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- 2025-12-25 19:20:52
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- GS Cross’s Neulapeg sales jump fivefold in 3 years
- by An, Kyung-Jin Aug 31, 2021 06:14am
- The locally developed neutropenia treatment ‘Neulapeg’ is enjoying its belated prime. The drug, which was unable to make a presence earlier at the time of its release is continuing to break new records every quarter since signing a sales partnership with Boryung Pharmaceuticals. Neulapeg’s quarterly sales have risen over fivefold in the past 3 years, and are attempting to overtake the market leader position held by ‘Nelasta.’ According to the pharmaceutical market research institution IQVIA, sales of GC Cross’s ‘Neulapeg’ increased 64.8% YoY to reach ₩5.4 billion in Q2. Compared to Q2 2018, quarterly sales of the product increased over fivefold. ‘Neulapeg’ is a neutropenia treatment made with pegfilgrastim that was developed with GC Cross’s original technology. The drug is used on cancer patients during chemotherapy to prevent side effects of decreasing immunity that occur from a decrease in the neutrophil level. It received marketing authorization from the Ministry of Food and Drug Safety in August 2014 and began its sale in March of the next year. ‘Neulapeg’ applies the PEGylation technology that conjugates polyethyleneglycol to specific areas to improve the purity, stability, and half-life of the drug over existing therapies. Neulapeg is considered a 2nd generation drug as may be administered only once per chemotherapy cycle to see an effect compared to existing neutropenia treatments that are administered 4-6 times per cycle. Despite its strength of being nearly ₩300,000 cheaper than Kyowa Kirin’s ‘Neulasta(pegfilgrastim),’ Newlapeg wasn’t able to make much of a presence earlier at the time of its release. In its third year, 2017, Neulapeg had sold ₩3.2 billion, and then ₩4 billion in 2018. Quarterly sales of Neulapeg, which was less than ₩1 billion, started to soar after Boryung Pharmaceutical joined in as a sales and marketing partner with GC cross. In Q4 2018, its sales jumped from ₩1.1 billion to 1.3 billion in the following quarter, 1Q 2019, and then continued upwards ever since. GC Cross had signed a joint sales agreement for ‘Neulapeg’ with Boryung Pharmaceuticals in October 2018. GC Cross had attempted to work with Boryung and utilize the company’s sales capability in the field of anticancer to expand its share in the neutropenia treatment market. According to IQVIA, Neulapeg accumulated sales of ₩8.9 billion in 2019. This is a 123.4% growth in sales in just one year after its partnership with Boryung Pharmaceuticals. Last year, despite the spread of the COVID-19 pandemic, it increased its market share by twofold and raised ₩15 billion in sales. This is a fourfold expansion in annual sales compared to 2018, before signing a partnership with Boryung Pharmaceuticals. And the company is continuing to make new records, earning ₩4.9 billion in Q1, and ₩5.4 billion in Q2. Cumulative sales in 1H of this year were ₩10.2 billion, a 62.8% increase from the previous year. On the other hand, Neulasta sold ₩12.3 billion, a 0.2% decrease from the previous year. This has narrowed the gap between the two products to ₩2.2 billion. If this trend continues, experts believe the position of the two products may be reversed within this year. On the other hand, Dong-A ST’s neutropenia treatment ‘Dulastin, which was released at a similar period as GC Cross’s Neulasta, has still been unable to mark a presence in the market. Dulastin sold ₩1.5 billion in 1H this year. Until 2018, the drug had made sales similar to Neurapeg. However, due to Neurapeg’s sudden and rapid growth in sales, the sales gap has widened to around 7 times. Dong-a ST had received marketing authorization for Dulastin in August 2014, and has started selling it in March of the following year. Dulastin is a second-generation G-CSF derivative that was applied to the company’s own extended-release technology for longer action. Its extended-release technology allows for the drug to stay in the blood for a longer period of time, which allows patients to administer the drug only once per chemotherapy cycle. ‘Lonquex (lipegfilgrastim),’ another second-generation neutropenia treatment that was released in 2016, is also not seen much sales for many years. Longquex sold ₩1.5 billion in 1H this year. This was a 6.2% YOY increase. Lonquex is a molecular structurally improved G-CSF that was developed by applying Handok Teva’s unique PEGylation technology. It is also administered once per chemotherapy cycle.
