Apobiologix's Biosimilar Pegfilgrastim Approved in Canada

On June 1, drug maker Apotex announced that its Apobiologix division has received approval from Health Canada for its pegfilgrastim biosimilar, Lapelga. Lapelga is the first pegfilgrastim biosimilar to be approved in a highly regulated territory.

Klaus Martin, PhD, president of Apobiologix, hailed the approval, saying, “Biosimilars provide an opportunity for the sustainability of global healthcare systems by increasing competition and reducing costs, and very importantly, giving patients increased access to highly effective and often lifesaving biological drugs.”

Approval of the biosimilar was based on data from a phase 2 pharmacokinetic and pharmacodynamic study in healthy volunteers, and from data from the phase 3 APO-Peg-03 trial in patients with breast cancer who were undergoing chemotherapy. The phase 3 study revealed similar safety profiles between the biosimilar and the US-licensed Neulasta. The biosimilar and its reference also had similar immunogenicity, with a low incidence of anti-drug antibodies observed in both the biosimilar and reference arms.

In bringing its pegfilgrastim to the Canadian market, Apobiologix has requested that the biosimilar be listed as the preferred pegfilgrastim product for reimbursement in Canada. The drug maker has submitted its product to The Canadian Agency for Drugs and Technologies in Health, the nation’s independent health technology assessment body, at a 25% discount to the list price of the reference Neulasta, producing a savings of $626.24 (approximately $484 USD) per 6-mg prefilled syringe.

Currently, the reference pegfilgrastim, at its average cost of approximately $12,525 (approximately $9687 USD) for a patient receiving 5 cycles of chemotherapy, is not widely reimbursed. Neulasta is not a benefit provided under drug plans in British Columbia, Saskatchewan, Ontario, Nova Scotia, Prince Edward Island, or Newfoundland and Labrador. Neulasta is available as a restricted benefit—for example, with prior authorization—in Alberta, Yukon, Northwest Territories, the Non-Insured Health Benefits Program, the Department of National Defense, and Veterans Affairs Canada. In Manitoba, reimbursement for pegfilgrastim is assessed on a case-by-case basis.

In the United States, no pegfilgrastim biosimilar has yet been launched, though Mylan and Biocon's Fulphila has been newly approved by the FDA. Other products await regulatory decisions by the FDA; Apotex has submitted a Biologics License Application (BLA) for Lapelga, and Coherus has resubmitted its BLA for CHS-1701 after having received a Complete Response Letter in 2017.