Congressional briefing will explore naming, interchangeability, and labeling; reimbursement policies and the Biosimilar User Fee Act
WASHINGTON – On Thursday, April 27 the Biologics Prescribers Collaborative (BPC), a project of the Alliance for Patient Access, will host a congressional briefing on Capitol Hill to discuss the current biosimilars policy framework and its impact on prescribing, reimbursement, and use. The discussion will also highlight a new white paper from BPC, “State of Biosimilars 2017.” The briefing, attended by patient advocates, physician advocates, congressional and regulatory staff, will be held at 8:30 a.m. in room 562 of the Dirksen Senate Office Building.
Brian Kennedy, Executive Director of the Alliance for Patient Access, will lead the briefing, which also features perspectives from Angus Worthing, MD, American College of Rheumatology, Steven Grossman, JD, FDA regulatory expert, and Stephen Marmaras, Director of State and National Advocacy, Global Health Living Foundation.
The white paper, which will be released in full next week prior to the briefing, calls for:
- Naming policies that provide sufficient information to track and trace adverse events.
- Labeling that is transparent which would include:
o a statement of whether the biosimilar is interchangeable with the reference product and/or other biosimilars on the market.
o either a summary of the full clinical data submitted in support of biosimilar approval or a hyperlink to the FDA’s summary basis of approval, to include where biosimilar properties, structure and function differ from the reference product.
- A requirement for applicants to seek approval of a biosimilar as interchangeable for all the reference product’s conditions of use.
- Case by case extrapolation determinations based on extensive analytic and clinical data.
- Unique J-Codes that will support innovation and access.
- BsUFA reauthorization that provides FDA the resources it needs to support increased staff capacity for the development and review of biosimilar-related regulations.
The Biologics Prescribers Collaborative represents medical societies whose members regularly prescribe biological medicines. The group educates and makes comment on major policy issues respecting biologics and biosimilars. The Biologics Prescribers Collaborative aims to ensure that sound policies are in place to ensure prescriber and patient confidence in all biologic therapies, including biosimilars.
The briefing is open to the press. Press interested in attending should RSVP to Susan Hepworth at [email protected].
Biologics Prescribers Collaborative http://biologicsprescribers.org
Alliance for Patient Access http://allianceforpatientaccess.org