Managed Care Update: FDA Releases Guidelines on Biosimilar Interchangeability

The FDA recently released its guidance for drugmakers attempting to gain approval for interchangeability between a biosimilar and reference product. 

The guidance recommends that in order for drugmakers to get a biosimilar approved as interchangeable, they must conduct one or more “switching studies,” demonstrating that patients can alternate between both products without decreases in efficacy or increases in adverse events. 

The guidance is important to payers because it lays out a roadmap for drugmakers to expedite the transition from a biosimilar becoming an approved product to becoming interchangeable, ultimately making point-of-sale substitutions possible. According to Norm Smith, president of Viewpoint Consulting Inc, the goal of less-expensive product substitutions is at the core of every payer’s mission.

“Allowing pharmacists to change a brand to a generic (or biosimilar) is the goal of every payer,” he explained. “In all the conversations we’ve had about biosimilars and their ability to penetrate the market, this is the central issue in the eyes of the payers. The more ‘automatic’ that change process is, the more biosimilars will be used. Obviously, getting FDA approval for a pharmacist to make the changeover without having to obtain the treating providers approval is the goal.”

The guidance notes that interchangeability will be determined on an individual basis, depending on what type of product the biosimilar is and what type of condition it treats. 

According to the guidance: “The data and information to support a showing that the proposed interchangeable product can be expected to produce the same clinical result as the reference product in all of the reference product’s licensed conditions of use may vary depending on the nature of the proposed interchangeable product and may include, but need not be limited to, an evaluation of data and information generated to support a demonstration of a biological product’s biosimilarity.” 

Mr Smith clarified that this process is integral because of the scope of biosimilar products looking to come to the market as interchangeable drugs.

“This guidance would permit products to be looked at on a case-by-case basis,” Mr Smith said. “There is no sweeping permission that all biosimilars are interchangeable with all the originators drugs. Each product, and each biosimilar brand of product, will be reviewed individually, not as a product class.” 

The FDA also outlined a number of different types of data that can be presented when applying for interchangeability approval. The guidance notes that the FDA will consider all of these data together when making its decision. 

“Because biologics are much more complex to make, and have some variations in the molecule, the FDA is looking at the clinical efficacy and safety changes that may occur with that somewhat different molecule,” Mr Smith added. 

Mr Smith highlighted part of the FDA guidance that demonstrates the complexity and differences between biosimilar and biologic products, the recommendation that biosimilar products use the same type of delivery method as the biologic. 

“This guidance document states that biosimilar manufacturers should use the same type of delivery device as the originator brand,” he said. “That insures the patient will know how to inject themselves, since many of these products are self-injectables. If a biosimilar manufacturer has conducted studies using a different delivery device, they may not get approval because their device is different!”

Ultimately, Mr Smith noted that the guidance serves as a step in the right direction for the specialty pharmacy and managed care industries; however, he cautioned that interchangeability does not always result in significant cost savings. 

“This guidance gives a pathway for a biosimilar manufacturer to make their product as close to the originator’s as possible,” he said. “This may allow pharmacy, particularly specialty pharmacy, to more easily convince the provider the biosimilar can serve as a replacement for the originator’s brand. This is assuming the biosimilar’s net cost is lower than the net cost of the originator’s product, which may not always be the case. Many of the branded companies will give further discounts to fight the routine adoption of their biosimilar replacement. Amgen is doing that now with Neupogen (filgrastim).”

Public comment for the draft guidance ends on March 20, 2017.