- Company
- Dong-A strengthens line-up with Sanofi's Actonel sales
- by Aug 31, 2021 06:13am
- Dong-A ST is expected to create synergy with its item Teribone by taking charge of the sale of Sanofi's osteoporosis treatment, Actonel. Dong-A ST will supply Sanofi-Aventis' osteoporosis treatment, Actonel, starting in October. Actonel is a bisphosphonate-based treatment that inhibits bone absorption. Since its launch in 2003, it has ranked 1st and 2nd in market share, but the amount of prescription has been gradually decreasing due to the emergence of new drugs and changes in treatment strategies. It has been out of stock due to issues such as relocation of manufacturing plants. Sanofi stopped supplying Actonel 5mg due to low sales in April, and stopped supplying Actonel 35mg this month. There are Actonel 5mg, 35mg, 150mg and Actonel EC 35mg. Dong-A ST will continue supplying Actonel that Sanofi gave up. Dong-A ST is planning to resupply Actonel from October after changing permission. Dong-A ST is selling Teribone, a bone formation promoter introduced by a Japanese pharmaceutical company. Although it made ￦260 billion in sales in Japan as of 2014, it is not up to ￦2 billion in Korea. Dong-A ST analyzed that Actonel and Teribone will create synergy effects. Although a remarkable new drug has recently been released, bisphonate preparation is still a standard treatment option. "We expect good synergy with the bone absorption inhibitor Actonel and the bone formation promoter Teribone," a company official said.
- Company
- A lawsuit is scheduled to be filed against the price system
- by Nho, Byung Chul Aug 30, 2021 05:55am
- It is expected that a number of domestic and foreign pharmaceutical companies will file an administrative lawsuit to defend the lowering of the drug price due to the change in the drug price system. Due to the revaluation of the drug price system, 475 items will be reduced in batches starting next month, and the annual economic loss of pharmaceutical companies is estimated to be up to 90 billion won. According to the industry, some domestic and foreign pharmaceutical companies are discussing specific measures with large law firms to cope with the loss of drug prices due to changes in the drug price system. A multinational pharmaceutical company is said to have filed an administrative lawsuit against the MOHW or the HIRA through law firm A to respond to the revision of the additional reassessment, which is scheduled to take effect on the 1st of next month. The pharmaceutical company wants to sue the MOHW because it is ineffective to apply for mediation due to all economic losses since the additional system has already been abolished. In the supply negotiations between the NHIS and pharmaceutical companies, there is a provision that fines will be imposed if the supply of the drug is not smooth due to the drug reduction. Many legal experts say, "Even if there is no immediate disposition, the requirements of administrative litigation will be met if economic disadvantages and rights infringement are certain in the future." In particular, the legal community said that there is a possibility of suspension of execution and winning the lawsuit against the original bill. The industry reported the purpose of the lawsuit that ▲ Violation of trust protection principles under the Administrative Act ▲ Significant loss of sales occurred due to the drug reduction, which was linked to a reasonable interpretation. There was a precedent in which the administrative court accepted the suspension of execution of pharmaceutical companies, citing the regulation under the Administrative Procedure Act that "Trust in administrative actions implemented by administrative agencies should be maintained and protected." In addition, clear evidence data of applicants due to drug reductions are expected to play an important role. 70% of originals, 68% of generic and raw materials, and 59.5% of generics have been applied to the system. If the generic is first registered, it will be given a pharmaceutical product for the first year, and if the pharmaceutical company produces the same ingredient product less than three companies, it will be able to maintain the additional product without limitation until more than four companies are registered. The additional period of this month's notice is limited to three years, and the HIRA's judgment extends up to two times a year, effectively up to five years. It seems to be due to the superficial interpretation that "the risk of supply has been extinguished due to the stable supply of medicines for 10 years after the system was implemented." However, the reason for the stable supply of the drug to date was because of the preservation of the drug price. The smooth supply of drugs correlates with drug prices and cost rates. "This revision notice could interfere with the stable supply of medicines," said an official of company A, who is considering a lawsuit. "IThe use of guidelines to cut drug prices up to the relatively low-cost line can be a good alternative so as not to commit the right to lose the opportunity to treat the public."
