Health Canada  has suspended the establishment license of Biolyse Pharma Corporation’s facility in St. Catharines, Ontario because of “significant concerns” with the manufacturing process discovered during a recent inspection, according to a notice published by Health Canada.

Injectable paclitaxel (6 mg/mL), used in the treatment of certain lung and breast cancers, is currently the only drug produced at that facility. The suspension of the establishment license means Biolyse is not permitted to sell paclitaxel from that facility to the Canadian market until the manufacturing concerns are fully addressed and the suspension on its establishment license is lifted. To receive and maintain an establishment licence in Canada, a company must comply with good manufacturing practices.

Health Canada has confirmed that supplies of paclitaxel are available from another manufacturer that is licensed to produce it in Canada. “The Department is also in regular contact with the provinces and territories regarding the supply situation. There has been no supply disruption caused by the licence suspension,” said Health Canada in its notice.

In the short term, Health Canada is allowing the Biolyse product currently on the market to continue to be used for treatment. However, “Health Canada cannot be assured that future supplies of paclitaxel from Biolyse would be safe and effective for use by patients until the serious manufacturing violations are resolved,” said the agency.

Health Canada said it is continuing to work with the staff at Biolyse Pharma to resolve the issues identified during the inspection as quickly as possible.

Source: Health Canada