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- 2025-12-23 19:28:43
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- Polivy’s reimb soon to receive CDDC review
- by Eo, Yun-Ho Nov 06, 2023 05:26am
- Whether progress will be made for the reimbursement of the lymphoma treatment ‘Polivy,’ which has applied for reimbursement again after changing its indication to the first-line, is gaining attention. According to industry sources, schedule coordination is underway for the review of the agenda of reimbursing Roche Korea’s Diffuse Large B-Cell Lymphoma (DLBCL) treatment Polivy (polatuzumab vedotin) by the Cancer Disease Deliberation Committee (CDDC), after completing opinion collection from academic societies. Polivy is the first-in-class ADC targeting CD79b that binds to CD89b, a protein expressed in the majority of B-cells, to induce apoptosis. The drug had applied for reimbursement with its first indication, as a third-line treatment in combination with standard BR therapy (rituximab-cyclophosphamide), in 2021, but failed to pass review by the Cancer Disease Deliberation Committee. The company resubmitted an application for its reimbursement in the first half of this year after extending its indication to the first line in November last year. In addition, the patient group Korea Alliance of Patient Organizations added its support, urging that for the prompt review of Polivy’s reimbursement at the CDDC level. On the 2nd, KAPO submitted a written opinion to the HIRA, requesting rapid CDDC review and reimbursement adequacy revaluation for Polivy. Therefore, whether Polivy’s reimbursement agenda will be submitted for review at the CDDC meeting scheduled for the 22nd remains to be seen. Diffuse large B-cell lymphoma is an aggressive type of hematological cancer and the most common form of non-Hodgkin's lymphoma. In Korea, the number of new patients diagnosed with DLBCL is estimated to be near 5,000 each year. As the most common form of non-Hodgkin lymphoma, DLBCL is an aggressive (fast-growing) type of lymphoma that requires immediate treatment. DLBCL is generally responsive to treatment as over half of the patients reach remission, however, 30% to 40% of the patients do not respond to the standard-of-care, R-CHOP, or experience relapse after first-line treatment. Its first-line indication was approved based on the Phase III POLARIX trial. In the POLARIX trial, all patients were followed for over 24 months, and at a median follow-up of 28.2 months, the risk of disease progression, relapse, or death was reduced by 27% with Polivy + R-CHP compared with R-CHOP alone.
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- Expansion of coverage for SMA treatment Spinraza
- by Nov 03, 2023 05:32am
- Biogen Korea held a press conference on the 2nd at the Conrad Hotel in Yeouido, Seoul to commemorate the expansion of the reimbursement standard for Spinraza, the first SMA treatment developed Differentiation between single-dose Zolgensma and oral Evrysdi “Spinraza welcomes relaxation of salary standards” Hyeongjun Park, Professor of Neurology at Gangnam Severance Hospital, gave a presentation on changes in the SMA treatment environment. Biogen's Spinraza, a treatment for spinal muscular atrophy (SMA) with the advantage of direct intrathecal administration and multiple administration, succeeded in easing the age limit for reimbursement. It showed the potential to differentiate itself from competing drugs such as Novartis' Zolgensma, a one-shot treatment, and Roche's Evrysdi, a PO drug. Biogen Korea held a press conference on the 2nd at the Conrad Hotel in Yeouido, Seoul to commemorate the expansion of the reimbursement standard for Spinraza, the first SMA treatment developed. In order to receive Spinraza coverage in Korea, patients with 5q SMA must be 5q ▲ genetically diagnosed with a deletion or mutation in the SMN-1 gene ▲ not using a permanent ventilator ▲ develop SMA-related clinical symptoms and signs under the age of 3 All criteria had to be met. Due to this benefit expansion, the age limit for children under 3 years old has been deleted. As a result, SMA type 3 patients who developed symptoms after the age of 3 can now begin treatment with Spinraza for which reimbursement is applied. This expansion of the reimbursement standard is considered to be one step ahead of competing drugs in dominating the SMA treatment market. Zolgensma, a one-shot treatment, works by inserting a functional replacement copy of the SMN1 gene into a carrier called