PharmaEssentia recently announced that its innovative long-acting interferon, Ropeginterferon alfa-2b (Ropeg), has been officially listed on Health Canada’s “List of Drugs for Exceptional Importation and Sale.” Through this special importation mechanism, Ropeg has already been shipped to the Canadian market to address the country’s severe drug shortage.
While PharmaEssentia has not disclosed the specific volume of shipments approved by Health Canada, CEO Ko-Chung Lin previously indicated that the company expects to supply Ropeg for approximately 200 to 300 patients in Canada.
On March 6, PharmaEssentia released a statement on its official website explaining that Ropeg is an innovative long-acting interferon independently developed by the company. It has been approved for the treatment of adults with polycythemia vera (PV) in multiple countries, including the United States, Japan, China, and across Europe. Recently, health authorities in Europe, the U.S., Canada, Brazil, and other nations have issued notices regarding an interruption in the supply of Ropeg’s competing drug Pegasys (Peginterferon alfa-2a). Originally produced and sold by Roche, the rights to Pegasys were transferred in 2021 to Austria-based Pharma&. However, Pharma& has been unable to meet production demands, leading to widespread reports of supply shortages in numerous countries.
PharmaEssentia noted that Canada officially announced a shortage of Pegasys in October 2024. By January 2025, the situation had escalated to a Tier 3 Drug Shortage, the most severe classification, indicating a critical impact on local drug supplies and the healthcare system. To ensure patients receive timely and necessary treatments, Health Canada approved the inclusion of Ropeg—a drug in the same interferon class—on its list for exceptional importation and sale.
PharmaEssentia is working closely with its Canadian licensing partner, FORUS Therapeutics Inc. (FORUS), to rapidly obtain import approvals and expedite delivery under the relevant regulations, aiming to make Ropeg available in Canada as quickly as possible.
The company pointed out that drug prices for new therapies in Canada are generally much lower than in the U.S. However, since Ropeg’s clinical trials for essential thrombocythemia (ET) and polycythemia vera (PV) were conducted in Canada, local physicians and patients have had highly positive experiences with the treatment. The Canadian MPN (myeloproliferative neoplasm) community has long anticipated Ropeg’s availability in the market. Thanks to the team’s efforts, PharmaEssentia signed an exclusive commercialization agreement with FORUS in August 2024, paving the way to overcome pricing challenges in Canada.
According to the agreement, FORUS is responsible for regulatory approval and commercial sales of Ropeg in Canada. The contract includes milestone payments to PharmaEssentia of up to approximately USD 107 million, covering both regulatory approvals and sales milestones. Additionally, PharmaEssentia will receive a substantial double-digit percentage in sales royalties from FORUS as part of the agreement.
PharmaEssentia emphasized that Ropeg’s inclusion on Health Canada’s exceptional import list ahead of its official regulatory approval demonstrates both the strong market demand for the drug and the company’s strategic foresight. This move highlights PharmaEssentia’s ability to respond swiftly to market dynamics and ensure a stable drug supply. It also lays a solid foundation for Ropeg’s future commercial launch in Canada, enabling PharmaEssentia not only to secure additional royalty revenues through special importation but also to strengthen its presence in the North American market and bring the benefits of Ropeg to more patients.
Resource: 競品缺貨發酵！藥華藥血癌藥 Ropeg 獲准專案出口加拿大
