development that is intended for a single 351(k) application. The initial product development fee is estimated to be around $150,000 per year. Failure to pay the development fee on initial IND submission or annually as required would result in the IND being placed on Full Clinical Hold. The other difference is when the applicant submits the associated 351(k) marketing application, the sum of the previously paid annual Biosimilar Product Development fees would be deducted from the 351(k) marketing application fee.
This is a major difference, at least initially from drug development under the NDA regulations, where no user fee or partial fee is paid during the development phase. The only user fee is paid upon submission of a marketing application. Since the development fee is payable annually during active development, it will be critical that the development program proceed in a logical and efficient manner. Delays in clinical trials, due to GCP problems or other issues will now cost money by extending the IND development phase and having to pay another annual IND development fee.This is still a proposal at this point and the FDA is seeking input and comment on the proposal in order to move forward to finalize a plan. Anyone interested in commenting on the proposal should review the requirement for submitting comments contained in the Federal Register notice regarding the plan (76 FR 27062-27067).
Guest Commentary – Michael Hamrell
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