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- 2026-05-15 17:24:22
- Company
- Interleukin inhibitor market doubles in 2 years
- by May 30, 2022 05:41am
- Sales of interleukin inhibitors that are used to treat autoimmune diseases such as psoriasis have increased over twofold in 2 years. 1st generation drugs including Stelara, Cosentyx, Tremfya, and Skyrizi have all shown even growth. Market analysts have evaluated that the use of IL inhibitors has increased with the steady expansion of their indications. According to the market research institution IQVIA on the 27th, the IL-17/23 inhibitor class market size had increased 41.4% YoY to reach ₩28.7 billion in Q1 this year. IL inhibitors, which are mainly used to treat psoriasis, can be classified into IL-17 and IL-23 class drugs. The first mover in the market, Stelara concurrently targets IL-12 and IL-23. Its developer Janssen then released Tremfya as a follow-up that solely targets IL-23. Abbvie’s Skyrizi is also an IL-23 inhibitor. Novartis’s Cosentyx and Lilly’s Taltz are IL-17 inhibitors. With the introduction of such latecomers, the interleukin inhibitor market continued to repeat its growth every quarter. Starting with ₩13.8 billion in Q1 2020, sales rose to ₩15.3 billion in Q2, ₩18.2 billion in Q3, and ₩18.4 billion in Q4. Quarterly sales exceeded ₩20 billion for the first time last year, and by the previous quarter, the amount more than doubled to reach ₩28.7 billion in just two years. Janssen’s Stelara continues to show high growth 10 years after its approval. Its sales in Q4 last year exceeded ₩10 billion in quarterly sales. Its sales in Q1 this year were ₩10.1 billion, a 33.7% YoY increase. The indication of Stelara was expanded from psoriasis to psoriatic arthritis to Crohn's disease, then ulcerative colitis. As a result, its yearly sales exceeded ₩30 billion for the first time last year. Stelara’s sales which had been ₩26.9 billion in 2020 rose 34.2% last year to record ₩36.1 billion. Other more effective latecomer drugs have been introduced to the market, but Stelara continues to exert its potential as the only drug indicated for Crohn's disease and ulcerative colitis. Stelara is followed by the IL-7 inhibitor Cosentyx. Cosentyx made ₩7.5 billion in sales in Q1 last year. This is a 32.7% YoY increase. Novartis had increased patient convenience with a self-administered Cosentyx Sensoready Pen formulation that has a concealed needle. Cosentyx is the first IL-17 inhibitor to expand its indication to ankylosing spondylitis. The drug may also be used in non-radiographic axial spondylarthritis that comes before ankylosing spondylitis. Janssen’s Stelara follow-on IL-23 inhibitor Tremfya raised ₩5.8 billion in sales in Q1. This is a 45.2% YoY growth from Q1 last year. Janssen is working quickly to expand the indication of its follow-up Tremfya to replace Stelara before Stelara’s patent expiry. Tremfya’s indication was expanded from psoriasis to psoriatic arthritis, and the drug also acquired approval as a treatment for palmoplantar pustulosis, an indication unique to Tremfya. Abbvie’s Skyrizi, a drug in the same class as Tremfya, recorded ₩3.5 billion in Q1 this year, growing 166.0% YoY compared to the same period of the previous year. Although the drug’s sales size may seem less than other drugs, its quarterly sales exceeded that of Taltz’s. Skyrizi was the last to enter the market among IL inhibitors. It is yet only approved to treat psoriasis and psoriatic arthritis. However, the drug has been carrying out aggressive marketing activities with the strength of its convenience in administration as it requires the least number of administrations. Lilly’s Taltz was the only IL inhibitor to show stalled growth. Taltz’s sales, which were ₩1.7 billion in Q1 last year, recorded ₩1.8 billion in Q1 this year, showing little difference. Quarterly sales of the drug had remained at a ₩1.7 billion ₩1.8 billion level. The IL-17 inhibitor Taltz has the same indication as the same-class drug Cosentyx but its sales have been overtaken by Cosentyx in the market.