a ‘vector’ and then delivering it to motor neurons in the body through intravenous injection. The disadvantage is that it is difficult to administer multiple doses to patients who cannot be treated with a single administration. Evrysdi, an oral medication, has a similar mechanism to Spinraza but has the disadvantage of not being able to be administered directly intrathecally. Park Hyeong-jun, a professor of neurology at Gangnam Severance Hospital, said, “Zolgensma can only be administered once, so if the patient has experienced the virus once, an immune response will occur, making multiple administrations difficult.” He added, “Due to the risk of an immune response, it is only administered to patients under 2 years of age.” He continued, “In the case of Evrysdi and Spinraza, there is no direct comparative study, so it is difficult to say which drug is better. The difference is that Spinraza can be administered directly intrathecally. Because Evrysdi is an oral medication, there is no guarantee that the drug will only go to the spinal cord when administered. “There may be a shortage of doses,” he added. He said that it is meaningful to see improvement in symptoms in a wider range of patients by lifting Spinraza's age restriction. Professor Park said, “It was getting worse, but it’s important to feel like it’s improving. The probability of a patient who cannot walk walking and a person lying down and rolling to the side are different. There are many patients whose movements gradually improve. “This is why we need Spinraza, a multi-dose drug,” he said, adding, “It is true that people are cautious because Spinraza is a drug that costs more than 10 million won per bottle, but it is meaningful that the scope of what can be done for patients has expanded due to this expansion of coverage.” Ultra-rare disease SMA, the advantage of Spinraza is that can be administered directly. SMA is a rare, genetic, neuromuscular disorder whose symptoms are caused by a deficiency of the survival motor neuron (SMN) protein caused by a damaged or missing SMN1 gene. People with SMA may have difficulty sitting, standing, and walking. SMA is a leading cause of death in infants and young children, affecting approximately 1 in 10,000 live births, and causes a variety of disabilities in patients older than their teens. It is classified into types 1 to 4 depending on the time of symptom onset. Spinraza is an antisense oligonucleotide (ASO) with a mechanism of action that continuously increases the amount of SMN protein. In order to deliver the treatment to the cause of the disease, it can be administered directly to the central nervous system where motor neurons are located through intrathecal injection therapy. Spinraza can be differentiated in administration method because it can be administered multiple times. The treatment has confirmed its continued effectiveness and safety profile across all ages and types based on clinical research data and real-world use evidence (RWE) accumulated through treatment for up to 8 years or more.
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- Cosentyx is approved for hidradenitis suppurativa
- by Eo, Yun-Ho Nov 03, 2023 05:32am
- 'Cosentyx' has entered the field for hidradenitis suppurativa where no other treatment option than ‘Humira’ had been available until now. Moreover, the company plans to immediately enter the market for the indication in Korea as well. According to industry sources, Novartis Korea recently submitted an application to the Ministry of Food and Drug Safety to extend the indications for its interleukin (IL)-17A inhibitor Cosentyx (secukinumab) to hidradenitis suppurativa (HS). Considering how the indication was approved by the US FDA on the 1st, the company is rapidly preparing to introduce the treatment to Korea. Cosentyx is the first interleukin inhibitor to receive approval for the hidradenitis suppurativa indication and is an achievement made in 10 years after Humira (adalimumab). Hidradenitis suppurativa is characterized by pain and skin lesions such as subcutaneous nodules, abscesses with sinus tract formation, and scars. Repeated inflammation and pus can cause odor, interfering with daily life and adversely affecting the patient’s quality of life. Hot and humid weather makes these symptoms worse, and when the initial inflammation and subcutaneous nodules worsen, sinus tracts can form to the inside of the skin and cause scarring. Its prevalence, which is around 0.00033-4.1% worldwide, has been