FDA Releases Draft Guidance on Labeling of Biosimilars

April 1, 2016
Caroline Hroncich

Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.

The draft guidance states information concerning a clinical study of a biosimilar should only be included if it is necessary to demonstrate the safety and efficacy of the drug.

FDA released a highly anticipated draft guidance on the labeling of biosimilar products on March 31, 2016. The guidance states that information concerning a clinical study of a biosimilar should only be included in the products labeling if it is “necessary to inform safe and effective use by a health care practitioner.” This will only be required in certain situations, FDA wrote, since studies done on biosimilars are generally meant to show there are no clinically meaningful differences between the biosimilar and the reference biologic, and may not be relevant to prescribers.

FDA recommends that information on a biosimilar product label should incorporate the relevant data from reference product’s labeling with “product-specific modifications.” These modifications may differ depending on the indications for which the biosimilar is approved. Information related to administration, preparation, storage, or safety should also be included in the biosimilar label if different from the reference product, wrote FDA.

FDA notes the biosimilar product name should only be used on the label if the text is referring solely to the biosimilar. When clinical studies or information related to the reference product is described in the label, the reference product’s name should be used. FDA writes when the risk associated with taking a biosimilar is also relevant for the reference product, “it would be appropriate to use the core name of the reference product followed by the word ‘products.’”

In an article on FDA’s website, Leah Christl, PhD, associate director for Therapeutic Biologics and lead of the Therapeutic Biologics and Biosimilars Staff in the Office of New Drugs, discusses FDA’s reasoning behind the guidance. Christl writes that including comparative clinical data in biosimilar product labeling would be “confusing or potentially misleading to health care providers.” While this data may be important for determining biosimilarity, it may not be applicable when prescribing the drug, she said.

“However, I want to point out that these comparative data generally will be available to the public,” Christl writes. “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.”

In an investor report from Evercore ISI discussing the guidance, Umer Raffat, senior analyst of equity research, specialty pharmaceuticals, notes, “pharma sponsors had asked FDA to move away from the type of labeling format it had used for the first biosimilar, Sandoz’s Zarxio,” which was labeled similarly to generic drugs. Raffat says sponsors encourage FDA to describe the clinical data for the biosimilar on the label, and to “also describe differences [versus] the brand’s data.”

In May 2015, multiple physician groups submitted an open letter to FDA on biosimilar labeling, urging the agency to take into consideration the needs of physicians. The groups cited the “lack of prescriber education” on biosimilars, saying physicians may mistake an identical label as a representation of interchangeability between the biosimilar and reference product.

Abbvie submitted a Citizen Petition to FDA in August 2015 discussing FDA policy on biosimilar naming. The biopharmaceutical company was concerned with an explanation FDA gave the Senate Committee on Health, Education, Labor, and Pensions (HELP Committee) on interchangeability in biosimilar labels. In the letter, AbbVie expressed concern that FDA told the HELP Committee information on interchangeability could be found in The Purple Book, and did not need to be included in the biosimilar product label. The company also said it would be misleading to include study information from another drug in a biosimlar label without acknowledging the studies were not done on the biosimilar itself.

It is important to note that FDA did not make any definitive statements about interchangeability in new draft guidance. The agency writes, “FDA continues to consider the types of data and information that would support a demonstration that a biological product is interchangeable with a reference product.” FDA says it will cover interchangeability recommendations in a future guidance.

Source: FDA