(This story was updated at 11:15 p.m. ET.)
Biologic manufacturers may not be pleased with the long-awaited biosimilar labeling guidelines released Thursday by the Food and Drug Administration.
The agency is recommending that labeling for biosimilars use the clinical data gathered by the product the biosimilar is intended to emulate. Regulators would also allow biosimilar labels to state that the product is biosimilar to the reference product but has product-specific modifications.
Biosimilars are derived from living organisms and therefore may not be identical to brand-name drugs.
Federal regulators are likely trying to simplify physicians' understanding of the products' efficacy and safety by allowing biosimilars to use the clinical data that supported the reference product's approval. By definition, a biosimilar product has no clinically meaningful difference in terms of safety, purity and potency.
Although the FDA notes that the labeling does not need to be identical to information based on the reference product, manufacturers of biologics will likely take issue with competitors using their data for a product that is not exactly the same. A spokesman for the Biotechnology Industry Organization, which represents biologics manufacturers and other biotech companies, said the group was currently reviewing the guidance and not yet in a position to comment.
Siegmund Gutman, chair of the life sciences patent practice at law firm Proskauer, said the FDA's moves in the biosimilar space have been similar to how the agency established regulations for the generic drug market. Generic drugs typically have identical labels to their name-brand counterpart, as required by laws that ensure patient safety.
“It's not a completely unprecedented issue,” Gutman said. “People may question whether these drugs should be treated differently…but I think it's a similar situation.”
Courts have found that generic manufacturers can't be found liable for issues in identical labeling used from a reference product, Gutman said. That may be why the FDA did not require labeling to be identical, and there may be room for future legislation regarding that issue for biosimilars, he said.
“From the FDA standpoint, they want to take this on a case-by-case basis,” Gutman said. “If we decide that a biosimilar product is safe and effective for use in a particular indication, that there shouldn't be (a difference)…that's the point of the FDA approval process.”
The "appropriate product-specific modifications” on the biosimilar labels can describe differing indications of use and dosing regimens, the FDA notes. But information from the clinical study of a proposed biosimilar should be used only when it informs the safe and effective use of the product by a provider.
The agency points out that most clinical studies supporting a biosimilar product would demonstrate its biosimilarity rather than its own safety and efficacy. This kind of information isn't likely to be relevant for provider instruction and could cause confusion, regulators say.
“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 healthcare providers,” Leah Christl, the FDA's associate director for therapeutic biologics, wrote in a blog post. “Ultimately, the comparative data are useful for the FDA to make a decision about biosimilarity, but are not likely to be relevant to a healthcare provider's prescribing considerations.”
The guidance also explained that the biosimilar's name should be used in labeling information that describes product-specific indications or risks, but the reference product name should be used in sections that include that product's data, which could report adverse reactions found in clinical trials. If the biosimilar has a proprietary name, the agency recommends using it.
Christl wrote that the agency is reviewing comments received on its draft guidance on nonproperiatary naming of biosimilar products. In August, the FDA proposed adding a four-letter suffix to the nonproprietary names shared with brand-name biologics. “Biosimilars are relatively new products in FDA's landscape, so there is still a lot of work to do,” she said.
The newest draft guidance notes that the agency is considering data and information that would support the interchangeability of biosimilars, or the ability of pharmacists to substitute the drugs for brand-name medications without fear of any adverse effects. But the FDA offered no timeline as to when that guidance was coming. Experts have said a determination on interchangeability would offer assurance to insurers and providers, as well as make it easier for a number of yet-to-be-approved biosimilars to hit the market.
A new analysis by IMS Health released Tuesday showed biosimilars could save the U.S. and Europe's five top markets as much as $110 billion by 2020.
The products were supposed to spark competition and lower prices of some of the most expensive drugs being sold in the U.S.
But regulatory hurdles like waiting for guidance from the FDA has prevented many products from gaining approval in the year since the first biosimilar was approved.
On Thursday, Mizuho Securities analyst Eric Criscuolo said in a research note that the FDA's guidance was positive for industry stakeholders, including Pfenex, Coherus BioSciences, and EPIRUS Biopharma.
The draft guidance issued Thursday is open for comments for 60 days.