- Company
- Entry of generics halt Nexavar’s sole lead in liver cancer
- by Kim, Jin-Gu Aug 30, 2021 05:55am
- Product image of Bayer’s hepatocellular carcinoma treatment NexavarNexavar (sorafenib), which had been leading the liver cancer treatment market for over 10 years since its launch, has handed over its lead to ‘Lenvima (lenvatinib)’. This was a combined result of Nexavar’s drug price falling 30% due to the launch of its generics, and the rise in sales of its competitor Lenvima. Nexavar’s position in the liver cancer treatment market is expected to shrink further while competing with its generics as more products awaiting to enter the market. ◆1H sales of Nexavar drop from ₩10.3 billion to ₩5.6 billion… Impact of drug price cut According to the pharmaceutical market research firm IQVIA on the 28th, Bayer’s hepatocellular carcinoma treatment Nexavar recorded ₩5.6 billion in sales in 1H 2021. Compared to the ₩10.3 billion it earned in 1H of the previous year, sales fell 45%. In the same period, sales of Eisai’s Levima increased by 27%, from ₩ 5.7 billion to ₩7.2 billion. With sales of Nexavar plummeting and Lenvima significantly increasing, their shares in the market also changed. This is the first significant change observed in the market in 13 years since Nexavar was first used as a treatment for liver cancer treatment and 3 years since Lenvima was launched in Korea. Bayer had originally launched Nexavar in Korea in 2006 as a treatment for kidney cancer. Then, in 2008, it added the indication for hepatocellular carcinoma. The drug began to make real sales in 2011 after reimbursement was extended to the indication. Nexavar enjoyed exclusivity in the liver cancer treatment market for 10 years until Lenvima's release in 2018, earning over ₩20 billion in sales annually. However, the competition began after Lenvima was approved for reimbursement in 2019. In the beginning, Nexavar overpowered the market because the drug sequentially allows Stivarga and Cabometyx as follow-up treatments. However, Lenvima gradually increased its influence in the market and narrowed the gap with Nexavar with its improved clinical data. In February, Nexavar faced a direct hit, as its insurance ceiling price was cut by 30%. The government reduced Nexavar’s drug price ex officio by 30%, from the original ₩18,560 to ₩12,992, because Hanmi Pharmaceutical successfully launched its generic after overcoming Nexavar's patent. Quarterly sales of Nexavar and Lenvima (Unit: ₩100 mil, Data: IQVIA) ◆Competition intensifies in the market with the entry of Tecentriq and Nexavar generics Also, Nexvar's sales are expected to continue to fall for the time being. First, the drug price will be cut once more in early next year. Korea’s insurance drug price system mandates that the price of an original drug should be reduced by 30% at the time of a generic drug's release, then to 53.55% of the previous price 1 year after the generic is released. In addition, Roche's immuno-oncology treatment Tecentriq (atezolizumab) is about to enter the first-line treatment market for hepatocellular carcinoma. In February of this year, Tecentriq, in combination with Avastin, passed the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee as a liver cancer treatment. This means that reimbursement for Tecentriq is imminent. If approved, Tecentriq's entry into the liver cancer treatment market will only further narrow Nexavar's position in the market. Also, generic competitors await Nexavar. Hanmi Pharmaceutical overcame the patent for Nexavar and was approved for its generic Soranib. In the 5 months since release in February, the drug successfully landed ₩200 million in sales. Hanmi Pharm’s period of exclusivity rights expired at the end of July. However, the possibility that competitors from companies such as Kwangdong Pharmaceutical, which is also challenging Nexavar with its own generics, will add on to the competition remains. Kwangdong Pharmaceutical began a bioequivalence test for its generic last year.