increasing gradually. According to data from the Health Insurance Review and Assessment Service, about 10,000 patients were reported with hidradenitis suppurativa in Korea as of last year, but the actual number is estimated to be greater. Studies in North America and Europe showed that it occurs more commonly in women, but in Korea, it occurs more commonly in men. Cosentyx's approval was based on the results of the SUNSHINE and SUNRISE trials, which were the largest Phase III clinical trials conducted in the field of hidradenitis suppurativa. Study results showed that the proportion of patients who achieved clinical response (HiSCR50) for hidradenitis suppurativa was higher in the Cosentyx 300mg arm than in the placebo arm when administered every 2 or 4 weeks. Cosentyx for hidradenitis suppurativa is administered at a dose of 300 mg every 4 weeks, and the dose can be increased every 2 weeks if the patient shows inadequate response. In the SUNSHINE study, the percentage of patients achieving HiSCR was 44.5% in the Cosentyx arm, compared to a mere 29.4% in the placebo arm. The HiSCR achievement rates in the SUNRISE study were 38.3% and 26.1%, respectively. In addition, the Cosentyx 300mg 4-week treatment arm also showed a significantly higher HiSCR achievement rate than the placebo arm. In the SUNSHINE study, the HiSCR achievement rate in the Cosentyx 300mg 4-week treatment arm was 41.3%, but 29.4% in the placebo arm. In the SUNRISE study, the rates were 42.5% and 26.1%, respectively. In addition, as a result of exploratory analysis up to 52 weeks of treatment, the HiSCR rate of the Cosentyx arm was sustained through week 52 of the study.
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- Novartis Jakabi expands graft-versus-host disease coverage
- by Nov 02, 2023 05:35am
- Novartis Korea announced that Jakabi, a Janus Kinase (JAK) inhibitor, will be covered by insurance for the treatment of acute or chronic graft-versus-host disease from November 1. About 1 year and 6 months after Jakabi was approved for graft-versus-host disease indication in May of last year, insurance benefits were applied to patients aged 12 or older who did not respond sufficiently to previous corticosteroid treatment. Graft-versus-host disease is a disease that occurs after allogeneic hematopoietic stem cell transplantation when the donor's T cells recognize the patient's normal cells as foreign substances. A variety of symptoms appear across multiple organs and greatly reduce the patient's quality of life. Steroids are used as the first treatment, but there is a risk of various side effects. In addition, about half of patients do not respond to treatment and show dependence on steroids, which reduces the effectiveness of treatment. Jakabi is a targeted treatment that selectively inhibits JAK hyperactivity signals and acts on both JAK1 and JAK2, the main causes of inflammation and tissue damage in graft-versus-host disease. Jakabi acts as a mechanism to lower the excessive production of inflammatory cytokines that cause tissue damage in graft-versus-host disease and to suppress the expansion of T cells. Jakabi has proven its effectiveness in patients with acute graft-versus-host disease refractory to corticosteroids through REACH2,3 clinical studies. Kim Hee-je, a professor at Seoul St. Mary's Hospital (Department of Hematology), said, "Patients with hematological diseases who have suffered from severe acute or chronic graft-versus-host disease that occurs after allogeneic hematopoietic stem cell transplantation have not been able to establish a standard treatment after the failure of primary steroid treatment, so there is no effective treatment available. “There was no such thing,” he said. The professor added, "Jakabi's listing on the payroll means that for the first time, a treatment that will solve the unmet need for treatment that has not been addressed in Korea has been prepared for the first time, and at the same time, patients can receive effective treatment without financial burden." Lee Ji-Yoon, managing director of Novartis Korea's Blood and Oncology Division, said, "We are pleased that this reimbursement listing has laid the foundation for domestic graft-versus-host disease patients to receive treatment comfortably without financial burden." Managing Director Lee said, “We will continue to strive to provide better treatment opportunities for domestic graft-versus-host disease patients and create an environment where they can focus solely on treatment.”
