The Mayo Clinic, Mount Sinai, and around 150 other hospitals have joined other care centers in suing major drug manufacturers over inflated prices for generic medications. The lawsuit alleges that drugmakers like Pfizer, Sandoz, and Teva have illegally collaborated for over a decade to keep generic drug prices high.
The US Supreme Court has rejected Teva’s bid to take up its case with GSK over skinny labels, which approve a generic for some, but not all, of the indications of the reference drug. Teva was sued by GSK in 2014 after it added an indication for congestive heart failure for its generic version of GSK’s heart drug Coreg.
Takeda is preparing for a substantial drop in revenue as two of its major drugs approach patent cliffs this summer. The first is the company’s attention deficit hyperactivity disorder (ADHD) drug Vyvanse, which will lose US exclusivity this August. Takeda’s hypertension medication Azilva will lose exclusivity in Japan this June. The combined hit of the two losses is expected to reach $2.4 billion (330 billion yen).
Around 40% of drugs covered by the UK’s voluntary drug revenue rebate system, the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), are generics and biosimilars. Because of this, the British Generics Manufacturers Association (BGMA) wants in on deliberations just like the organization representing branded medications, the Association of the British Pharmaceutical Industry (ABPI).
The Association for Accessible Medicines, a trade organization for drugmakers producing generics, is undergoing an internal riff that may jeopardize its lobbying power. This follows substantial financial losses and a series of high-profile layoffs. Group insiders lay part of the blame on the board of directors who they argue repeatedly fumbled key organizational decisions.
Takeda is once again in hot water over allegations it participated in a pay-for-delay deal, this time over its gout drug Colcrys. The plaintiffs, a group of drug distributors, claim that Takeda patent settlements with several generics manufacturers delayed the release of cheaper alternative, preventing price drops for the millenia-old drug.
US Senators Bernie Sanders (I-VT) and Bill Cassidy (R-LA) are looking to April 19th when they can start deliberating on changes to an upcoming piece of legislation about generic drugs and the pharmacy benefit manager (PBM) industry. The bipartisan effort comes after increasing public and congressional pressure on PBMs and drug prices.
A case between Supernus and Sage Chemical over the Parkinson’s disease drug Apokyn has far-reaching implications for patients, according to the US Federal Trade Commission. Sage’s generic version of the drug was approved in 2022, but patients could not access it because approval does not cover the injector pen, which is still patented by Supernus.
As the year marches on, Fierce Pharma takes a look at 10 major drugs facing exclusivity losses in 2023. One of the most notable is Humira, AbbVie’s historically expensive blockbuster, which will face stiff competition from several upcoming biosimilars. Other drugs on the list include J&J’s Stellara, Sanofi’s Aubagio, and Takeda’s Vyvanse.
Pfizer was granted a win by the US Court of Appeals for the Federal Circuit in its legal battle with Astellas and Gilead. The case centered around the active ingredient in Hospira, which is also the active ingredient in Astellas and Gilead’s myocardial perfusion imaging drug Lexiscan. The court decided that Hospira didn’t pose any direct infringement on Gilead and Astellas’ patents.
World events and pricing legislation are putting pressure on generic manufacturers, according to an open letter written by the lobbying group Medicines for Europe. The industry group notes that raw material costs have skyrocketed by between 50%-160%, dwarfing the inflation rate of 9%. Energy costs have been another concern due to disruptions caused by the war in Ukraine. Finally, the group points out that drug pricing regulations and other laws have made it difficult for the industry.
Novartis will separate Sandoz, its generics division, into a standalone company. According to Novartis, the move will improve both company’s value to shareholders by letting them participate in decision-making for both companies individually. While Sandoz focuses on generics, Novartis will continue to lean into its central therapeutic foci.
Paul Hudson, CEO of Sanofi, told investors on Thursday, July 28th, that the company’s stock was the “least exposed” to competition from generics for the next decade. According to Hudson, the company’s only upcoming loss of exclusivity through 2030 is Aubagio. The company’s biggest seller, Dupixent, is still growing in sales and a generic is nowhere in sight in the 2020’s.
Strengthening European health systems by promoting the use of off-patent medicines was the topic of several speakers during a presentation the recent Medicines for Europe Conference, held in Sitges, Barcelona, Spain from June 29th to July 1st. The speakers noted that 70% of the drugs dispensed throughout the region are off-patent, and that policies favoring these and biosimilars should be prioritized.
According to Teva Pharmaceuticals, the company’s legal battle with GSK over “skinny labels” portends a greater threat to the generic drug market. Skinny labeling is a practice where a manufacturer can get its generic approved by applying for some of the original drug’s indications, but not all. GSK and others argue that the practice is infringement because the generics are often prescribed off-label for the original drug’s indications. Teva has asked the US Supreme Court to reverse the decision, which ordered the company to pay GSK $235 million.