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From our perspective: Biosimilar product labeling

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Updated on July 18, 2018 from its original version.

Leah Christl, Ph.D., Associate Director for Therapeutic Biologics and director of the Therapeutic Biologics and Biosimilars Staff in the Office of New Drugs, discusses FDA’s approach to biosimilar product labeling.


Leah Christl, PhD

Therapeutic biological products

Biological products are regulated by the U.S. Food and Drug Administration (FDA) and are used to diagnose, prevent, treat, and cure diseases and medical conditions. Biological products are a diverse category of products and are generally large, complex molecules. These products may be produced through biotechnology in a living system, such as a microorganism, plant cell, or animal cell, and are often more difficult to characterize than small molecule drugs. There are many types of biological products approved for use in the United States, including therapeutic proteins (such as filgrastim), monoclonal antibodies (such as adalimumab), and vaccines (such as those for influenza and tetanus).

Introducing biosimilars to the U.S. market

Through the Biologics Price Competition and Innovation Act (BPCI Act) of 2009, Congress created an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved biological product, called the reference product. This pathway was established as a way to provide more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition.

Approved biosimilar products have been determined to be highly similar to an FDA-approved reference product and demonstrated to have no clinically meaningful differences from the reference product in terms of safety, purity and potency (e.g., safety and effectiveness).

Demonstrating biosimilarity

Manufacturers of proposed biosimilar products generate an array of data comparing a proposed biosimilar product to the FDA-approved reference product in order to demonstrate biosimilarity. The comparative data are generated in a step-wise fashion that begins with a foundation of detailed analytical (structural and functional) characterization of the products, moving on to animal studies if necessary, and then to comparative clinical studies.

The goal of a biosimilar development program is to demonstrate biosimilarity between the proposed product and the reference product, not to independently establish the safety and effectiveness of the proposed product. Consequently, a biosimilar product that is shown to be highly similar to an FDA-approved reference product may rely on FDA’s previous determination of the reference product’s safety and effectiveness, rather than generate a full profile of product-specific nonclinical and clinical data, to support approval. This generally means that biosimilar manufacturers do not need to conduct as many expensive and lengthy clinical trials, potentially leading to faster access to these products, additional therapeutic options, and reduced costs for patients.

Prescription Drug Labeling

Before I delve further into our approach to biosimilar labeling, let me take a step back to first explain the value of labeling. Prescription drug product labeling communicates the product’s safety and effectiveness information to health care providers. Labeling summarizes the key scientific information that health care providers need to assess a therapeutic product’s risk-benefit profile and decide if the product is appropriate for use by their patient.

In early 2006, FDA finalized its regulations on the content and format of labeling for prescription drug products, including biological products. The final labeling regulations, commonly known as the Physician Labeling Rule (PLR), are designed to ensure that health care providers have clear and concise information in prescription drug labeling, and to make it easier for health care providers to use labeling to make their prescribing decisions. Labeling includes three sections: Highlights of Prescribing Information, a Table of Contents, and the Full Prescribing Information.

In 2014, FDA updated its regulations on labeling information geared toward pregnant women, lactating women and individuals of reproductive potential through the Pregnancy and Lactation Labeling Rule.

Biosimilar labeling specifics

To address biosimilar labeling in particular, we have issued detailed recommendations to industry in the “Labeling for Biosimilar Products” final guidance. One of the first items health care professionals may notice in the Highlights section is the addition of a “Biosimilarity Statement” describing the biosimilar product’s relationship to its reference product.

For the Full Prescribing Information, we recommend that biosimilar product labeling incorporates relevant data and information from the FDA-approved labeling for the reference product, along with any appropriate modifications specific to the biosimilar product. Note that a biosimilar product is not required to have the same labeling as its reference product, and so biosimilar product labeling may differ from the reference product labeling for a variety of reasons. For example, a biosimilar applicant may seek licensure for fewer than all of the indications for which the reference product is approved, and this difference would be reflected in product labeling.

Utility of comparative data

While we recommend that biosimilar labeling include biosimilar product-specific data necessary to inform safe and effective use of the product, we generally do not recommend that comparative data supporting the demonstration of biosimilarity be included in biosimilar product labeling. We’ve taken this approach to avoid potential confusion or misinterpretation of the comparative data.

As I mentioned, rather than essentially repeat the reference product’s demonstration of safety or effectiveness, comparative clinical studies are intended to demonstrate that there are no clinically meaningful differences between the proposed biosimilar product and the reference product. Indeed, comparative clinical studies in a biosimilar development program may use endpoints or study populations that are different from those used to support approval of the reference product.

Due to the potential for differences in clinical study parameters, we think that including comparative clinical data in biosimilar product labeling would be confusing or even potentially misleading to health care providers. Ultimately, the comparative data are useful for the FDA to make a decision about biosimilarity, but are not likely to be relevant to a health care provider’s prescribing considerations. 

However, I want to point out that these comparative data generally will be available to the public. Health care providers and others who want to delve more deeply into the product-specific data supporting a demonstration of biosimilarity, including the comparative clinical data, may find this information in FDA’s product reviews, on our Drugs@FDA website.

Next steps for biosimilars

We think that our approach to biosimilar labeling will be truly beneficial to health care providers as they consider prescribing options and the risk-benefit decisions for their patients. FDA issued the draft guidance in April 2016, and we received a range of comments from various stakeholder communities, including industry, health care providers, and patients. We reviewed and considered all of the comments before we finalized guidance on this topic.

Biosimilars have the potential to offer significant cost savings for patients and the health care system. While they are relatively new products in FDA’s regulatory landscape, we are committed to encouraging innovation and competition among biologics, and facilitating the development of biosimilars. We are currently working to develop policies and actions that improve the efficiency of FDA’s review of biosimilar applications and increase regulatory certainty for biosimilar manufacturers and other stakeholders. See the Biosimilar Action Plan for more details. The FDA also recently launched an education campaign to help increase understanding of biosimilar and interchangeable products among health care professionals. We want health care providers to understand that FDA undertakes a comprehensive evaluation to ensure that biosimilar and interchangeable products meet the respective rigorous standard for approval. All the education materials, including fact sheets, videos, and other information about biosimilar products, can be found at www.fda.gov/biosimilars.

FDA will continue to build upon its experience in reviewing and approving biosimilar products to ensure that new, safe and effective health care options become available for patients.


Dr. Christl is the Director for Therapeutic Biologics in the Office of New Drugs (OND) in the FDA's Center for Drug Evaluation and Research. Dr. Christl also is the director of the Therapeutic Biologics and Biosimilars Staff (TBBS) in OND. TBBS is responsible for ensuring consistency in the scientific and regulatory approach and advice to sponsors regarding development programs for proposed biosimilar products and related issues regarding development programs for therapeutic biologics. Prior to joining the FDA, Dr. Christl received her Ph.D. in Molecular and Cellular Biology and Pathobiology – Marine Biomedicine and Environmental Science from the Medical University of South Carolina in Charleston. She also spent two years at the University of South Carolina as an Associate Research Professor.




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