A sign for Swiss pharmaceutical giant Novartis is seen atop a building in Basel, Switzerland, on September 9, 2025.
Fabrice Coffrini | AFP | fake images
Novartis, one of the world's largest pharmaceutical companies, and Genentech, a major biotechnology firm, say they have uncovered a “dangerous scheme” to import their allergy medications from Canada into the U.S. in violation of U.S. Food and Drug Administration regulations.
The two are suing SHARx, the so-called alternative financing program, and a Canadian pharmacy over the importation of Xolair, an injectable medication prescribed for patients with severe asthma, food allergies and respiratory conditions, to an allergy and asthma center in Michigan.
“Biological drugs, such as the U.S. drug
The lawsuit says the plan circumvents FDA regulations that generally prohibit the importation of unapproved drugs from abroad. The plaintiffs ask the court to stop the importation of the drug.
The lawsuit comes on the heels of a CNBC investigation that revealed a growing class of businesses called alternative financing programs, or AFPs, that promise to connect patients with more affordable options to access medications that often have very high costs. AFPs can obtain medicines abroad at a substantially reduced price.
Federal authorities told CNBC last year that importing drugs from foreign markets is illegal and could pose health risks to patients.
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 revealed that in at least one case, an employer required its staff to get their high-cost medications through SHARx or said they would not be covered. SHARx last year defended its business model, telling CNBC that it offers an alternative to expensive drugs in the US.
SHARx, based in St. Louis, Missouri, did not respond to CNBC's request for comment on the lawsuit.
According to the complaint, the shipment of Xolair to the Michigan allergy center came from Campbell Heights Pharmacy in British Columbia, Canada. The pharmacy also did not respond to a request for comment.
The lawsuit says SHARx “continues to blatantly deceive patients into believing that they are receiving the same safe and securely supplied medications that they would receive at a U.S. retail pharmacy.”
The drug has strict shipping and temperature controls, according to the lawsuit.
Medications not approved for the U.S. market that are shipped from abroad can cause contamination, which could lead to “serious patient injury and even death,” according to the lawsuit.
A separate lawsuit, filed in late 2024 by Gilead Sciencessimilarly alleges that other alternative financing programs import drugs illegally. The AFP involved in the case, which is pending, denied any wrongdoing.
