Cyltezo launches as first interchangeable Humira biosimilar
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Key takeaways:
- Cyltezo is the only interchangeable adalimumab biosimilar to launch on the U.S. market.
- Several more adalimumab biosimilars are set to launch in July, potentially driving down the price of the drugs.
Cyltezo, the first interchangeable Humira biosimilar, officially entered the U.S. market on July 1, opening a floodgate that will see the release this month of half a dozen biosimilars for what has been the top selling drug in the country.
Six Humira biosimilars are set to launch in the United States in July, bringing the total number of available adalimumab biosimilar drugs to eight.
Among the first of these July releases is Cyltezo (adalimumab-adbm, Boehringer Ingelheim), which has received FDA approval as an interchangeable biosimilar drug to adalimumab (AbbVie, Humira) and has been approved for inclusion from several pharmacy benefit managers, including Optum Rx.
“In general, the market is changing very rapidly, and compared with what happened to infliximab and Remicade — that was a drip-drip-drip situation, whereby it really had not much impact until the third and fourth biosimilars hit,” John Tesser, MD, FACR, of the University of Arizona Health Sciences Center, told Healio. “This time, it is happening all at once.”
Also expected to make their U.S. debuts in July are 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 hitting market at once, Tesser said, may be downward pressure on the drugs price.
“With all of these hitting at once, it will start driving the price down of adalimumab in general, that is what happened with infliximab,” Tesser said. “That took a long time, but this will happen more quickly.”
The first interchangeable hits 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 U.S. market in June, did not carry the interchangeable label. Physicians and patients are required to be involved in the decision-making process to receive Amjevita or other biosimilars with no interchangeability designation. Drugs designated as interchangeable, meanwhile, can be swapped at the pharmacy in place of the reference product, or other biosimilar, without consulting the prescribing physician — at least where allowed by state law.
“As a biosimilar that has been granted the FDA’s interchangeability designation, pharmacists can auto-substitute Cyltezo in place of the reference product,” Dorothy McCabe, PhD, FCP, the executive director of biosimilars at Boehringer Ingelheim, told Healio in an email. “Individual state laws control how and whether providers and patients must be notified.”
Depending on the state where a physician sees patients, different rules apply for notifying the prescribing doctor about a biosimilar substitution.
“The experience of all rheumatologists around the country will be somewhat different depending on the state they are in,” Tesser said.
The interchangeable designation will not allow just any adalimumab biosimilar to be substituted for Cyltezo.
Defining ‘interchangeable’
Although Cyltezo will be the first Humira biosimilar to hit the market with an interchangeable designation, that does not mean there will be a free-for-all for swapping patients to Cyltezo.
“I think it is also really important to remember what interchangeability means,” Tesser said. “It means it has been designated as having no material difference on efficacy or safety when one switches from the originator to the biosimilar and back again.”
However, the designation does not allow any two interchangeable-tagged biosimilars to be switched at the pharmacy level.
“I don’t think we will ever see that happen,” Tesser said.
The road to interchangeability status involves more studies and stricter scrutiny than other types of approvals, McCabe said.
“An interchangeable biosimilar first must meet the high FDA standards of a biosimilar,” McCabe said. “Then, to achieve the interchangeable designation, the FDA requires additional data, which may include a study of multiple substitutions in patients, known as a switching study. The switching study must show that patients can be switched with no increased risk in terms of safety or diminished efficacy, as compared to remaining on the reference product.”
By all accounts, the introduction of more options has many experts believing that access to health care will be improved. However, the effects and timeline remain uncertain.
Potential to increase access to health care
The introduction of so many similar drugs may make it seem inevitable that there will be a reduction in adalimumab prices across the board, but it is not a silver bullet, according to Tesser.
“It is going to be dependent on the contracts, rebates and movement of money behind the scenes that we never see,” Tesser said. “It should open the ability of more people to get the drug, but even then the cost of biosimilars is really huge.”
In general, as biosimilars become more commonplace, patients’ lives and economic sustainability of the health care system 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, payors and pharmacy benefit managers to ensure access for as many people who need it as possible,” McCabe said. “We’re confident in the value that Cyltezo brings to the health care and patient communities, backed by a strong efficacy-safety profile established in clinical trials.”
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Boehringer press release
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