A severe global shortage of blood cancer medications has prompted Taiwan-based PharmaEssentia to step in with emergency supplies. Pegasys, a blood cancer treatment drug sold by Pharmaand under license from Roche, is facing a supply crisis expected to last up to two years. In response, regulatory authorities in North America and Europe have issued emergency procurement orders for Ropeg, PharmaEssentia’s new blood cancer drug. The first batch of life-saving Ropeg is set to be shipped this month.

PharmaEssentia is also in discussions with U.S. commercial insurance companies and hospitals to expand Ropeg procurement and help fill the supply gap left by Pegasys.

Industry analysts believe this event will significantly boost PharmaEssentia’s standing, potentially securing its place among major global pharmaceutical companies. The company’s annual revenue is projected to increase by over NT$10 billion, with total revenue expected to surpass NT$20 billion this year.

Experts highlight two major implications of this development. First, with the combination of its existing business growth and emergency orders replacing Pegasys, PharmaEssentia’s international presence will see a significant boost. Second, if Ropeg successfully replaces Pegasys, PharmaEssentia will capture a major share of the market, accelerating its rise to a leadership position in this field.

PharmaEssentia stated that since October last year, reports of delayed Pegasys shipments have surfaced, with the shortage worsening over time. The UK’s National Health Service (NHS) has already issued directives to subsidize Ropeg as a replacement for Pegasys during the shortage. Meanwhile, Canadian health authorities have secured an initial batch of Ropeg via a special import program, with shipments expected to begin in February.

Currently, in the global polycythemia vera (PV) pharmaceutical market, Ropeg competes with three other drugs, including Pegasys, a type of interferon medication marketed by Pharmaand in Austria.

PharmaEssentia CEO Ko-Chung Lin noted that although both Ropeg and Pegasys belong to the interferon drug class, Pegasys contains significantly more molecular mixtures, making it less effective in treating PV compared to Ropeg. Lin emphasized that once Ropeg replaces Pegasys in the market, it is unlikely that Pegasys will regain its former position.

Originally developed by Roche for hepatitis treatment, Pegasys was later licensed to Pharmaand, which manufactured a ten-year supply in 2017, meant to last until 2027. However, Pegasys has since been widely adopted for rare blood cancers such as PV and essential thrombocythemia (ET), leading to a sharp increase in demand. Compounding the issue, Pharmaand failed to ramp up production in time, causing shortages in multiple countries, including Taiwan, nearly two years ahead of schedule.

According to the European Medicines Agency (EMA), the Pegasys shortage will persist until the second half of this year. The U.S. FDA has also announced that Pegasys supply will remain limited until Q4 of this year, with normal production expected to resume in 2026. Additionally, Canada’s Drug Shortages Report website projects that local shortages will continue until the end of the year.

The Pegasys supply crisis in Europe has already driven a surge in demand for Ropeg. PharmaEssentia quadrupled its initial supply to European distributor AOP last year, and shipments to Europe are expected to double again this year.

Resource: 全球血癌藥缺貨 藥華藥新品緊急供應歐美市場