- Company
- Cosentyx begins competition in the market
- by Aug 30, 2021 05:54am
- As Interleukin-17 (IL-17) sanctions enter the primary biological formulation benefit range for psoriasis arthritis, they will compete in earnest with TNF-α inhibitors. Cosentyx (Secukinumab) of Novartis expanded health insurance benefits from psoriasis arthritis to primary biological sanctions on the 1st. Cosentyx can be used if it meets certain conditions among active and progressive arthritis patients who are not effective in treating two or more types of DMARDs or who are difficult to treat due to side effects. The condition is for patients with three or more compressed joints and three or more edema joints. Previously, IL-17 regulations were paid only when TNF-α inhibitors were used first and used as secondary biological regulations in patients with insufficient response or difficulty in treatment due to side effects. This expansion allows Cosentyx to be prescribed in a position equivalent to the TNF-α regulation. Of course, it is not easy to compete with TNF-α drugs, which have long been widely used for autoimmune diseases such as psoriasis arthritis. In response, the interleukin formulation was intended to demonstrate superiority with head-to-head clinical trials. EXCEED studies, phase 3 clinical trial of Cosentyx, are typical. The effectiveness and safety of Cosentyx was compared as a control group with the representative TNF-α formulation, Humira (Adalimumab). The main evaluation item is ACA20 at week 52 of treatment, which represents a 20% improvement in arthritis. Clinical results show that the Cosentyx group and the Adalimumab group had a 67% to 62% ACR20 ratio, which resulted in Cosentyx absolute value, but did not satisfy statistical significance (p=0.0719). However, the rate of improvement in Psoriasis symptoms (PASI 90), a secondary evaluation variable, was significantly different from 65% to 43%. We also demonstrated significant improvements in the integrated evaluation variables ACR50 (more than 50% improvement in arthritis) and PASI100 indicators by 31% versus 19%. The percentage of patients who maintained treatment until the 52nd week was 86% to 76%, which was higher in Cosentyx. Shin Ki-chul, a professor of rheumatology at Boramae Hospital, said at a Cosentyx conference on the 25th, "Although ACR20 did not satisfy the statistical significance, it was different in ACR50 and it was more effective in ACR70. Of course, the primary indicator was set to ACR20 and the clinical design." The advantage of Cosentyx, which differentiates itself from conventional TNF formulations, is that it comprehensively treats the major symptoms of psoriasis arthritis. Cosentyx may be a priority consideration, especially in patients with spondylitis. International treatment guidelines have also changed accordingly. GRAPPA (Psoriasis and Psoriasis Arthritis Research and Assessment Group), a renowned international research group, recommends Cosentyx as a primary biological agent in the treatment of psoriasis arthritis, skin psoriasis, hand and toe psoriasis. The EULAR also suggested Cosentyx as the primary biological agent in arthritis and spinal arthritis in late 2019 and stated that it could be preferred over TNF inhibitors when there are related skin symptoms such as psoriasis. "The fact that IL-17 inhibitors are more effective in skin psoriasis than TNF preparations is now somewhat established. In addition, Cosentyx has the advantage of being able to control the dose from 150mg to 300mg. "It is reasonable to consider Cosentyx as the primary biological agent for psoriasis and other symptoms such as psoriasis." Competition with Taltz, which entered the primary benefit range at the same time, is also noteworthy. Paul Thomas, a medical director at Novartis Korea, said, "The study confirmed that Cosentyx is less likely to develop immunogenicity." Humanized antibodies are those that increase the similarity to human antibodies. Furthermore, human antibodies have no animal-derived parts, minimizing immunogenicity. Cosentyx is also attempting to enter primary biological sanctions in ankylosing spondylitis. Park Hye-yoon, executive director of the Novartis Transplant Immunity and Skin Disease Division, said, "We are trying to deliver good news in Korea as Cosentyx is being paid in most major countries such as the U.S., Canada, Japan and Australia under the primary regulation of ankylosing spondylitis."