- Company
- Samjin recently filed a request against Janssen Korea
- by Kim, Jin-Gu May 30, 2022 05:41am
- Samjin has challenged Janssen's patent for the treatment of pulmonary arterial hypertension (Micronized Macitentan). In the past, generic companies have challenged Opsumit patents in all directions, but it has resulted in failure, drawing keen attention to the success of Samjin's challenge. According to the pharmaceutical industry on the 26th, Samjin recently filed a request against Janssen Korea for a passive confirmation of the scope of rights for the Opsumit patent. Opsumit is currently protected by two patents. It is material patent that expires in March 2023 and a pharmaceutical patent that expires in October 2027. Among them, Samjin's strategy is to avoid the patent for the drug that expires in 2027 and then release the generic in time for the expiration of the patent for materials in March 2023. Interestingly, generic companies have challenged Opsumit patents in the past. Huons, Intro Biopharma, and Alboven Korea simultaneously requested a passive judgment on the scope of rights and invalidation of material patent for Opsumit in 2015, and a trial for invalidation of the patent for sanctions. But this challenge failed. All three companies were rejected in the invalidation challenge for material patents, followed by the voluntary withdrawal of material patents and the invalidation challenge for pharmaceutical patents. The only way to challenge patent for Opsumit is to avoid the patent. Opsumit is a treatment for pulmonary hypertension developed by Actelion. In Korea, Janssen Korea is selling it. It has grown into a product that generates 10 billion won in sales since it was approved in 2014. According to IQVIA, a pharmaceutical market research firm, Opsumit's sales were 16 billion won last year. It recorded 4.3 billion won in sales in the first quarter of this year.
- Company
- The release of Singrix for NIP is expected
- by Moon, sung-ho May 30, 2022 05:41am
- Since the launch of the new government, the shingles vaccine market, called "a vaccine that is filial to parents," has been fluctuating. This is why global pharmaceutical companies are expected to release blockbuster vaccines in Korea in the second half of the year at a time when shingles are widely expected to be included in the NIP. According to the pharmaceutical industry and the medical community on the 20th, President Yoon Seok-yeol made a campaign pledge to "free vaccination of shingles vaccine over 65" when he was a candidate, drawing keen attention to whether it will be implemented Currently, the shingles vaccines distributed in Korea are SK Bioscience's Sky Zoster and MSD's Zostavax. On top of that, GSK's Singrix, which was approved by the Ministry of Food and Drug Safety in September last year as a potential competitor, is scheduled to be released in the second half of the year. The vaccines of SK Bioscience and MSD, which are currently used on the market, are live vaccines that are inoculated once to those aged 50 or older, and the prevention effect is more than 60%. Sky Zoster is prescribed at hospitals and clinics at a price of around 100,000 won and Zostavax at around 100,000 won. If President Yoon Seok-yeol fulfills his pledge, chances are high that these shingles vaccines will be included in the NIP. With sales of shingles vaccines plunging due to COVID-19 over the past two years, the inclusion of NIP acts as a good news for these pharmaceutical companies. This is because if these shingles vaccines are included in the NIP, they can recover their fallen sales. Related companies are paying attention to whether to include the shingles vaccine NIP. According to drug research agency IQVIA, Sales of Sky Zoster and Zostavax last year fell to 18.2 billion won and 27 billion won, respectively, compared to the previous year. Sales in 2020 were 29.1 billion won and 43.2 billion won, respectively, with sales of both items falling 38% in common. "As President Yoon Seok-yeol announced that he would include shingles vaccine in NIP as a pledge at the time of the election, related companies such as SK Bioscience have no choice but to expect it to be another breakthrough at a time when clinical results are scheduled to be released in the second half." As GSK's shingles vaccine Shingrix is confirmed to be released in Korea in the second half of the year, the atmosphere in the hospital and hospital markets is expected to heat up even more. In the case of Shingrix, the prevention effect is more than 90%, which is excellent compared to the existing vaccine. It is an inactivated vaccine, so it needs to be injected twice, and it is expected to be more expensive than the existing vaccine. Since it is called a "good-for-nothing vaccine," it is interpreted that the fact that it is rather "high-priced" may serve as a competitiveness in the medical field. Director A of otolaryngology in Gyeonggi-do, an executive of the otolaryngology association, said, "Current clinical studies show that Shingrix has an outstanding preventive effect compared to existing vaccines," adding, "Personally, I've been waiting for Shingrix and a really good vaccine has been released. Thanks to the marketing of the filial piety vaccine, it can work positively for patients. GSK is in last-minute consultations with domestic pharmaceutical companies over sales and marketing ahead of the launch of Shingrix. The pharmaceutical industry predicts that domestic sales and marketing partners will be "GC Pharma," but related companies say that it has not been decided. Another domestic company official said, "With Shingrix joining Sky Zoster and Zostavax in the second half of the year, whether to apply NIP will act as another variable in the market," adding, "If the introduction of shingles NIP becomes a reality, it could act as another competitiveness for existing items."
