Novartis, Genentech sue alleging illegal importation of prescription drug
A sign for Swiss pharmaceutical giant Novartis is seen on top of a building in Basel, Switzerland, on September 9, 2025.
Fabrice Coffrini | AFP | Getty Images
Novartis, Genentech, one of the world’s largest pharmaceutical companies and a major biotechnology firm, says they have uncovered a “dangerous scheme” to import allergy medications from Canada to the United States in violation of US Food and Drug Administration regulations.
He is suing SHARx, a so-called alternative financing program, and a Canadian pharmacy over the importation of Xolair, an injectable prescription drug for patients with severe asthma, food allergies and respiratory conditions, into an allergy and asthma center in Michigan.
“Biologic drugs, such as the U.S. drug
The lawsuit said the plan violated FDA regulations that generally prohibit the import of unapproved drugs from abroad. The plaintiffs are asking the court to stop the import of the drug.
The lawsuit comes on the heels of a CNBC investigation that uncovered a growing class of businesses called alternative financing programs, or AFPs, that promise to connect patients with more affordable options for accessing medications that often come at very high costs. AFPs are able to obtain drugs from abroad at significantly discounted prices.
Federal officials told CNBC last year that importing drugs from foreign markets is illegal and could pose a risk to patients’ health.
AFPs contract with employer-sponsored health plans to offer specialty drug coverage. They often work with private employers, school districts, local governments and unions.
CNBC’s investigation found that in at least one case, an employer asked staff to get their high-cost medications through SHARx or told them it wouldn’t be covered. SHARx defended its business model last year, telling CNBC it offered an alternative to expensive drugs in the US
Central St. SHARx, based in St. Louis, Missouri, did not respond to CNBC’s request for comment on the case.
The shipment of Xolair to the Michigan allergy center came from Campbell Heights Pharmacy in British Columbia, Canada, according to the complaint. The pharmacy also did not respond to a request for comment.
SHARx “continues to brazenly deceive patients into believing they are receiving the same safe, securely provided medications that they would receive from a retail pharmacy in the United States,” the lawsuit said.
The drug had strict shipping and temperature controls, the lawsuit said.
The lawsuit said medications shipped from abroad that are not approved for the U.S. market could lead to contamination, potentially leading to “serious injury or even death to the patient.”
A separate lawsuit filed in late 2024 Gilead SciencesIt similarly alleges that other alternative financing programs are importing drugs illegally. AFPs in the pending case have denied any wrongdoing.