- Company
- Shingles vaccine market overwhelmed by COVID-19… drops 60%
- by An, Kyung-Jin Aug 27, 2021 05:59am
- The domestic market for shingles is shrinking at a fast pace. With vaccinations for COVID-19 ongoing in earnest from earlier this year and the new ‘Delta variant’ intensifying the resurgence of COVID-19 cases, sales of the two shingles vaccines have dropped together. According to the pharmaceutical research institution IQVIA on the 26th, the shingles vaccine market in Q2 this year was ₩9.2 billion, a 59.1% YOY decrease from the ₩22.6 billion in the same period of the previous year. Sales had decreased 53.0% compared to the ₩19.6 billion in Q2 2019. Cumulative sales in 1H of this year have also decreased 42.2% from the previous year to record ₩20.1 billion. The shingles vaccine market in Korea consists of two products – MSD’s ‘Zostavax’ and SK Bioscience’s ‘SKYZoster.’ Its market had grown rapidly with the introduction of ‘SKYZoster’ in 2017 that broke the monopoly held by ‘Zostavax.' The local vaccine ‘SKYZoster’ had gradually increased its influence in the market, to rise and record ₩27.9 billion in Q4 2019. However, this shingles vaccine market that was once on a roll, is riding a rollercoaster of ups and downs after the COVID-19 pandemic. In Q1 last year, when COVID-19 started to spread, the market sales had halved to ₩12.2 billion. In Q2 of the same year, the market showed some signs of recovery, recording ₩22.6 billion, but then started falling again to ₩20.3 billion in Q3 and ₩17.3. billion in Q4. Entering this year, the drop became steeper, to record the lowest-ever sales since the two-drug competition structure was established in the market. The industry pointed out that the shingles vaccine market and other vaccine markets are more vulnerable to external factors such as pandemics, etc. than the chronic disease treatment market. Such vaccines are used to prevent a disease rather than be used in emergencies, therefore, the spreading reluctance to visit medical institutions naturally leads to a reduced vaccination rate. Full-scale inoculations with COVID-19 vaccines developed by multinational pharmaceutical companies including Pfizer and BioNTech, AstraZeneca, and Janssen have started earlier this year and have affected the decrease in the number of people receiving other vaccines. According to the Korea Disease Control and Prevention Agency, as of midnight on the 25th, a total of 26,701,704 people have received their first dose of a COVID-19 vaccine. This is around 52.0% of the total population in Korea. With the social atmosphere prioritizing COVID-19 vaccinations, Most of the vaccine market for adults, including the one for the shingles vaccine, is experiencing a slump. The two types of shingles vaccines -‘Zostavax’ and ‘SKYZoster’ – have shown a similar trend in their distribution of quarterly sales since last year. ‘Zostavax’ sold ₩5.4 billion in Q2 last year, which is a 57.9% YOY decrease from the same period of the previous year. This is also a 17.0% drop from the previous quarter, during which ‘Zostavax’ sold ₩6.5 billion. This year's cumulative sales in 1H were ₩11.9 billion, a 40.8% decrease from the previous year. Starting this year, MSD’s ‘Zostavzx’ has been marketed and sold by HK Inno.N in Korea. SKYZoster’s sales dropped 60.8% YOY to record ₩3.8 billion in Q2 this year. This is the lowest ever performance shown for the product other than in Q4 of 2017, immediately after its release. Cumulative sales of the first half of this year were ₩8.2 billion, a 44.2% decrease from the previous year. Not only in sales but SKYZoster’s market influence, which had skyrocketed ever since its release, has also decreased due to the pandemic. Based on cumulative sales of 1H, SKYZoster’s share in the market has decreased 1.4%p YOY from 42.2% to 40.8%. SK Bioscience expected sales of SKYZoster to recover in 2H with the increase of people who completed COVID-19 vaccinations and the start of the flu vaccination season.’ Also, another competitor is soon to be introduced to the domestic shingles vaccine market, forewarning more changes to come. Earlier this year, GSK has applied for the marketing authorization of its shingles vaccine, ‘Shingrix,’ to the Ministry of Food and Drug Safety. ‘Shingrix’ has been approved and is being sold in major countries around the world since 2017, when it was first approved by the U.S. Food and Drug Administration. Due to its high demand, the vaccine has been met with shortages in stock abroad. If sold in Korea, GSK’s ‘Shingrix’ in Korea may intensify competition and become a game-changer in the market.
- Company
- Korea Pharma has signed a contract to supply Accrufer
- by Aug 27, 2021 05:59am
- Korea Pharma announced on Monday that it has signed an exclusive contract with Shield Theapeutics to supply the anaemic drug Accrufer in Korea. Anemia is very common in patients with inflammatory bowel disease (IBD) and chronic kidney disease (CKD). Poor treatment of anemia increases the morbidity and morbidity of cardiovascular disease. According to Korea Pharma, existing oral anemia treatments have severe side effects such as gastrointestinal disorders and constipation. Since intravenous iron tablets require visiting hospitals once to three times a week, it takes time and is economically burdensome. Accrufer is an ideal alternative because it does not cause side effects such as gastrointestinal disorders and constipation, and absorbs as much iron as the body needs. Accrufer is a formulation that can replace the main used iron in the AEGIS-H2H study published in March 2019. Accrufer is expected to reduce the economic burden of intravenous iron preparations and improve patient conformity. Accrufer is approved by the FDA and EMA and is sold in Europe and the United States. It is the only oral anemia treatment in Korea that has been recognized for its excellent efficacy and safety with FDA approval. "Korea Pharma is a successful pharmaceutical company with outstanding performance in product development and commercial success," CEO Greg Madison said. "Iron deficiency is a global problem, and through this agreement, more iron deficiency patients in Korea will be able to use Accrufer in the near future," he said. Park Eun-hee, CEO of Korea Pharma, expects that the company will be able to provide iron deficiency treatment to Korea through Accrufer. Korea Pharma signed the world's first one-liter PEG bowel cleansing Plenvu exclusive contract with Norgine in December 2018, and this time it has expanded to IBD and CKD through Accrufer exclusive contract.
