House to Investigate High Drug Costs for Humira, Enbrel, and Lantus

Yesterday, the House Committee on Oversight and Reform launched a wide-ranging investigation into prescription drug pricing in the United States.

The committee’s chair, Representative Elijah Cummings, D-Maryland, sent letters to 12 drug makers seeking information and documents related to pricing practices. According to the committee’s statement, the letters seek further information about price increases, investments in research and development, and corporate strategies to defend market share. The committee will next hold a series of hearings on drug pricing.

“The Committee on Oversight and Reform is investigating the actions of drug companies in raising prescription drug prices in the United States, as well as the effects of these actions on federal and state budgets and on American families,” Cummings wrote in a statement announcing the investigation. “For years, drug companies have been aggressively increasing prices on existing drugs and setting higher launch prices for new drugs while recording windfall profits. The goals of this investigation are to determine why drug companies are increasing prices so dramatically, how drug companies are using the proceeds, and what steps can be taken to reduce prescription drug prices.”

Among the products that are subject to the investigation are AbbVie’s brand-name adalimumab, Humira; Amgen’s etanercept, Enbrel; and Sanofi’s insulin glargine, Lantus. All 3 of these products are the targets of as-yet unrealized biosimilar and follow-on competition:

• Humira has been the subject of a spate of recent patent litigation settlements, all of which are poised to keep approved biosimilars from reaching the US marketplace before 2023. Meanwhile, biosimilars of adalimumab have already launched in the European Union.
• Enbrel has been the subject of a long-running patent dispute between Sandoz, maker of biosimilar Erelzi (which was FDA approved in 2016 but remains unlaunched), and Amgen, maker of the reference drug. A recent report found that Amgen filed nearly 3 times more patents on the etanercept product in the United States than it did in the European Union or Japan, a fact that complicates the patent litigation process for US biosimilars.
• Lantus faced competition from Merck and Samsung Bioepis’ follow-on insulin glargine, Lusduna Nexvue, after the FDA tentatively approved the product in July 2017. However, in October 2018, Merck announced that it was terminating its agreement with Samsung for the product after facing significant challenges, including long-running patent litigation, in bringing the drug to market. Mylan and Biocon, which have developed an insulin glargine follow-on that is already approved and marketed as Semglee in the European Union, received a Complete Response Letter from the FDA for their product in June 2018.

Additional products that are subject to the committee’s investigation are cancer drugs imatinib (Novartis’ Gleevec) and lenalidomide (Celgene’s Revlimid), pain drug pregabalin (Pfizer’s Lyrica), and glatiramer acetate (Teva’s Copaxone), among others.