FDA Accepts First US Biosimilar Application

In July, the FDA accepted the first Biologics License Application filed under the biosimilar pathway created by the Biologics Price Competition and Innovation Act of 2009.

The application is for filgrastim, which the application’s sponsor, Sandoz, markets as ZARZIO outside the United States. The company, which is part of Novartis Group, has 3 biosimilars marketed outside the United States.

The product will mimic Amgen’s NEUPOGEN, which is formulated to decrease the incidence of infection in patients with nonmyeloid malignancies who are receiving myelosuppressive anticancer drugs that are associated with a significant incidence of severe neutropenia with fever.

The application follows years of debate over biosimilar medications in the United States, and at a time when growth in the area is expected to outpace growth within traditional pharmaceuticals. According to the IMS Institute for Healthcare Informatics report The Global Use of Medicines: Outlook through 2017, biologic agents are expected to represent 19% to 20% of total medicine sales in 2017. “It’s meaningful to have the first application, and after 4 years since the passage of the law, it now enables us all to move to an examination of the implications,” Michael Kleinrock, research director for the IMS Institute for Healthcare Informatics, told Pharmacy Times.

“It’s hard to see a change for specialty marketing in general from this, but in 2 to 3 years, with more molecules facing biosimilar competition, biologics in general will evolve to a state where some biologics face late life cycle challenges. That would be new, but it’s still a few years off.”

Specialty medications have been a primary driver of medication spending level increases, and are also expected to be the biggest driver of brand name spending in developed markets over the next 5 years, the IMS Institute for Healthcare Informatics report states.

According to Kate Keeping, senior director of Biosimilars Research at Decisions Resources Group, Sandoz’s application confirms manufacturers’ desire to use the FDA’s pathway.

“In the past, there has been speculation that the pathway would never be used due to the need to disclose the dossier to the reference sponsor, and the lack of confidence in what’s required due to the relative lack of guidance from the FDA,” Keeping told Pharmacy Times. “There are an increasing number of guidelines from the FDA now, and we’ve seen a rapid increase in the number of biosimilars under development for the US market, so this event will boost confidence that a US biosimilar market could become a reality.”

In addition, the application could open a new market to manufacturers, while also allowing managed care organizations to slow spending growth, Keeping said. Despite this, Decision Resources’ primary market research shows only a moderate level of planning for biosimilars among managed care organizations.

“This application will likely spur payers to step up their planning,” Keeping said. “Likely strategies in the near term will include development of physician and patient education programs. Once the first biosimilars are available, expect to see much more aggressive strategies from payers to drive uptake, if the biosimilar’s price is right.”

Once approved, the first US biosimilars are expected to offer modest price reductions compared with brand name products, which is due, in part, to the costs associated with development and manufacturing. In addition, the low likelihood of simultaneous biosimilar launches will create less pressure to undercut the reference brand, although price erosion for biosimilars and their reference brands is expected to occur eventually, Keeping stated.

The FDA’s interchangeability designation will likely play a key role in biosimilar adoption, Keeping said. Many states enacting biosimilar legislation require the interchangeability designation in order for a biosimilar substitution.

“However, because the FDA has not provided any guidance on how biosimilar sponsors should demonstrate interchangeability, we do not expect the first wave of US biosimilars to carry this designation,” Keeping stated. “In the absence of pharmacy-level substitution, uptake will be driven by the prescriber and payers. We expect biosimilar erosion of reference brand sales to be a much slower process than generic erosion for these reasons.”