- Company
- Who will head Novartis Korea after Joshi Venugopal?
- by Eo, Yun-Ho Aug 26, 2021 05:58am
- The president of Novartis Korea is expected to change soon. According to industry sources, Joshi Venugopal, who had led Novartis Korea since September 2018, has completed his term at the end of last month and made a promotional transfer to become the Global Head of New Products at Novartis headquarters. Novartis Korea’s Chief Finance Officer, Kim Skafte Mortensen, has been running the company as the acting head since Joshi Venugopal’s resignation. Novartis is currently seeking a new head for its Korean subsidiary that will officially be appointed in coming October. Regarding the new appointment, some industry officials are cautiously mentioning internal rumors of a Korean national being appointed. Although Novartis has been operating its oncology and pharmaceutical division independently as a separate division, with reimbursement discussions for the CAR-T therapy ‘Kymriah (tisagenlecleucel)’ and SMA treatment ‘Zolgensma’ in progress, who will be appointed the new head is attracting much attention. Since its establishment in 1997 and the first president Frans Hompe, the company had mostly appointed foreign heads to lead the Korean subsidiary, including Jean-Luc Scalabre in 1998, Peter Maag in 2003, Andrin Oswald in 2006, Peter Jager in 2008, Brian Gladsen in 2014, and most recently, Joshi Venugopal. The only Korean national that had been appointed until now was Hak-sun Moon in 2015.
- Company
- GSK will supply Fluarix Tetra through Kwang Dong
- by Aug 26, 2021 05:58am
- GSK has signed a contract with Kwang Dong, which has disrupted discussions between SK Bioscience and Fluarix Tetra. GSK announced on the 24th that it has advertised and signed a joint sales contract with the flu vaccine Fluarix Tetra as a new partner. Initially, GSK discussed co-sale of Fluarix Tetra with SK Bioscience, which decided not to produce the flu vaccine "SKY Cellflu" this year. It seemed that the contract in the form of SK Bioscience sales marketing and receiving inquiries from hospitals and clinics in the consumer counseling office was almost finalized, but it was not contracted. GSK signed a contract with Kwang Dong. Kwang Dong decided to supply only a small amount of Fluarix Tetra to some hospitals, but it also decided to take charge of all the supplies SK Bioscience was planning to take. Kwang Dong will be responsible for the sale of Fluarix Tetra in all areas, including internal medicine, family medicine, orthopedic surgery, pediatrics and gynecology. GSK is expected to strengthen its expertise in distribution of influenza vaccines through the signing of this partnership. Yoon Je-young, brand manager of GSK's vaccine marketing department, said, "I think this contract will serve as an opportunity for Fluarix Tetra to be supplied and distributed more appropriately to the market."
