BESREMi is a preferred, FDA-approved option for both symptomatic low- and high-risk polycythemia vera patients. In the polycythemia vera space, BESREMi faces competition from drugs like ruxolitinib, a JAK1/2 inhibitor, and hydroxyurea. However, BESREMi differentiates itself by being a potentially more tolerable, non-myelosuppressive therapy with a lower risk of treatment-related malignancies.
New York, USA, Feb. 20, 2025 (GLOBE NEWSWIRE) — BESREMi Achieves Strong Market Growth Amid Rising Demand for Polycythemia Vera Treatment
BESREMi is a preferred, FDA-approved option for both symptomatic low- and high-risk polycythemia vera patients. In the polycythemia vera space, BESREMi faces competition from drugs like ruxolitinib, a JAK1/2 inhibitor, and hydroxyurea. However, BESREMi differentiates itself by being a potentially more tolerable, non-myelosuppressive therapy with a lower risk of treatment-related malignancies.
DelveInsight’s “BESREMi Market Size, Forecast, and Market Insight Report” highlights the details around BESREMi, which is approved for polycythemia vera and in late-stage development for essential thrombocythemia and primary myelofibrosis. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
PharmaEssentia/AOP Orphan Pharmaceuticals’ BESREMi (ropeginterferon alfa-2B/AOP2014/P1101)
BESREMi is an innovative, monopegylated, long-acting interferon designed for extended activity in the body. Utilizing advanced pegylation technology, it allows for administration every two weeks or, with at least a year of hematological stability, every four weeks—providing flexible dosing to accommodate individual patient needs.
BESREMi’s unique mechanism of action targets the JAK2 V617F mutation, commonly found in polycythemia vera patients, making it a compelling treatment alternative. BESREMi promotes hematologic responses, reduces spleen size, and normalizes hematocrit levels while lowering the risk of leukemogenesis compared to cytoreductive therapies like hydroxyurea.
In the US, BESREMi holds orphan drug designation for polycythemia vera treatment in adults. BESREMi was approved in the U.S. in Q4 2021, leading to significant sales beginning in 2022. Before its US launch, the drug had been approved in the EU in 2019 and became available in Germany, France, and the UK in 2020. In April 2022, Italy’s National Health Service (SSN) granted reimbursement approval. Japan approved BESREMi in 2023, followed by approvals in Canada and Malaysia in 2024.
In February 2024, the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) have recently been updated to include BESREMi, as a preferred first-line cytoreductive therapy option for the treatment of adults with symptomatic, low-risk PV.
BESREMi gained US approval in 2021 with an annual price of more than USD 180,000, whereas in certain EU countries, annual pricing range from USD 60,000–110,000. To date, the drug has been approved in around 40 countries worldwide. Common side effects of BESREMi include flu-like symptoms, injection site reactions, fatigue, headache, nausea, anemia, and liver function abnormalities.
BESREMi has demonstrated strong efficacy, inducing complete hematologic responses, high clinical response rates, and significant molecular responses that may slow disease progression. It has also shown the ability to reduce the allelic burden of both JAK2 and non-JAK2 mutations, which are linked to disease advancement.
PharmaEssentia is committed to advancing MPN treatment through the ongoing development of BESREMi. Beyond polycythemia vera, the drug is being investigated for additional indications, including essential thrombocythemia, early myelofibrosis, chronic myeloid leukemia (CML), hepatocellular carcinoma (HCC), adult T-cell leukemia, and more.
In June 2023, PharmaEssentia Corporation announced that it had entered into an exclusive license agreement with Pint-Pharma GmbH for the registration and promotion of BESREMi in Brazil, Argentina, Colombia, Chile, Peru, Ecuador, and Mexico.
| Drug Name | BESREMi |
| Molecule type | Recombinant protein |
| Developer | PharmaEssentia/AOP Orphan Pharmaceuticals |
| Approval | US: 2021; EU: 2019; JP: 2023 |
| Primary indications | Polycythemia Vera |
| Mechanism of action | Interferon alpha-2 replacement |
| Route of administration | Subcutaneous (SC) |
Learn more about BESREMi projected market size for polycythemia vera @ BESREMi Market Potential
Polycythemia Vera is an uncommon condition characterized by a persistent increase in red blood cell count, often accompanied by elevated levels of white blood cells and platelets. It is the most frequently occurring myeloproliferative neoplasm and the only one specifically linked to excessive red blood cell production. In 2024, the estimated number of prevalent polycythemia vera cases in the United States was approximately 182,000, with around 73,000 individuals being asymptomatic, according to DelveInsight.
While there is no cure for polycythemia vera, various treatment options exist to help manage the disease and its complications. Treatment typically involves a combination of medical procedures, medications, and other therapeutic approaches. Currently, two FDA-approved drugs are available for managing the condition: JAKAFI and BESREMi, both of which are also approved in Europe and Japan.
The treatment landscape for polycythemia vera is evolving, with new developments shaping its future. According to DelveInsight, the market for polycythemia vera across the seven major markets is projected to expand from USD 1.9 billion in 2024, with a substantial CAGR through 2034. This growth is primarily driven by the emergence of novel therapies, improved early detection strategies, advancements in secondary care treatments, ongoing clinical research, and increasing awareness of the disease.
