Source/Disclosures
Published by:
Bohringer press release
Disclosures:
McCabe reports that he is an employee of Boehringer Ingelheim. Tesser reports financial information with AbbVie, Amgen and Boehinger Ingelheim.
Key points:
- Cyltezo is the only interchangeable adalimumab biosimilar to be launched in the US market.
- Several more adalimumab biosimilars will be launched in July, potentially reducing the price of the drugs.
Cyltezo, Humira’s first interchangeable biosimilar, officially entered the U.S. market on July 1, opening a pipeline that will see half a dozen biosimilars released this month for what has been the top-selling drug in the country.
Six Humira biosimilars will be launched in the United States in July, bringing the total number of adalimumab biosimilars available to eight.
Among the first of these July releases is Cyltezo (adalimumab-adbm, Boehringer Ingelheim), which received FDA approval as an interchangeable biosimilar drug with adalimumab (AbbVie, Humira) and has been approved for inclusion by several pharmaceutical benefit managers, including Optum Rx.
“In general, the market is changing very rapidly and compared to what happened with infliximab and Remicade, that was a drip situation, so it didn’t really impact it until the third and fourth biosimilar.” John Tesser, MD, FACR, of the University of Arizona Health Sciences Center, he told Healio. “This time, it’s happening all at once.”
Yusimry (adalimumab-aqvh, Coherus), Hulio (adalimumab-fkjp, Mylan), Idacio (adalimumab-aacf, Fresenius Kabi), Yuflyma (adalimumab-aaty, Celltrion USA), and Abrilada (adalimumab- afzb, Pfizer).
The result of a deluge of adalimumab biosimilars that hit the market immediately, Tesser said, could be downward pressure on the drug’s price.
“With all these shots at once, it’s going to start to bring down the price of adalimumab in general, that’s what happened with infliximab,” Tesser said. “It took a long time, but it will happen more quickly.”
The first interchangeable arrives on the market
When Cyltezo entered the market as the first interchangeable biosimilar for Humira on July 1, it marked a paradigm shift.
Previous adalimumab biosimilars, including Amjevita (adalimumab-atto, Amgen), which became available in January, and Hadlima (adalimumab-bwwd, Organon), which entered the US market in June, did not have the interchangeable label. Physicians and patients must be involved in the decision-making process to receive Amjevita or other biosimilars without interchangeability designation. Drugs designated as interchangeable, meanwhile, can be swapped at the pharmacy for the reference product, or other biosimilar, without consulting the prescriber, at least where permitted by state law.
Dorothy McCabe
“As a biosimilar that has been granted FDA Interchangeability Designation, pharmacists can automatically substitute Cyltezo for the reference product,” Dorothy McCabe, PhD, FCP, the executive director of biosimilars at Boehringer Ingelheim, Healio told in an email. “Individual state laws control how and if providers and patients are notified.”
Depending on the state in which a physician sees patients, different rules apply for notifying the prescriber of a biosimilar substitution.
“The experience of all rheumatologists across the country is going to be slightly different depending on what state they’re in,” Tesser said.
The interchangeable designation will not allow Cyltezo to be replaced by any adalimumab biosimilar.
Definition of “interchangeable”
Even though Cyltezo will be the first Humira biosimilar to hit the market with an interchangeable designation, that doesn’t mean there will be free patient exchange with Cyltezo.
“I think it’s also very important to remember what interchangeability means,” Tesser said. “It means that it has been designated as having no material differences in efficacy or safety when switching from the originator to the biosimilar and vice versa.”
However, the designation does not permit the exchange of two biosimilars with interchangeable tags at the pharmacy level.
“I don’t think we’ll ever see that happen,” Tesser said.
The road to interchangeability status requires more study and tighter scrutiny than other types of approvals, McCabe said.
“An interchangeable biosimilar must first meet the high FDA standards of a biosimilar,” McCabe said. “So, to obtain the interchangeable designation, the FDA requires additional data, which may include a study of multiple substitutions in patients, known as a switching study. The switch study should demonstrate that patients can be switched without an increase in safety risk or decrease in efficacy, compared to remaining on the reference product.
By all accounts, the introduction of more options has led many experts to believe that access to healthcare will be improved. However, the effects and timing remain uncertain.
Opportunity to increase access to health care
The introduction of so many similar drugs may make it seem inevitable that there will be price cuts for adalimumab across the board, but it’s not a silver bullet, according to Tesser.
“It’s going to come down to contracts and discounts and behind-the-scenes money movement that we never see,” Tesser said. “It should open up the possibility for more people to get the drug, but again, the cost of biosimilars is really huge.”
Overall, as biosimilars become more common, the lives of patients and the economic viability of healthcare systems will improve, McCabe said.
“Cyltezo is the first and only adalimumab biosimilar designated as interchangeable by the FDA, and we will continue to work with insurers, payers and pharmaceutical benefit managers to ensure access to as many people as possible who need it,” McCabe said. “We are confident in the value Cyltezo brings to healthcare and patient communities, supported by a strong efficacy-safety profile established in clinical trials.”
Biosimilars in the United States: Current Status and Future Implications
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