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- Reblozyl can be prescribed in general hospitals in KOR
- by Eo, Yun-Ho Nov 02, 2023 05:35am
- Reblozyl, a treatment for myelodysplastic syndrome, can now be prescribed in general hospitals in Korea. According to industry sources, BMS Korea’s Reblozyl (luspatercept-aamt) passed the drug committees (DCs) of several medical institutions in Korea including Samsung Medical Center and Sinchon Severance Hospital. Reblozyl is indicated to treat anemia in patients who showed inadequate response to or are intolerant to treatment with an erythropoiesis-stimulation agent (ESA) who have ▲ very low- to intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS), or ▲ very low- to intermediate-risk myelodysplasia/myeloproliferative tumor with ring sideroblastic cells and thrombocytosis, or ▲myeloproliferative neoplasm with ring sideroblasts and thrombocytosis, or ▲ anemia in adult patients with beta-thalassemia who require regular red blood cell (RBC) transfusions. The starting dose is 1.0 mg/kg subcutaneously once every 3 weeks for myelodysplastic syndrome and beta-thalassemia. Reblozyl has a mechanism of action that induces red blood cell maturation by inhibiting hyperactivation of the Smad 2/3 pathway caused by TGF-β superfamily ligands. Reblozyl demonstrated efficacy in the Phase III MEDALIST trial. Study results showed that the proportion of patients in the placebo arm who achieved continuous blood transfusion (transfusion independence) for at least 8 consecutive weeks during the 24-week observation period was only 13% while 38% in the Reblozyl arm reached 38%. During the same period, the rates of achieving transfusion independence were 8% and 28% respectively for 12 weeks or longer, and 4% and 19% respectively, for 16 weeks or longer in the placebo and Reblozyl arm, When extending the period to 48 weeks, only 7% of patients in the placebo arm achieved transfusion independence for longer than 16 weeks, whereas in the Reblozyl arm, the rate was 28%. Meanwhile, myelodysplastic syndrome is a malignant disease that occurs in hematopoietic cells in the bone marrow. It is a geriatric disease whose incidence increases rapidly in people over 60 years of age. It is characterized by ineffective and dysplastic hematopoiesis in the bone marrow and a decrease in normal white blood cells, red blood cells, and platelets in the peripheral blood. The most common symptoms include fatigue, general weakness, and decreased exercise capacity due to anemia. In severe anemia, symptoms such as palpitations, shortness of breath, and chest pain may also appear and develop into acute myeloid leukemia. Due to different clinical manifestations and course of the disease in each subcategory, some people live stably for decades with only mild anemia, but others develop complications due to a decrease in red blood cells or develop acute leukemia and die within a few months.
