Generic medicines face no tariffs, though the Trump administration reserves the right to revisit that in the future. Some branded drugmakers face a reduced tariff rate, but that could change if they don’t reach a so-called most-favored nation drug price deal.
Generic drugs don’t need lengthy clinical trials to support a submission seeking FDA approval. The regulator now proposes ending this testing requirement for biosimilars, products that reference complex biologic medicines.
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Dan Reedy, senior director of pricing and underwriting for Abarca, spoke recently with MedCity News about what payers should consider as they explore new models and press for greater transparency.
Generic drugs are the pharmaceutical products mainly affected by the missile attacks disrupting shipping in the Red Sea. While the extra costs borne by drug companies aren’t causing an immediate spike in product prices, experts say they’ll eventually be factored into prices if the attacks become a long-term problem.
The Federal Trade Commission says more than 100 patents from 10 biopharma companies are improperly listed in the FDA’s official publication of approved products. Such listings delay generic competition, which reduces consumer choice and keeps prices high, the regulator said.
Generic drugmakers Teva and Glenmark recently became the sixth and seventh drugmakers to resolve criminal charges as a result of the DOJ’s yearslong investigation into generic drug price fixing. The settlement agreement requires both companies to pay hefty fines as well as divest their drug lines for pravastatin, a widely used statin that lowers cholesterol.
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The restructuring of cardiovascular drugmaker Amarin means the layoff of about 30% of staff. Sales of Vascepa, the company’s only commercialized product, have suffered as generic versions gain traction in the market.
CVS Caremark and GoodRx created a new program called Caremark Cost Saver, which will become available starting January 1, 2024. Through the program, eligible CVS Caremark commercially insured members will have access to GoodRx’s prescription pricing on generic medications.
In acquiring Mayne Pharma’s U.S. portfolio, Dr. Reddy’s gains a birth control pill whose rapid sales growth is attributed to a direct-to-consumer marketing strategy. The deal also includes pipeline products and approved products that are not yet on the market.
Amazon's RxPass offers more than 50 generic drugs for more than 80 common conditions at the flat fee of $5 a month for Prime members. While one expert says its a significant move by Amazon, another said more needs to be done.
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The charges, filed in Philadelphia federal court, allege that Teva conspired with four other generic drug companies to fix prices, rig bids and allocate customers. Teva - which the Justice Department and New York's state government also sued this month for unrelated allegations - said it rejected the allegations.
A federal appeals court upheld two key patents covering Amgen's Enbrel, thus further preventing Novartis' generics unit from launching its biosimilar. However, an analyst wrote that the probability of Sandoz overturning the decision is low.
The suit, filed Wednesday in federal court by more than four dozen attorneys general, accuses 26 generic drug companies and 10 executives of keeping prices artificially high for the drugs. It is the third in a series of antitrust lawsuits targeting the industry.
An analyst wrote that a best-case scenario for Amarin is that it may take 2-3 years for generic versions of Vascepa to hit the market. But the company has likely lost its luster as an acquisition target.
According to a report, drugmakers are expected to lose $17 billion in worldwide sales due to patent expirations this year. Two reports list 18 drugs as losing patent protection or exclusivity, though not all drugs listed here will necessarily face generic or biosimilar competition in 2020.