On April 30, 2015, Senators on the Health Education Labor and Pensions Committee (HELP) urged FDA to provide additional guidance on “important issues relating to the review and approval of license applications for biosimilar products such as naming, interchangeability, and production of patent information. Senator Lamar Alexander (R-Tenn.) today led a group of nine Republicans on HELP signing the letter: Sens. Michael Enzi (R-Wyo.), Richard Burr (R-N.C.), Johnny Isakson (R-Ga.), Mark Kirk (R-Ill.), Orrin Hatch (R-Utah), Pat Roberts (R-Kan.), Sen. Susan Collins (R-Maine), and Bill Cassidy, M.D. (R-La.).
The Senators expressed concern that much of FDA’s guidance remains in draft form and leaves many critical issues unresolved. For example, on the one hand, FDA has approved a biosimilar product with a “placeholder” name, but, on the other hand, FDA has not issued guidance about nonproprietary naming. In particular, the Senators appeared to question how FDA has been handling their review of biosimilar applications when much of the guidance is unwritten or in draft form. In addition to requesting that FDA prioritize publication of final guidance on issues identified in the letter, the Senators asked FDA to improve its transparency of biosimilar review and the approval process. Specifically, the Senators requested that FDA answer the following questions by May 22, 2015:
- What is a “placeholder” nonproprietary name, and what is FDA’s legal authority to issue and/or to change such a name? How do “placeholder” nonproprietary names differ from other forms of nonproprietary names, including (a) established names under Section 505(e) of the federal Food, Drug, and Cosmetic Act (FDCA); (b) interim established names as recognized under Novartis Pharmaceuticals Corp. v. Leavitt; and (c) proper names under Section 352(a)(1)(B)(i) of the Public Health Service Act (PHSA)?
- What is the process for changing a “placeholder” nonproprietary name, and what is the estimated economic impact of such a change? In the event a “placeholder” nonproprietary name changes, what steps would FDA and the manufacturer take to avoid potential confusion among patients and public health professionals and to ensure that no misbranded product is sold on the market?
- What guidelines have FDA staff members been following in reviewing biosimilar applications? Please provide copies of all written guidelines provided to staff regarding such review since February 2012. Has any staff member been instructed either to follow, or not to follow, recommendations in any of the draft guidance documents that FDA has published regarding biosimilarity or interchangeability (including documents that were in draft form at the time of review but have since been finalized)?
- Under what circumstances does FDA consider it necessary for a biosimilar product to disclose in its labeling that it has or has not been found interchangeable with its reference product (or other products found biosimilar to the same reference product)? Why did FDA (a) withdraw the draft guidance it published on this issue and (b) approve labeling for a biosimilar product that contains no such disclosure?
- What guidance documents regarding biosimilar or interchangeable products does FDA currently intend to publish, and on what schedule? Please provide: (a) the schedule on which FDA currently intends to finalize or withdraw each draft guidance document that FDA has published on these topics, if FDA has not provided it already; and (b) a list of additional guidance documents that FDA currently intends to publish on these topics, including the anticipated timeframe for publication and whether FDA intends to publish the document in draft or final form.
- Why has FDA declined to provide guidance regarding whether the information exchange provisions of Section 351(l) of the PHSA are mandatory? If FDA is not providing such guidance because of pending litigation between private parties, please provide FDA’s position on the circumstances under which private litigation precludes FDA from issuing guidance regarding statutes within its jurisdiction.
- How is FDA communicating with and educating patients regarding biosimilars, including on issues such as biosimilarity, extrapolation, and interchangeability?
We will continue to keep you posted as more information about this letter becomes available.