Teva Pharmaceutical Industries has announced the launch of a generic version of imatinib mesylate, which is currently manufactured by Novartis and is sold under the brand name Gleevec.
Their generic product will be sold in 100-mg and 400-mg versions and will be available for all of the indications for which the drug has been approved by the US Food and Drug Administration (FDA).
On the same day as Teva's announcement, another drug company, Apotex Corporation, also launched a generic version of imatinib. Apotex already sells a generic formulation in Canada and will now be entering the US marketplace.
The advent of marketplace competition, especially when generic versions compete with branded names, almost always signals a decrease in price.
But the question remains: how will these new generics be priced?
The cost of cancer care in the United States and, in particular, the escalating price of new therapeutics have garnered a great deal of media attention and protests from specialists, advocacy groups, and professional organizations.
In a sense, the tyrosine kinase inhibitor imatinib, considered to be one of the most successful targeted agents ever developed, has been the poster child of skyrocketing drug prices.
As previously reported by Medscape Medical News, the drug has come under intense scrutiny because of its dramatic increase in cost and patent disputes.
Developed to treat chronic myelogenous leukemia, imatinib cost about $30,000 per year when it entered the marketplace in 2001.
Since then, the price tag has continuously edged up and has more than quadrupled in the 15 years since its initial launch. In just the 2-year period from 2012 to 2014, the cost of the drug rose from $92,000 to $132,000.
Imatinib has become the bestselling drug for Novartis, generating $4.7 billion worldwide in 2015 and $2.5 billion in the United States.
Exclusivity Keeps Prices High
The new products offered by Teva and Apotex are not the first imatinib generics to enter the marketplace, but, potentially, they represent the beginning of real competition for a piece of the pie.
Last year, Novartis settled a case concerning a version of imatinib developed by a subsidiary of the generics manufacturer Sun Pharmaceuticals Industries. According to the settlement, Sun Pharma's generic version of imatinib would be permitted to enter the US market in February 2016 and, because it had first-filer status, would be entitled to 6 months of marketing exclusivity.
Essentially, that meant that although they would be vying for market shares with Novartis, no other generic versions of imatinib could be launched in the United States until at least August 2016.
"The patent was supposed to expire in January 2015, but due to some sort of agreement between Sun and Novartis — and we don't know what that was ― it was delayed until July 2015," said Hagop Kantarjian, MD, PhD, chair of the Department of Leukemia at the University of Texas MD Anderson Cancer Center in Houston, in an interview with Medscape Medical News.
"So that gave Novartis another 6 months of exclusivity," said Dr Kantarjian, who has for several years campaigned against the high prices of newer cancer drugs.
The FDA approved the generic drug in December 2015, and Sun Pharma launched its generic version on schedule in February 2016.
But now that the 180 days of exclusivity have expired, both Teva and Apotex are ready to sell their own products.
From February until August, the competition was between Novartis, with branded Gleevec, and Sun Pharma, with its generic version. Sun Pharma had initially suggested that its price for generic imatinib would be 30% to 50% lower than the price for Gleevec, but that hasn't been the case, according to Dr Kantarjian.
Dr Kantarjian noted that this first-generic imatinib cost almost the same as branded Gleevec.
"The current Red Book price of Gleevec is $146,000, and the Red Book price for Sun's generic is $140,000, so there really isn't much difference in price," he said. "So this is how pharma does things ― Sun said the price would be 50% to 70% of Gleevec, but it turned out to be 90%."
Dr Kantarjian pointed out that there are already many generic versions of this drug available ― more than 18 worldwide, including three in Canada.
Generic imatinib costs $8000 per year in Canada and about $400 per year in India. "Unfortunately, the drug companies have the Americans 'squeezed' because they can and they are charging what they can," he emphasized.
Novartis Still Holding Major Share
According to Fierce Pharma, Sun Pharmaceuticals reported that their imatinib version had "performed well," but they did not disclose exact figures. The company also pointed out that Novartis continues to retain more than 50% of the market share.
But that 50%-plus figure is expected to collapse once Sun's 180-day exclusivity ends, and it will continue to fall as more competitors enter the marketplace, according to industry reports.
Usually when there are four or more generics on the market, prices tend to drop to less than 50% or more of the branded price, Dr Kantarjian explained. "There are two more drugs now entering the market, and they should help bring down the price."
However, he noted that the companies could have some sort of unwritten agreement to keep the price at more than 50%. "We won't know until we have enough generics," Dr Kantarjian said, "maybe five, six, or seven, and then they will really start competing."
Physicians will be prescribing these generics, as it will allow many more patients to access the therapy, he said. "Their out-of-pocket expenses will be much less, and it will be less expensive for our healthcare system — and insurance companies will certainly prefer the generics as well."
This is already being seen among payers. For example, CVS Health Corp, whose Caremark unit administers drug-benefit plans for employers and insurers, recently announced that it will be dropping Gleevec in favor of generics.
The company intends to switch all patients who are currently taking Gleevec to the generic version.
Mum on Pricing
Thus far, no pricing has been announced, and both Teva and Apotex have declined to share pricing information with Medscape Medical News.
"Teva is committed to the development and production of high-quality, affordable generic medicines for doctors, pharmacists, and, most importantly, patients," said Elizabeth DeLuca, a spokesperson for Teva. "Like all commodity markets, the generic drug market is dynamic, and prices fluctuate based on external factors."
Steve Giuli, director of government affairs and industry relations at Apotex Corp, explained that they have no "other comment beyond the press release" that announced their launch.
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