The Alliance for Patient Access / What's New / ***PRESS RELEASE*** Biologics Prescribers Collaborative Releases New White Paper: The State of Biosimilars Policy

***PRESS RELEASE*** Biologics Prescribers Collaborative Releases New White Paper: The State of Biosimilars Policy

White paper addresses current policy issues impacting biosimilars including naming, interchangeability, and labeling and reimbursement policies 

 WASHINGTON – Today the Biologics Prescribers Collaborative (BPC), a project of the Alliance for Patient Access, released a new white paper, “The State of Biosimilars Policy.” The paper is released in conjunction with a congressional briefing on Capitol Hill this morning where experts will discuss the current biosimilars policy framework and its impact on prescribing, reimbursement and use. The briefing, attended by patient advocates, physician advocates, and congressional and regulatory staff, will be held at 8:30 a.m. in room 562 of the Dirksen Senate Office Building.

The white paper outlines several key topics including naming, interchangeability, indication extrapolation and labeling. Additionally, the white paper addresses other policy issues including CMS reimbursement.

Read the full white paper HERE.

THE STATE OF BIOSIMILARS POLICY WHITE PAPER HIGHLIGHTS

Enter the biosimilar, which is what its name implies – a biologic that is “similar” to another biologic drug already on the market…These medicines are an important new category of therapy because they have the potential to increase access to biologic therapies and provide cost savings to patients and the health care system. In the United States alone, the cost savings from using biosimilars in comparison to the original biologic are projected to be between $40 and $250 billion over the next 10 years…

For an individual patient, a distinct name facilitates the accuracy of the medical record. For evaluating the effect of the drug among patient populations as a whole, distinguishable names allow data identification to be associated with a given drug name instantaneously…

An interchangeable biological product may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product…

BPC supports FDA’s suggestion, per its recent guidance, that clinical studies should demonstrate multiple switches back and forth between the biologic reference product and the proposed biosimilar, not just one switch from the reference product to the biosimilar.  Further, using at least two exposure periods to each drug best simulates a patient’s experience with changing formularies…

Extrapolation is an essential component of an approval process designed to bring safe and affordable biosimilars to patients. Therefore, FDA must ensure that any extrapolation to additional indications is rigorously conducted, especially where the mechanism of action differs…   

Explicit labeling and transparent communications are needed to ensure the appropriate use of biosimilars in accordance with FDA direction and to discourage commercial insurers, PBMs, specialty pharmacies, and Medicare carriers from adopting and enacting non-medical switching practices as part of formulary designs that substitute a biosimilar for an innovator in patients already on therapy…

The current CMS J-Code Proposal that provides for one payment level appears to take a generic medicine payment approach to medicines that are not generic by definition. Biologic and biosimilar medicines are not identical to each other or manufactured using the same processes. It is inappropriate to group their payment in a competition solely based on price…

Brian Kennedy, Executive Director of the Alliance for Patient Access, will lead this morning’s 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 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].

 

Resources

Biologics Prescribers Collaborative                                               http://biologicsprescribers.org

Alliance for Patient Access                                                           http://allianceforpatientaccess.org

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The Alliance for Patient Access is a national network of physicians dedicated to ensuring patient access to approved therapies and appropriate clinical care.
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