Discover more about the polycythemia vera market in detail @ Polycythemia Vera Market Report
Emerging Competitors of BESREMi
Due to its distinct mechanism of action compared to JAKAFI and BESREMi, Protagonist Therapeutics’ rusfertide has the potential to serve as an earlier-line treatment option for polycythemia vera. It may offer an advantage over existing polycythemia vera therapies, given the severe side effects associated with JAK inhibitors. Current data suggests that rusfertide could emerge as the new standard of care, as it significantly reduces the need for phlebotomy, which directly impacts patients’ quality of life.
Other key companies developing drugs in the polycythemia vera space include Italfarmaco (DUVYZAT), Ionis Pharmaceuticals (Sapablursen), Merck (Bomedemstat), Silence Therapeutics (Divesiran), and others. In the myelofibrosis space, key players include AbbVie, Merck, Geron Corporation, and MorphoSys. For essential thrombocythemia, Merck, and MorphoSys are prominent competitors.
Apart from these emerging drugs, BESREMi will get competition from the already approved drugs for respective indications. In the polycythemia vera therapeutic space, Incyte/Novartis’s JAKAFI is a tough competitor to BESREMi whereas if approved for myelofibrosis, it will get direct competition from GSK’s OJJAARA, BMS’ INREBIC, and others.
To know more about the number of competing drugs in development, visit @ BESREMi Market Positioning Compared to Other Drugs
BESREMi Patent Details
In January 2022, the US FDA informed the company that as the first sponsor of this drug to obtain marketing approval for this indication, the company is entitled to 7 years of orphan-drug exclusive approval for ropeginterferon alfa-2b for adults with polycythemia vera. The 7-year exclusive approval began on November 12, 2021, the date of marketing approval. The patent for BESREMi is expected to expire in 2034, allowing generics to enter the polycythemia vera treatment market and hint at a rapid decline in revenue.
Dive deeper to get more insight into BESREMi’s strengths & weaknesses relative to competitors @ BESREMi Market Drug Report
BESREMi Market Dynamics
The treatment landscape for polycythemia vera has evolved significantly, shifting from conventional approaches like aspirin, hydroxyurea, interferons, and phlebotomy to more advanced therapies, including JAKAFI (approved in 2014) and BESREMi (approved in 2021). BESREMi, an interferon specifically targeting the JAK2 V617F mutation, is now recognized as first-line cytoreductive therapy in the updated NCCN guidelines. Its advantages include achieving hematologic response, lowering leukemogenic risk, and offering a convenient long-acting dosing regimen. BESREMi has been approved in multiple regions, including the EU and the US, for polycythemia vera treatment, backed by strong clinical data demonstrating its effectiveness in hematocrit reduction and overall disease management.
In the polycythemia vera treatment space, BESREMi competes with drugs like ruxolitinib (a JAK1/2 inhibitor) and hydroxyurea. However, it differentiates itself as a potentially more tolerable, non-myelosuppressive option with a lower risk of treatment-related malignancies. Its long-acting formulation gives it an edge over ruxolitinib, which requires twice-daily dosing. Despite the competition, BESREMi has been well-received by both physicians and patients due to its manageable side effect profile and ability to address limitations associated with traditional treatments.
Since BESREMi is positioned earlier in the treatment pathway than JAKAFI in NCCN guidelines, it does not directly compete with JAKAFI. However, its ability to delay disease progression and reduce the need for JAKAFI could impact JAKAFI’s overall revenue.
BESREMi is expected to reach peak adoption in the US by 2027 before late-stage competitors like rusfertide gain a foothold. Our analysis suggests that BESREMi will maintain a competitive lead for at least five years before new entrants like rusfertide establish themselves. Furthermore, with BESREMi’s patent set to expire in 2034, the eventual introduction of generics could lead to a sharp revenue decline. The market dynamics are expected to shift in the coming years due to increased first-line use of BESREMi for polycythemia vera, the anticipated launch of a pen-device version, potential expansion into additional indications, and broader global availability.
Discover how BESREMi is shaping the polycythemia vera treatment landscape @ BESREMi Polycythemia Vera
Table of Contents
| 1 | Report Introduction |
| 2 | BESREMi: PharmaEssentia/AOP Orphan Pharmaceuticals |
| 2.1 | Product Overview |
| 2.2 | Other Development Activities |
| 2.3 | Clinical Development |
| 2.4 | Clinical Trials Information |
| 2.5 | Safety and Efficacy |
| 2.6 | Product Profile |
| 2.7 | Market Assessment |
| 2.7.1 | The 7MM Analysis |
| 2.7.1.1 | Cost Assumptions and Rebate |
| 2.7.1.2 | Pricing Trends |
| 2.7.1.3 | Analogue Assessment |
| 2.7.1.4 | Launch Year and Therapy Uptake |
| 2.7.2 | The United States Market Analysis |
| 2.7.3 | EU4 and the United Kingdom Market Analysis |
| 2.7.3.1 | Germany |
| 2.7.3.2 | France |
| 2.7.3.3 | Italy |
| 2.7.3.4 | Spain |
| 2.7.3.5 | UK |
| 2.7.4 | Japan Market Analysis |
| 2.8 | Market Drivers |
| 2.9 | Market Barriers |
| 2.10 | SWOT Analysis |
| 3 | Key Cross of Marketed Competitors of BESREMi |
| 4 | Key Cross of Emerging Competitors of BESREMi |
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