Apobiologix Launches Pegfilgrastim Biosimilar in Canada

Apobiologix, a division of Apotex, launched its pegfilgrastim biosimilar, Lapelga, in Canada this week. The company’s product, which gained Health Canada’s authorization in 2018, was the first biosimilar pegfilgrastim to be approved in any highly regulated territory.

"With the availability of both Lapelga and [Apobiologix’s filgrastim biosimilar] Grastofil in Canada, patients have even better access to affordable, innovative and effective biological drugs, while delivering significant cost savings to the healthcare system," said Klaus Martin, PhD, president of Apobiologix, in a statement announcing the drug’s launch. According to the company, the pegfilgrastim and filgrastim biosimlars together offer Canada a savings of more than CAD $42 million (US $32 million) annually.

A summary dossier for the drug produced by The Canadian Agency for Drugs and Technologies in Health (CADTH), the Canadian entity responsible for health technology assessments, indicates that Apobiologix has asked for its biosimilar to be listed as the preferred pegfilgrastim product for reimbursement.

The CADTH dossier also includes pricing information; Apobiologix submitted its biosimilar at a 25% discount relative of the reference pegfilgrastim, Neulasta. Despite the substantial discount, CADTH notes that some patients who are candidates for granulocyte colony-stimulating factor drugs can be treated with either pegfilgrastim or filgrastim, so the cheaper, short-acting filgrastim must also be considered a price comparator for Lapelga.

If health plans are convinced that the biosimilar savings are adequate, the biosimilar could increase patient access to pegfilgrastim in Canada; currently, the reference Neulasta is not reimbursed by the majority of drug plans. In fact, says CADTH, only 2 provinces—Alberta and Manitoba—reimburse for Neulasta, and only on a case-by-case basis. However, 8 provinces reimburse for at least 1 dosing regimen of biosimilar filgrastim.

At least 1 health plan has signaled that it intends to capture biosimilars savings with the launch of the new option; in a fall 2018 communication, Green Shield Canada indicated that, in keeping with its biosimilars policy (under which it prefers biosimilars to their reference products in all cases), Lapelga, which is on a high-tier specialty classification, will be covered under a full benefit, while the brand-name Neulasta will only be covered in exceptional circumstances.