FDA Designations of Brand and Generic Products

Cincinnati—The designation of a particular drug as a brand or generic drug is determined using the differences among 3 types of FDA drug approval applications, according to a speaker at a Contemporary Issues session at the AMCP meeting. Keith Fisher, MS, RPh, market manager, First Databank, Inc., presented the session, titled FDA Designations of Brand and Generic: Gaining Broader Industry Acceptance?

Mr. Fisher began his presentation by defining the 3 types of applications. The New Drug Application (NDA) process was established by the FDA in 1938 and is required for each new drug entity developed and marketed in the United States. The application demonstrates the safety and efficacy of the drug.

The Abbreviated New Drug Application (ANDA) process was introduced under the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act). The process results in a license to produce and market a duplicate version of a drug that already has FDA approval under an NDA; ANDA demonstrates bioequivalence to a source product.

The third process, Biologic License Application (BLA), is assigned by the FDA to nondrug products such as vaccines and blood products.

Approval designation for each product is represented by the FDA Market Category on the Structured Product Label.

The 2006 introduction of Part D to Medicare coverage defined patient pay in terms of brand and generic and allowed Part D sponsors to place tiers on covered drug products. In July 2007, the Centers for Medicare & Medicaid Services (CMS) provided a definition of generic drug: “For purposes of Part D, what determines whether a drug is a generic drug is the type of application on file for that drug product with the Food and Drug Administration. If a drug product approval is based upon an abbreviated new drug application, that drug is therefore a generic drug.”

Mr. Fisher continued by noting that CMS does not apply the designations of generic and brand for drug coverage under Medicaid. However, there is ongoing discussion in the US Congress that use of the Medicare brand/generic definitions for Medicaid drug coverage might be a way to control escalating costs. Patient pay determinations would also be made consistent across all states.

At present, the FDA is moving from the National Drug Code (NDC) directory (final update, July 2012) to an electronic listing of NDCs (NDC Structure Product Labeling Data Elements File [NSDE]). In a May 14 memo, CMS announced that as of September 1, 2012, no Prescription Drug Event payments would be made unless the drug was listed in the NSDE file.

The session continued with a discussion of biosimilar products. Mr. Fisher provided the FDA definition: “A biosimilar is a biologic product that is highly similar to an already approved biologic product, notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biosimilar and the approved biologic product in terms of the safety, purity, and potency.”

The Patient Protection and Affordable Care Act included a section titled the Biologics Price Competition and Innovation Act of 2009 that defined a biosimilar as a biologic product that is demonstrated to be “highly similar” to, or interchangeable with, a previously approved biologic product. It also authorized the FDA to create an abbreviated approval pathway for biosimilars.

Issued on February 9, 2012, the FDA Draft Guidance on Biosimilars did not include language on how the FDA will name the products, designate biosimilarity to the original biologic product, or define interchangeablilty. The guidance did not indicate when those areas will be addressed, according to Mr. Fisher.

The AMCP position on naming biosimilar products was announced in April. The Academy said the process should limit confusion between patient and providers by using the same government-approved name and/or international nonproprietary name as the reference product and use the manufacturer name, national drug code, and lot numbers to differentiate batches. The FDA should provide clear rules to designate the interchangeable status of a biosimilar, the position statement added.

In summary, Mr. Fisher left attendees with 3 questions: (1) Is CMS making a case to standardize brand and generic definitions? (2) Will biosimilar products be similar to ANDA products? and (3) What contractual issues exist between payers and pharmacies and providers?