Biosimilar Drugs: The Unanswered Questions of Labeling and Interchangeability

Today’s guest post comes from Kay Morgan, Vice President of Drug Products & Industry Standards Clinical Solutions at Elsevier.

Kay discusses the complexities of identifying and labeling biosimilar drugs. She also explains the FDA’s existing draft guidelines and the market’s reaction to those guidelines.

For more background on biosimilars and drug pricing, read Kay’s article below and download Elsevier’s free white paper: Rising Drug Prices: Impact of Biosimilars.


Biosimilar Drugs: The Unanswered Questions of Labeling and Interchangeability
By Kay Morgan, Vice President of Drug Products & Industry Standards Clinical Solutions at Elsevier

As many specialty blockbuster drugs lose patent protection over the next decade—and as the push toward affordable healthcare intensifies—opportunities for biosimilar drugs are gaining momentum. According to the Federal Trade Commission (FTC), biosimilars could save the U.S. health system $250 billion through 2022.

The Biologics Price Competition and Innovation Act (BPCIA) of 2009 created an abbreviated licensure pathway for biosimilar approval. Even though biosimilar drugs are required to meet Food and Drug Administration’s (FDA) standards of safety and efficacy, the pathway is intended to demonstrate a product’s biosimilarity or interchangeability with an FDA-licensed biological product known as a reference product that has been approved under the 351k of the Public Health Services Act.

Due to the complex nature of biosimilar drugs, the BPCIA opened the door for many questions relating to interchangeability, questions that remain unanswered. Among them: Can physicians, pharmacists, health systems and other stakeholders change a referenced biologic drug for a biosimilar drug? The answer is not that simple.

The key to interchangeability is the biosimilar drug must match the reference drug in terms of efficacy and risk of adverse reactions. The FDA created two biosimilar pathways in the BPCIA:

1. 351 (k) (2) (A) Not interchangeable.
2. 351 (k) (2) (B) Interchangeable.

The process for establishing interchangeability is difficult at best. Biosimilars have mixed and complicated structures that can be sensitive to environmental factors and include other ingredients not found in the reference product. Generic drugs must contain active ingredients that are identical to those of the branded drug. Does it matter that biosimilars are not identical to the biologic drug? The questions continue: What will the FDA require to prove interchangeability? How long will the interchangeability approval process take? Will pharmacists have to contact physicians before switching to biosimilars?

Meanwhile, state legislators are passing biosimilar bills that will allow pharmacists to substitute biosimilars in cases where the FDA has determined the drug interchangeable, even though there are no biosimilar drugs deemed interchangeable currently on the market. Some pharmacy groups oppose the legislation and feel it will stifle competition by requiring physician notification and time-consuming record-keeping.

Naming Conventions

The naming conventions of biosimilar drugs pose additional questions and challenges for interchangeability. Many stakeholders, for example, have criticized last year’s labeling package for Zarxio (filgrastim-sndz), the first biosimilar approved in the U.S. The labeling of Zarxio was essentially identical to the labeling of Amgen’s Neupogen, the reference filgrastim product.

The U.S. Food and Drug Administration (FDA) originally released draft guidelines in August 2015 recommending labeling similar to how generic drugs are labeled. The biosimilar should share the name of the reference product and should include an FDA-designated suffix to allow for better identification.

The Federal Trade Commission (FTC) went on record in opposition citing that it could result in physicians and prescribers incorrectly believing that biosimilars’ drug substances differ in a clinically meaningful way from their reference product and could hinder competition.

Biologic drug manufacturer, AbbVie filed a citizen’s petition with the FDA citing that biosimilars should not be treated the same as generic drugs because the statutory standard for FDA approval is that a biosimilar be “highly similar” to the reference product and have no “clinically meaningful” differences. This approval standard differs from that of generic drugs per the Hatch-Waxman Act. AbbVie contends that these facts “lead to the conclusion that FDA should not find a biosimilar biological product interchangeable with a reference product unless the agency has found the two products interchangeable for every condition of use for which the reference product is licensed.”

In March 2016, FDA revised its draft guidance, taking middle ground by not requiring biosimilar labels to be identical to their reference product. Specifically, the FDA says:

“FDA’s finding of safety and effectiveness for the reference product…may be relied upon to provide health care practitioners with the essential scientific information needed to facilitate prescribing decision for the proposed biosimiar product’s labeling conditions of use (e.g., indication(s), dosing regimens(s)).”

FDA’s guidance also explains that biosimilar labels should only include biosimilar-specific information that is “necessary to inform safe and effective use of the product.” It also states that biosimilar manufacturers are responsible for updating the labeling if new safety or risk information emerges.

The impact of biosimilars on drug prices and healthcare will continue to play out as more biosimilars enter the U.S. market and as the FDA moves closer to a final ruling.

Read Elsevier’s White Paper, Rising Drug Prices: Impact of Biosimilars to learn more.

Elsevier is the industry leader for the most current, accurate and reliable drug product and pricing information. Elsevier’s Gold Standard Drug Database includes all drug price types, including AWP, NADAC, state MACs, ACA-FUL and Predictive Acquisition Cost (PAC), the most reliable and current acquisition cost-based drug price solution.

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