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- Public petition filed for the reimb of Verzenio
- by Eo, Yun-Ho Nov 02, 2023 05:35am
- A public petition imploring the government to reimburse Verzenio for early breast cancer has been posted online for review. On October 31st, a petition was posted on Cheong Wa Dae’s National Petition Bulletin Board entitled ‘Petition requesting reimbursement for Verzenio (abemaciclip), a targeted treatment for early breast cancer.’ The petitioner introduced himself as a person whose wife is suffering from HR+/HER2- breast cancer and asked the government to promptly list Verzenio, which is virtually the only treatment option available for her condition, for reimbursement. Accordingly, attention is focused on whether the CDK4/6 inhibitor Verzenio, which recently reapplied for reimbursement after a failure, will be able to successfully be reimbursed. Apart from letrozole generics that are used as endocrine therapy, Verzenio is the only new drug for the HR+/HER2- subtype of breast cancer. The drug was first approved on November 18th, 2022 as an adjuvant treatment for adult patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence in combination with endocrine therapy. More specifically, a very limited range of patients with ▲ 4 or more positive axillary lymph nodes, ▲ 1-3 positive axillary lymph nodes, and a tumor size of 5 cm or larger, or ▲histological grade 3 disease, can receive treatment with Verzenio. Lilly applied for reimbursement immediately upon Verzenio‘s approval. However, the drug struggled from the first step to its reimbursement at HIRA's Cancer Disease Review Committee level. After a long wait of 6 months after submitting the application, the agenda was finally reviewed at the 3rd CDDC meeting that was held on May 3rd. However, Verzenio had unfortunately many contestants. A total of 9 items were reviewed in the 3rd CDDC meeting. This was the largest amount of subjects among the 7 cancer screening meetings held this year. Five months after the first CDDC review, Lilly filed for reimbursement again on October 4th to the Health Insurance Review and Assessment Services. The company was equipped with new supporting data presented at the 2023 ESMO Congress that had been held in Madrid, Spain recently. The 5-year morachE data that was released was a follow-up study of the 4-year data released at the San Antonio Breast Cancer Symposium published in Lancet Oncology in December 2022. Study results showed that the differences in the major clinical indicators - invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) rates – widened more distinctively between the Verzenio arm and the control arm (endocrine therapy alone) at 5 years compared to 4 years. At 5 years, the primary efficacy endpoint IDFS differed by 8%. This means that even after completing Verzenio treatment during the limited period of 2 years after surgery, its treatment effect continued until the 5th year. This data is even more significant as the term, ‘cure,’ is generally used 5 years after cancer treatment.
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- Daewoong-Merck pursues full-cycle AI-based new drug dev
- by Lee, Seok-Jun Nov 01, 2023 05:40am
- Daewoong Pharmaceutical announced on the 31st that it had signed a memorandum of understanding (MOU) with Merck Life Science for the ‘establishment of an AI-based new drug development platform and full-cycle technical support of new drug development.’ The companies will work together to improve the efficiency and productivity of the new development process. Under the MOU, Merck will provide the data and programs necessary for the drug development process, and Daewoong will incorporate them into its web-based modeling platform for drug candidate discovery, verification, and monitoring. Merck will become the first in the industry to use AI (artificial intelligence) to support the technology necessary for the ‘entire cycle’ of new drug development. Daewoong Pharmaceutical will utilize Merck’s ‘SYNTHIA™’ and 'AMS(Aldrich Market Select)’ to improve the efficiency of its drug development process. Daewoong Pharmaceutical has demonstrated its R&D capabilities by developing new homegrown drugs for 2 consecutive years, including the gastroesophageal reflux disease treatment 'Fexuclue' and the SGLT-2 inhibitor antidiabetic ‘Envlo.’ Through the MOU, the company plans to strengthen its competitiveness in R&D and spur the development of first-in-class global blockbuster drugs. Joon-Seok Park, Park Chief of Daewoong Pharmaceutical's Drug Discovery Center, said, “We expect the MOU to increase our efficiency in new drug research and lay the foundation for our growth into a global big pharma by widening the gap in our new drug R&D capabilities with other domestic competitors. Ji Young Chung, Head of Science and Lab Solutions at Merck Life Science, said, “Our MOU with Daewoong Pharmaceutica holds significance as it marks the first partnership in Korea forged to support AI-based drug development throughout its entire lifecycle.”
