FDA Approves First Biosimilar for Multiple Sclerosis

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved Tyruko (natalizumab-sztn) as the first biosimilar for adults with relapsing forms of multiple sclerosis (MS), a move that could substantially reduce treatment costs for MS patients. Biosimilars are “highly similar” to brand-name biologic medicines, but about 30% cheaper.

"Approval of the first biosimilar product indicated to treat relapsing forms of multiple sclerosis furthers the FDA's longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost," said Sarah Yim, MD, director of the FDA’s Office of Therapeutic Biologics and Biosimilars.

Like Tysabri (natalizumab), the biologic it is modeled after, Tyruko is administered by infusion every four weeks to patients with MS, a chronic disease that attacks the body’s central nervous system, causing numbness, paralysis, loss of vision, fatigue and pain. Many MS patients experience periods of remission, followed by relapses.  

The listed cash price for a single vial of Tysabri is over $17,000, although the discounted price for insured patients is about $8,500 or $102,000 a year. Sandoz, a pharmaceutical company that specializes in biosimilars and generics, has not revealed its pricing plans for Tyruko or said when it will become available. Sandoz is a division of Novartis.

“Of the nearly one million people in the US living with multiple sclerosis, hundreds of thousands experience disease relapse. Tyruko has the potential to extend the reach of natalizumab treatment for these patients, increase healthcare savings and fuel innovation through competition in the market,” Keren Haruvi, President North America, Sandoz Inc., said in a news release.

Like Tysabri, Tyruko may also be used to treat adults with moderate to severe symptoms from Crohn's disease who have not responded well to other treatments. Crohn’s causes chronic inflammation in the digestive tract.

The FDA says patients using natalizumab products (including Tyruko and Tysabri) are at higher risk of developing progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that can lead to death or severe disability. Because of that risk, prescribers must evaluate patients three and six months after their first infusion, every six months thereafter, and even after they discontinue treatment.

Growing Market for Biosimilars

Patients have long complained about the high price of MS drugs in the US, which cost two to three times more than the same drugs in Canada, Australia or the UK. One reason biologics are so expensive is that they derived from living organisms such as animal cells or bacteria, making them costly to develop.

Drug patents also last a long time – usually five years – before a “copycat” version can be introduced. Patent holders often take their competitors to court to further delay the introduction of generics or biosimilars, as was the case with AbbVie’s Humira, a biologic widely used to treat rheumatoid arthritis and other chronic inflammatory diseases. At least 9 new Humira biosimilars are finally entering the U.S. market this year.

Last week, CVS Health announced that it was launching a wholly owned subsidiary called Cordavis, which will work with drug manufacturers to commercialize biosimilars. The first biosimilar CVS plans to market in early 2024 is Hyrimoz (adalimumab-adaz), a biosimilar for Humira produced by Sandoz. CVS says the list price of the Hyrimoz will be over 80% lower than the current list price of Humira.

"Biosimilars are crucial to creating competition and reducing costs for specialty pharmaceuticals where drug prices are rising the fastest," said Prem Shah, PharmD, Executive Vice President and Chief Pharmacy Officer for CVS. "Through our direct involvement, we will expand the supply chain and ensure biosimilar availability in the market.”

As more patents expire, the biosimilars market in the U.S. is projected to grow from $6.7 billion in 2021 to more than $100 billion in 2029, according to one market forecast..

U.S. Prescription Opioid Use Fell 7.4% in 2022

By Pat Anson, PNN Editor

The amount of prescription opioids sold in the United States fell another 7.4% last year, according to a new report by the IQVIA Institute, a healthcare data tracking firm.

Since their peak in 2011, per capita use of prescription opioids by Americans has declined 64 percent, falling to levels last seen in the year 2000. Despite that historic decline, fatal overdoses in the U.S. have climbed to record levels, fueled primarily by illicit fentanyl and other street drugs.

“The greatest reductions in prescription opioid volume — measured in morphine milligram equivalents (MME) — have been in higher-risk segments receiving greater than 90 MMEs per day,” the IQVIA report found. “Despite significant progress in reducing opioid prescriptions to combat the opioid overdose epidemic, overdose deaths have been rising, primarily due to illicit synthetic opioids.”

The CDC estimates there were 108,712 overdose deaths in the 12-month period ending in November, 2022. About 72,000 of those deaths involved heroin or synthetic opioids such as fentanyl.

By comparison, drug deaths involving legal prescription opioids have remained relatively flat, averaging about 16,000 a year since 2017. They ticked upwards in 2020 and 2021, but appear have trended downward again in 2022, according to the IQVIA.

Prescription Opioid Use and Opioid Overdose Deaths

It appears likely that prescription opioid use will fall again in 2023, due in part to further cuts in opioid production quotas imposed on drug makers by the Drug Enforcement Administration. The DEA says the opioid supply will still be “sufficient to meet all legitimate needs,” but as PNN has reported, some manufacturers are currently reporting shortages of oxycodone and hydrocodone.      

Pain patients have complained for years about chain pharmacies being unable or unwilling to fill their opioid prescriptions, but the problem seems to have grown worse in recent months, particularly at CVS.

“Every month I have to spend hours on the phone trying to find a location that has them in stock,” a CVS customer in Indiana told us. “We should not have to be subjected to this every month!” 

“Some pharmacists are anti opiate. No matter what. She was rude and she is the manager. While it’s hard every month to fill, this time her rude attitude was over the top,” said another CVS customer in Colorado.

Medication Costs Declining 

There is some good news in the IQVIA report: medications are getting cheaper. The average amount paid out-of-pocket for a retail prescription fell from $10.15 in 2017 to $9.38 in 2022. Uninsured patients who pay the full amount in cash have also seen their drug costs decline slightly.

The use of manufacturer copay assistance programs and coupons is growing, collectively saving patients about $19 billion in 2022.

Over the next five years, growth in the use of biosimilar drugs to treat autoimmune conditions, diabetes and cancer is expected to save consumers over $180 billion. Like generic drugs, biosimilars are medications that can replace more expensive biologics such as Humira, which are losing patient protection.

Altogether, spending on medicines for the next five years is expected to be flat, according to the IQVIA, with rising costs in some drug classes offset by declines in others.