PharmaEssentia announced on the 17th that France’s National Agency for the Safety of Medicines and Health Products (ANSM) has officially issued a notice on March 14, 2025, regarding the growing shortage of Pegasys (Peginterferon alfa-2a). In response to the worsening supply issue, ANSM has implemented strict distribution management measures starting from the 17th and recommended PharmaEssentia’s Ropeginterferon alfa-2b (Ropeg) as the priority alternative treatment for patients with polycythemia vera (PV) who do not present with splenomegaly. This recommendation applies to both newly diagnosed patients and those continuing treatment.
ANSM emphasized that healthcare professionals should follow the latest treatment guidelines and carefully assess each patient’s individual needs. It also urged medical institutions to actively seek alternative therapies to minimize the impact of the drug shortage on patients, alleviate concerns related to the unavailability of Pegasys, and ensure continuity of treatment.
PharmaEssentia stated that Ropeg is its proprietary, innovative, long-acting interferon, which has already been approved and marketed in multiple countries, including the United States, Japan, mainland China, and key European markets for the treatment of adult PV patients. However, Ropeg had not been formally launched in France until now. With ANSM’s announcement, Ropeg officially enters the French market, marking an unprecedented commercial opportunity for the company.
PharmaEssentia further noted that in recent months, health authorities in Europe, the United States, Canada, and Brazil have successively reported interruptions in Pegasys supply. After Roche transferred Pegasys production and distribution to Austria-based Pharma& in 2021, Pharma& has faced production capacity challenges, resulting in ongoing shortages across multiple countries. According to ANSM’s announcement, Pharma& (the holder of the Pegasys marketing authorization) and Cheplapharm (its commercial operator) are still experiencing supply difficulties, with no definitive timeline for restoring Pegasys availability.
Earlier this year, the U.S. FDA officially announced the Pegasys shortage on January 24, 2025. Following this, the National Comprehensive Cancer Network (NCCN) in the United States updated its treatment guidelines, explicitly recommending alternative long-acting interferons, such as Ropeginterferon alfa-2b-njft (Ropeg), when Pegasys is unavailable. This endorsement by the NCCN has not only strengthened Ropeg’s leadership in the PV market but also accelerated its global market penetration. It is expected to influence insurance coverage policies in the U.S., prompting more physicians and patients to adopt Ropeg as their treatment of choice.
The designation of Ropeg as the priority alternative by ANSM, prior to its official commercial launch in France, highlights the strong local demand for the product and signifies a major breakthrough for Ropeg’s entry into the French market. It also demonstrates PharmaEssentia’s proactive strategy and its ability to swiftly respond to market changes and ensure timely, stable drug supply.
Meanwhile, PharmaEssentia’s medical team is working closely with leading international hematology-oncology experts to provide more comprehensive treatment solutions, enhancing both efficacy and convenience. As global demand for innovative PV treatments continues to rise, Ropeg is poised to further expand its presence in the global myeloproliferative neoplasm (MPN) market, establishing itself as the new standard in long-acting interferon therapy and benefiting even more patients worldwide.
Resource: 藥華藥血癌藥獲法國指定為Pegasys斷貨時優先替代方案