- Company
- MSD’s Keytruda becomes the 'symbol' of cancer immunotherapy
- by Eo, Yun-Ho Aug 25, 2021 05:57am
- Pic. of Keytruda “Reinforcing the body’s immunity to attack cancer cells” By some, the idea was regarded improbable. Not many were convinced that immunotherapy would rise to the position it is in now. Even without reference to the famous story of how the former US president Jimmy Carter cured melanoma with immunotherapy, cancer immunotherapy has become an important pillar in the management of cancer disease nowadays. Among the many drugs introduced, MSD’s (Merck in the US) ‘Keytruda (pembrolizumab)’ has risen to become the symbol of ‘cancer immunotherapy.’ The drug, which was first approved in March 2015 as a treatment for melanoma, is currently approved for 18 indications in 14 cancer types in Korea. One thing to note is that Keytruda is yet far from reaching its turning point. ◆A neglected substance becomes an all-around anticancer drug Keytruda’s history goes all the way back to 2003. Keytruda was developed as a humanized antibody by Organon, a Dutch pharmaceutical Company. In 2007, Organon was acquired by Schering Plough, and the substance was approved for clinical trials by the FDA in December 2012. In 2014, only 3 years after trial approval, the company submitted a New Drug Application to the FDA and received approval as a treatment for melanoma in September of the same year. This was how Keytruda’s journey began. One interesting aspect to note is that MSD was not a prominent player in the field of oncology. The company, whose key areas focused on chronic disease, women’s disease, and vaccines, realized the potential of Keytruda and established a business division for the single drug. MSD’s insight and drive in making the decision to invest in a substance that was neglected by the initial developer is also one key strength of the company to note. After the initial melanoma indication, Keytruda was approved as a second-line treatment for non-small cell lung cancer in 2016, an area in fierce competition. Then, the drug became the first among cancer immunotherapies to receive approval as a first-line treatment for Stage 4 metastatic NSCLC. Afterward, by adding the combination therapy option to its treatment regiment, the drug’s indication was expanded from patients with high PD-L1 expression to all patients to position itself as the standard treatment option for all patients with metastatic NSCLC. Also, Keytruda transformed the concept of cancer treatment by becoming the first to be approved for ‘tumor agnostic' use in all cancer types based on specific genetic features regardless of the initial cancer site. In Korea, the drug was approved as a second-line treatment for 7 types of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, and more recently, as a first-line treatment for metastatic MSI-H/dMMR colorectal cancer. Keytruda ◆MSD Reaps rewards for its foresight… No.1 in sales in both Korea and the global market The company reaped rewards from its aggressive investment. Keytruda recorded No.1 in global sales in 2020, earning $14.38 billion (₩16.8 trillion as of August 18th, 2021). The same went for Korea as well. According to IQVIA, Keytruda recorded ₩155.7 billion in the domestic pharmaceutical market in 2020 to rank first among all pharmaceuticals in sales and has maintained the lead in the first half of this year. In the early years of its release, in 2016 and 2017, Keytruda sold around ₩10 billion’s worth; however, its sales hit ₩70 billion in 2018. The upsurge was driven by its reimbursement approval as second-line treatment for NSCLC in August 2017. As previously mentioned, much potential remains for Keytruda. MSD is conducting more than 1,400 global clinical trials focusing on Keytruda. Korea’s contribution is also quite significant in the area. Around 120 of the global anticancer therapy trials being led by MSD are being conducted in Korea and consist of around 88% of all trials conducted by MSD Korea. Based on the number of participating patients, Korea has ranked 1st among Asia-Pacific countries and 4th in global. ◆The remaining challenge...a rough ride to reimbursement extension However, obstacles do exist in Keytruda’s winning strides as well. Reimbursement is an issue as the insurance benefit is only approved for two indications, as second-line treatment for melanoma and lung cancer. The drug was not able to extend its scope of reimbursement since September 2017. In MSD’s discussions with the health authorities to reimburse Keytruda as second-line treatment for lung cancer, its competitor, the ‘all-comer’ drug ‘Opdivo (nivolumab),’ took away a partial win by strategically narrowing its scope of reimbursement, however, Opdivo also had not seen much progress in expanding its reimbursement ever since. The discussion for Keytruda’s reimbursement as first-line treatment in NSCLC has been ongoing for around 4 years now. It took 9 attempts for the agenda to pass the Health Insurance Review and Assessment Service’s Cancer Disease Review Committee (CDRC) meeting, however, the committee still requested further revisions to be made to the cost-sharing plan. With the burden of re-revisions in mind, MSD is waiting for the agenda to be put up for deliberation by the Drug Reimbursement Evaluation Committee. With the negotiations for contract renewal of the Risk-sharing Agreement (RSA) also overlapping, Keytruda is now at its highest inflection point since its entry into the Korean market. Due to its versatility, expanding the scope of reimbursement for Keytruda may indeed result in the creation of a budget-gobbling monster. In every field, the industry always moves faster than the system. Whether Keytruda will be able to continue making progress in the sea of unprecedented, advanced new drugs that are being introduced remains to be seen.