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- 5th JAK inhibitor released…heats up competition
- by Kim, Jin-Gu Nov 01, 2023 05:40am
- (clockwise from the upper left) Jyseleca, Cibinqo, Rinvoq, Olumiant, Xeljan The fifth product was released in the market for JAK inhibitors, an oral autoimmune disease treatment drug. The JAK inhibitor market, which has continued rapid growth recently, is expected to grow more rapidly due to the addition of the new product. Competition among products is also expected to intensify. While Olumiant (baricitinib), Xeljanz (tofacitinib), and Rinvoq (upadacitinib) are competing for the lead, the new entrants, Cibinqo (abrocitinib) and Jyseleca (filgotinib), are also heralding their pursuit. Quarterly prescriptions exceed KRW 10 billion… Olumiant, Xeljanz, Rinvoq in a fierce battle for the lead Industry sources revealed that Eisai Korea released Jyseleca on the 1st. With the addition of Jyseleca, a total of 5 JAK inhibitors are currently available in the Korean market. Following the release of Pfizer Xeljanz in 2015, Lilly’s Olumiant was released in 2019, and AbbVie’s Rinvoq in 2021. In July this year, Pfizer's second JAK inhibitor, Cibinqo, was launched, and then Eisai’s Jyseleca. JAK inhibitors are used for autoimmune diseases such as rheumatoid arthritis and atopic dermatitis. Its mechanism of action blocks inflammation, pain, and cell activation by suppressing inflammatory cytokines. The domestic JAK inhibitor market has been expanding rapidly. According to the pharmaceutical market research institution UBIST, outpatient prescriptions of domestic JAK inhibitors in Q3 this year reached KRW 10.7 billion, a 24% increase in a single year compared to the KRW 8.6 billion made in the same period last year. In particular, quarterly prescriptions exceeded KRW 10 billion for the first time in Q3. At this pace, the total outpatient prescriptions this year are expected to expand and exceed KRW 40 billion. Quarterly outpatient prescription of JAK inhibitors (Unit: KRW 100 million, Data: UBIST) The battle for the lead is also fierce. While sales of Xeljanz, which has kept the lead for a long time, have slowed down somewhat, Olumiant has jumped to the lead since Q2 this year. In Q3, Olumiant posted prescriptions worth KRW 3.7 billion. This is a 28% increase from the KRW 2.9 billion in Q3 last year. During the same period, Xeljanz’s prescriptions increased by 2% from KRW 3.6 billion to KRW 3.7 billion. However, the difference between Olumiant and Xeljanz prescriptions is less than KRW 40 million in Q3, making it unclear which will rise to the top again. On top of that, the third entrant Rinvoq, has also quickly increased its prescription performance and joined in the leading competition. In the third quarter, Rinvoq posted prescriptions worth KRW 3.1 billion. This is a 45% YoY increase from the KRW 2.1 billion posted in Q3 last year. fifth drug ‘Jyseleca’ is released…JAK inhibitor market expected to continue to grow The addition of Cibinqo and Jyseleca to the market is expected to further intensify competition in the JAK inhibitor market. Cibinqo was released with reimbursement in July to treat atopic dermatitis. In the first 3 months of its launch, prescription sales amounted to approximately KRW 260 million. Jyseleca was newly released on the 1st of this month. It is an adenosine triphosphate (ATP)-competitive and reversible inhibitor that selectively inhibits JAK1. Quarterly major JAK inhibitor prescriptions (Unit: KRW 100 million, Data: UBIST) The JAK inhibitor market is expected to continue its high growth for some time due to the expansion of indications and the addition of new products. After first receiving approval as a treatment for rheumatoid arthritis, Xeljanz additionally received indications for psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. Olumiant first received approval as a treatment for rheumatoid arthritis, then added indications for atopic dermatitis and alopecia areata. Rinvoq was also first approved for rheumatoid arthritis and then added indications for psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, and ulcerative colitis. Cibinqo indicates atopic dermatitis. However, unlike other products, it can be used not only by adults but also by teenagers over the age of 12. The fifth product, Jyseleca, has indications for rheumatoid arthritis and ulcerative colitis.
