Potential Generics Could Lower Prices for Oncology, Cardiovascular Drugs | AMCP 2024

There is a potential for up to 50 generic approvals in 2024, although many are not expected to launch this year, according to speakers at a session on traditional pharmaceuticals at the annual meeting of the Academy of Managed Care Pharmacy in New Orleans. Traditional pharmaceuticals, as opposed to specialty ones, tend to be small-molecule drugs that don't require any special administration or oversight.

Generic versions of several high-priced brand-name cancer drugs are expected to come on the market, including two of the major drugs used to treat chronic myelogenous leukemia (CML). Just over 9,000 new cases of CML will be diagnosed this year, according to the American Cancer Society. One of those drugs is Sprycel (dasatinib), a second-generation oral tyrosine kinase inhibitor (TKI) that is priced to cost approximately $220,000 a year.

There are nine potential generics to Sprycel in development, and they could lead to significant cost savings, said one of the presenters, Leslie Fish, RPh, Pharm.D., senior vice president of pharmacy at IPD Analytics LLC.

Apotex, a Canadian company, could be the first company to get a generic to Sprycel on the market launch. After the 180-day first-to-market generic exclusivity, several other companies are poised to start marking .

Tasigna (nilotinib) is also a second-generation TKI used to treat patients with CML, specifically those whose cancers are Philadelphia chromosome positive (Ph+). It has an annual cost of $262,000. One expected generic to Tasgina is likely be priced at 85% of the brand-name drug.

Jeff Casberg

Jeffrey Casberg, M.S., R.Ph., senior vice president of Pharmacy, IPD Analytics LLC, and a member of the Managed Healthcare Executive editorial advisory board, said if other generics of Tasigna become available, prices could drop to 65% of the brand-name drug

A third oncology drug facing generic competition is Halaven (eribulin), an injectable mitotic inhibitor used to treat patients with breast cancer; liposarcoma, a rare form of cancer that develops in fatty issue; and leimyosarcoma, a form of cancer that develops in smooth muscle cells that is also relatively uncommon. The manufacturer, Eisai has a settlement agreement with generic companies. Casberg expected these products could come to market this year or next, but the exact dates have not been released.

It is a different story when it comes to drugs for cardiovascular disease. Patents and litigation mean generics might not become available until next year, or even as late as 2026 or 2027, Casberg told the AMCP audience. Novartis, for example, has many patents protecting Entresto

(sacubitril/valsartan) from generic competition. Entresto is a combination of a angiotensin II receptor blocker and a neprilysin for heart failure. It is priced to cost just over $8.300 a year and generates about $6 billion a year in sales for Novartis.

Another heart failure drug that is a candidate for generic competition is Amgen's Corlanor (ivabradine), an oral potassium channel blocker with priced to cost $7,153 per year “People are waiting for the generic on this one and it’s expensive, but we’re going to have to wait,” Fish said during the presentation. “There are seven filers. If there are settlement agreements already with some companies, we will see a decrease in the price.”

Possible GLP-1 Generic

Victoza (liraglutide) could the first GLP-1 to lose patent exclusivity. It is a once-daily therapy to treat patients with type 2 diabetes and has a price of $10,000 a year. Casberg said Novo Nordisk has reached settlement agreements with many of companies who have possible generics.

“Victoza was a blockbuster drug when it came out,” he said. “Now that this is going multisource, this could solve some of the supply problems [with the GLP-1 shortages].”

Novo Nordisk also markets liraglutide as Saxenda for weight loss, as well as semaglutide products, including Ozempic for diabetes and Wegovy for weight loss. The soaring high demand for GLP-1 products, along with capacity issues at some manufacturing sites, has led to shortages. In November 2023, Novo Nordisk announced it would temporarily reduce the supply of Victoza. The company said shortages are expected until at least the second quarter of 2024.

Although the GLP-1s have been in the limelight, there are other weight loss drug. One of them, Qsymia (phentermine/topiramate), is losing patent protection this year. Two companies that have filed for generic approvals. Teva is likely the first to be approved and will have a 180-day period exclusivity.