After a committee hearing on the price of rheumatoid arthritis drugs last week, Senator Susan Collins (R-ME) announced that she is working on a bill designed to lower drug costs. According to Bloomberg Law, the aim of the legislation would be to restrict “evergreening,” described as “the practice of extending protection for a product by taking out a new patent based on a different indication or new formulation.” Senator Collins states that, according to reports, Humira (adulimumab) is covered by more than 100 patents, “many of which were added as the expiration date of the drug’s main patent approached in 2016.” Humira is used to treat rheumatoid arthritis and several other autoimmune diseases.
Bloomberg Law notes (and we have previously reported) that the annual price of Humira has more than doubled since 2012. There is currently no biosimilar competition for Humira in the U.S. market. Biosimilar versions of Humira made by Amgen and Boehringer Ingelheim were approved by the FDA in 2016 and 2017 respectively, and the FDA recently accepted an aBLA from Sandoz. However, these biosimilars have not yet entered the market.
Senator Collins is also reported to support the CREATES Act, which “would prevent brand drugmakers from using risk evaluation and mitigation strategies (REMS) as an excuse for withholding product samples that generic and biosimilar companies need to perform bioequivalence studies.” Senator Collins noted that her committee will continue to hold hearings on drug prices in the coming months, including a hearing in April on the increasing cost of insulin.
Stay tuned to Big Molecule Watch for further developments.