NCPDP Provides Guidance to FDA Panel at Historic FDA Meeting on Biosimilars

Share Article

Today, NCPDP addressed the FDA, CDER and ODAC meeting that met to review and make a recommendation on what may be the first biosimilar to receive FDA approval in the U.S., and potentially develop a process for expedited approval of biosimilars. NCPDP spoke on the possible patient safety risks associated with deviating from using a different non-proprietary name than the innovator product for biosimilars.

NCPDP

National Council for Prescription Drug Programs

By maintaining a high integrity, unambiguous standards-driven system, we can reinforce existing naming standards designed to support the safe and effective use of all medicines.

Today, NCPDP Senior Vice President, Standards and Industry Information Technology, John Klimek, R.Ph., addressed the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) and Oncologic Drugs Advisory Committee (ODAC) meeting that met to review and make a recommendation on what may be the first biosimilar to receive FDA approval in the U.S., and potentially develop a process for expedited approval of biosimilars. NCPDP spoke on the possible patient safety risks associated with deviating from using a different non-proprietary name than the innovator product for biosimilars.

NCPDP strongly urged the FDA to give biosimilars the same nonproprietary names as the innovator product to support the safe and effective use of biosimilars, citing how the drug compendia compile data, which is then interfaced for specific downstream needs –in retail pharmacy, hospital, or other healthcare settings.

Applying different names for the same biological drug ingredients introduces confusion and unnecessary complexity; conflicts with normal pharmacy practice - employing an electronic database to recognize products by identifiers; is unnecessary for product recall or other patient safety considerations; and undervalues the ability of existing systems (NDC- and lot-based recalls) and new regulatory structures (track and trace) to provide adequate safeguards. It will also affect clinician decision-making, the ability to identify therapeutic alternatives, and put patient safety at risk.

“By maintaining a high integrity, unambiguous standards-driven system, we can reinforce existing naming standards designed to support the safe and effective use of all medicines – including biosimilars - in the interests of all stakeholders, but most importantly, patients,” explained Klimek.

For more information on NCPDP, visit http://www.ncpdp.org.

About NCPDP
Founded in 1977, NCPDP is a not-for-profit, ANSI-accredited, Standards Development Organization with 1,600 members representing virtually every sector of the pharmacy services industry. Our diverse membership provides leadership and healthcare business solutions through education and standards, created using the consensus building process. NCPDP has been named in federal legislation, including HIPAA, MMA, and HITECH. NCPDP members have created standards such as the Telecommunication Standard and Batch Standard, the SCRIPT Standard for ePrescribing, the Manufacturers Rebate Standard and more to improve communication within the pharmacy industry. Our data products include dataQ®, a robust database of information on more than 76,000 pharmacies, and HCIdea®, an innovative prescriber database that provides continually updated information on more than two million prescribers. NCPDP's RxReconn® is a legislative tracking product for real-time monitoring of pharmacy-related state and national legislative and regulatory activity. For more information about NCPDP Standards, Data Services, Products, Educational Programs and Work Group meetings, go online at http://www.ncpdp.org or call (480) 477-1000.

###

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Janet Cabibbo
NCPDP
+1 480-477-1000 Ext: 104
Email >

Maggie Bruce
NCPDP
480-477-1000 144
Email >