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- Gilead aims for reimbursement of COVID-19 tx Veklury
- by Eo, Yun-Ho Nov 01, 2023 05:40am
- COVID-19 treatment Veklury is aiming to be listed on insurance benefits. According to related industry sources, Gilead Sciences Korea submitted an application for Veklury's benefit last month. As with Pfizer Korea's Paxlovid, the government plans to end the current free support system from the first half of next year, so it is believed that the reimbursement registration process will be followed accordingly. The government announced that it will pursue the registration of Paxlovid insurance benefits within the first half of 2024 in accordance with the plan to ease the COVID-19 crisis level adjustment roadmap. This measure is due to the fact that COVID-19 treatments, which are currently being supplied free of charge, are about to be converted to being supplied for a fee like general medicines. When stage 2 of the COVID-19 crisis level adjustment roadmap, which further relaxes the quarantine system, is implemented next month, COVID-19 will transform into a level 4 infectious disease like influenza (flu). In other words, the incorporation of medicines such as Veklury and Paxlovid into the general medical system becomes inevitable. The government said that even if the second stage roadmap is implemented, it will provide oral COVID-19 treatments free of charge for the time being, but it is unclear how long the free provision will last. Meanwhile, Veklury has a wider range of indications than Paxlovid. This drug was first approved in Korea in July 2020, and based on the current indications, it can be prescribed for children and adults, from mild to moderate patients at high risk of progressing to severe disease to patients with severe pneumonia requiring supplemental oxygen treatment. do. Gilead's application for reimbursement was also made for all currently approved indications for Remdesivir.
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- Global biosimilar market worth KRW 3.9 tril…Pfizer vs Amgen
- by Kim, Jin-Gu Oct 31, 2023 05:35am
- Prospects of the global biosimilar market have shown that the global biosimilar market, which is currently worth USD 28.62 billion (about KRW 39 trillion), will expand rapidly to reach USD 76.51 billion (about KRW 102 trillion) by 2028. On the 30th, the Korea Biotechnology Industry Organization made the forecast, citing biosimilar market data from global market research firm Frost & Sullivan (F&S). According to KoreaBIO, the global biosimilar market is expected to grow 17.8% a year until 2028. In particular, market size is expected to grow in earnest with the release of Humira (adalimumab) biosimilars this year. The global market size is expected to expand to USD 42 billion by next year, to USD 50 billion in 2025, to USD 60 billion in 2027, then to USD 70 billion in 2028. This is because the patents of global blockbuster drugs will be successively expiring during the period. The patents for Eylea, Stelara, Victoza, and Humira will expire this year, the patents for Xolair and Simponi in 2024, the patents for Prolia, Soliris, and Yervoy in 2025, the patents for Perjeta and Cyramza in 2026, then the patents for Trulicity in 2027. In 2028, patents for Keytruda, Opdivo, and Cosentyx are also set to expire. Currently, more than 400 companies are competing in the global biosimilar market. As of last year, the top 5 companies' share in the global biosimilar market reached 22.1%. Pfizer accounts for 8.4%, Amgen 4.9%, Eli Lilly 3.6%, Biogen 2.7%, and Teva 2.6%. In addition, Merck, Boehringer Ingelheim, Fresenius Kabi, Sandoz, Mylan, Biocon, Novo Nordisk, Celltrion, and Samsung Bioepis are competing with the top 5 companies in the North American and European markets. In the largest markets - the US and Europe - 40 and 64 biosimilars were approved, respectively, as of last year. In the case of Humira biosimilars that are attracting attention, 9 of the 10 companies that received approval released their biosimilar products in the U.S. market. In Europe, 10 companies have received approval for their Humira biosimilars. In Europe, in addition to Humira, biosimilar competition is fierce for Avastin (bevacizumab), Neulasta (pegfilgrastim), and Neupogen (filgrastim). 8 companies were approved for their Avastin and Neulasta biosimilars, and 7 companies were approved for their Neupogen biosimilars. Korea and Japan are leading the biosimilar approval and manufacturing in the Asian market, with India and China rapidly catching up. India has the most number of approved biosimilars in the world, with the count currently at 127. This surpasses the number of those approved in Germany and the United States. China has also emerged as a major country in biosimilar R&D recently. Currently, more than 60 pharmaceutical companies in China are developing biosimilars.
