Novartis and Genentech sued SHARx and a Canadian pharmacy for illegally importing their allergy medication Xolair
The pharmaceutical companies claim the imported medication poses safety risks due to potential contamination during shipping
This lawsuit follows a CNBC investigation revealing the growing trend of alternative funding programs
Federal authorities have stated that importing medications from foreign markets is illegal and potentially dangerous
The lawsuit is part of a broader industry-wide effort to stop what pharmaceutical companies consider illegal importation schemes
📖 Full Retelling
Swiss pharmaceutical giant Novartis and biotech firm Genentech filed a lawsuit on February 2, 2025, in U.S. District Court in Michigan against SHARx and a Canadian pharmacy, alleging they are illegally importing the companies' allergy medication Xolair from Canada into the U.S. in violation of FDA regulations. The pharmaceutical companies claim this constitutes a "dangerous scheme" that circumvents FDA regulations prohibiting importation of unapproved medications from overseas. The lawsuit centers on Xolair, an injectable prescription medication used to treat severe asthma, food allergies, and respiratory conditions, with shipments reportedly coming from Campbell Heights Pharmacy in British Columbia, Canada to an allergy and asthma center in Michigan. According to the complaint, biological medicines like Xolair require special care due to their complex composition and sensitivity to storage and handling conditions, making them susceptible to contamination and degradation that could compromise safety and efficacy. This legal action follows a CNBC investigation that revealed the growing prevalence of "alternative funding programs" (AFPs) like SHARx, which promise to connect patients with more affordable medication options but operate in a legally questionable gray area, as federal authorities have consistently stated that importing medications from foreign markets is illegal and potentially dangerous to patients' health.
🏷️ Themes
Pharmaceutical Regulation, Drug Importation, Patient Safety, Healthcare Costs
Novartis AG is a Swiss multinational pharmaceutical corporation based in Basel, Switzerland. Novartis is one of the largest pharmaceutical companies in the world and was the eighth largest by revenue in 2024.
Novartis manufactures the drugs clozapine (Clozaril), diclofenac (Voltaren; sold to GlaxoSm...
Genentech, Inc. is an American biotechnology corporation headquartered in South San Francisco, California. It operates as an independent subsidiary of holding company Roche.
Omalizumab, sold under the brand name Xolair among others, is an injectable medication to treat severe persistent allergic forms of asthma, nasal polyps, urticaria (hives), and immunoglobulin E-mediated food allergy.
Omalizumab is a recombinant DNA-derived humanized IgG1 monoclonal antibody which sp...
In this article NOV.N-CH Follow your favorite stocks CREATE FREE ACCOUNT A sign of Swiss pharmaceutical giant Novartis is seen on the top of a building at Novartis Campus in Basel on Sept. 9, 2025. Fabrice Coffrini | AFP | Getty Images Novartis, one of the world's largest pharmaceutical companies, and Genentech, a major biotech firm, say they've uncovered a "dangerous scheme" to import their allergy medication from Canada into the U.S. in violation of U.S. Food and Drug Administration regulations. Both are suing SHARx — a so-called alternative funding program — and a Canadian pharmacy over the importation of Xolair, an injectable prescription medication for patients with severe asthma, food allergies and respiratory conditions, to an allergy and asthma center in Michigan. "Biological medicines, like the U.S. Xolair medicine, require particular care because their complex composition and sensitivity to variation in storage and handling conditions are susceptible to contamination and degradation that could undermine their safety and efficacy," according to the lawsuit, filed on Feb. 2 in U.S. District Court in Michigan. The suit said the scheme circumvents FDA regulations that generally prohibit importation of unapproved medications from overseas. The plaintiffs are asking 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 funding programs, or AFPs, which promise to connect patients with more affordable options for accessing medications that often come at very high costs. The AFPs are able to obtain the overseas drugs at a substantially reduced price. Federal authorities told CNBC last year that importing medications from foreign markets is illegal and could pose risks to patients' health. watch now VIDEO 31:20 31:20 How high drug costs fueled what feds call an illegal import scheme CNBC Investigations AFPs contract with employer-sponsored health plans to o...
