Tuesday Mar 05, 2024

505b2 Pathway: Ghost Generics

The 1984 Hatch-Waxman Act codified the 505(b)(2) drug approval pathway and allowed the use of studies from a previously approved drug. To be clear, medications approved via this pathway are not generic molecules of the reference listed drug. They may have similar clinical effects and roles in therapy, but they also bring challenges. Dr. Tyler Wood, System Director of Pharmacy Oncology and Biosimilars, and Pharmacy Executive Director, Carolyn Liptak at Vizient, join Gretchen Brummel, Pharmacy Executive Director in the Vizient Center for Pharmacy Practice Excellence and your program host to give an early look.


Guest speakers: 
Tyler Wood, PharmD, BCBBS
System Director, Pharmacy Oncology and Biosimilars 
Providence St. Joseph Health


Carolyn Liptak, MBA, BSPharm
Pharmacy Executive Director 


Gretchen Brummel, PharmD, BCPS 
Pharmacy Executive Director 
Vizient Center for Pharmacy Practice Excellence


Show Notes: 

[00:55-01:34] Dr. Tyler Wood background information 

[01:35-03:09] How the 505(b)(2) pathway is intended to work

[03:10-04:32] Comparisons can we draw from the biologics approval process

[04:33-05:53] What the FDA says about which pathway to use

[05:54-07:05] What's changed recently in the approval process

[07:06-08:09] Can a 505(b)(2) product be rated as a generic equivalent?

[08:10 -09:07] How CMS changes are impacting management

[09:08-11:23] What our providers can do to plan and act to address these issues

[11:24-12:27] What’s most concerning moving forward


Links | Resources: 

Applications Covered by 505(b)(2)

Hospital Outpatient Prospective Payment System: January 2024 Update

MLN Matters® Articles Sign-up

CMS.gov ASP Pricing Files

CMS.gov What's a MAC

Drugs@FDA: FDA-Approved Drugs

FDA: Overview of the 505(b)(2) Regulatory Pathway for New Drug Applications

HCPCS Level II Coding for 505(b)(2)-Approved Drugs or Biologicals – Frequently Asked Questions


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