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.
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.
AMCP Posters Tackle Interchangeability and Medicaid, Factors Driving Biosimilar Access
April 24th 2024Two posters from the Academy of Managed Care Pharmacy (AMCP) annual meeting explore how an interchangeable insulin glargine biosimilar plays into Medicaid budgets and the top factors driving access to biosimilars.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.