Status: ongoing

Case: 4:26-cv-10371

Novartis AG and Genentech v SHARx and Campbell Heights Pharmacy

In February 2026, Novartis AG and Genentech filed a civil complaint against an alternative funding program, SHARx, and a pharmacy in British Columbia, Canada, which they say supplied Michigan patients with non-FDA-approved, Canadian versions of the asthma biologic Xolair.

The complaint argues that SHARx and the pharmacy are violating the Lanham Act by providing unknowing U.S. patients with medicine that has not been "approved by the FDA for use among the U.S. population nor subjected to Plaintiffs’ carefully designed quality control measures, which ensure that the medicines are properly manufactured, packaged, stored, and shipped." The document goes on to discuss material differences between Canadian and U.S. Xolair for Americans, including:

  • inability to verify whether Canadian Xolair was shipped under the right conditions to maintain its effectiveness,
  • U.S. patients' lack of access to safety recalls for Xolair that was only supposed to be sold in Canada, and
  • differences in instructions and packaging between the two products that may cause confusion and errors.

 

 

Patients may be confused by differences in American and Canadian Xolair packaging inserts, because the medicines are approved for different conditions in each country.

(Photo: Complaint)

Court filings