- Company
- Expanded indication for Jardiance
- by jung, sae-im May 29, 2022 05:15pm
- The SGLT-2 inhibitor Jardiance expanded the indication to HFpEF. Beringer Ingelheim Korea and Lilly Korea announced on the 26th that Jardiance has been approved by the MFDS to expand its indication as a treatment for chronic heart failure regardless of left ventricular contraction function (hereinafter referred to as heart rate). Jardiance was approved by HFrEF last November. It is expanded by preserving the cardiac output rate, and it can be used to treat patients with chronic heart failure regardless of the cardiac output rate. Heart failure is divided into reduction, vigilance, and preservation according to heart rate. The ejection rate is reduced by less than 40%, the boundary is 40 to 50%, and more than 50% is considered conservation. There have been no drugs that encompass both reduction and preservation of the ejection rate. Jardiance has become the first and only drug in Korea. The number of heart failure patients in Korea is about 1 million, accounting for about 50% of all heart failure patients with HFpEF. Heart failure with preserved heart rate has a high prevalence rate and patients' prognosis is not good, but there have been no clinically effective treatments. Jardiance demonstrated efficacy and safety in phase 3 clinical studies of EMPEROR-Preserved in patients with cardiac output retention heart failure (HFpEF). Clinical results in 5,988 heart failure patients showed that Jardiance reduced the relative risk of hospitalization due to cardiovascular death or heart failure, a primary evaluation variable, in adult chronic heart failure patients with preserved heart rate, regardless of diabetes. Second-order evaluation variable analysis not only reduced the relative risk of first and re-admission due to heart failure by 27%, but also delayed the reduction of glomerular filtration rate (eGFR), an indicator of renal dysfunction. Jardiance's overall safety profile was consistent with previous clinical trial results. The standard for administration of patients with renal impairment in type 2 diabetes was also eased. Previously, patients with type 2 diabetes with eGFR of less than 60 ml/min/1.73 m could not start treatment with Jardiance. With this change, patients with eGFR 45ml/min/1.73m can also start treatment with Jardiance. In patients with renal impairment with chronic heart failure, Jardiance can be used if the eGFR is 20ml/min/1.73m or higher. This was set in the same way as the standard for patients with heart failure with reduced cardiac output, whose indications were approved in November.
- Company
- Lorviqua, which is about to be reimbursed, has settled
- by Eo, Yun-Ho May 29, 2022 05:15pm
- The third-generation ALK inhibitor Lorviqua has settled in the Big Five Hospital. According to related industries, Lorviqua of Pfizer Korea passed the Drug Committee of Big 5 (DC), excluding Seoul St. Mary's Hospital such as Samsung Medical Center, Seoul National Cancer Center, and Chung-Ang University Hospital. As the adequacy of insurance benefits was recognized by the Drug Benefit Evaluation Committee last month after passing the first HIRA Cancer Disease Review Committee in January, it is expected to be quickly linked to actual prescriptions if the registration of Lorviqua is confirmed. It remains to be seen whether Pfizer, the first developer of ALK anticancer drugs, will be able to increase its market share. This drug was designated as a rare drug in March last year, and in July, it was approved in Korea for use when Alecensa or Zykadia was previously treated with a primary ALK inhibitor or Xalkori and at least one other ALK inhibitor as a treatment. The third-generation drug, Lorviqua, can be an alternative to patients with subsequent resistance, such as the first-generation drug, Xalkori, and the second-generation drugs, Zykadia and Alecensa. If Xalkori was used in the primary therapy, Lorviqua could be used after the second generation drug, and if the first generation drug was used, Lorviqua could be used in the second. Until now, if resistance developed in secondary drugs, chemotherapy had to be used because there was no target treatment available. G1202R is the most common resistance mutation after second-generation drug treatment, and depending on the drug, F1174L (Zykadia), I1171T/N/S (Alecensa), and E1210K (Alunbrig) appear. Lorviqua works on all known resistant mutations. Lorviqua has added indications of primary therapy for non-small cell lung cancer in Europe. The approval was made based on the results of a phase 3 CROWN study. In this study, Lorviqua demonstrated improvement efficacy in indicators such as death risk and ORR compared to Xalkori.
- Policy
- Chong Kun Dang faces Hanmi due to Rivaroxaban 2.5mg
- by Lee, Tak-Sun May 29, 2022 05:14pm
- Riroxia 10mg, which was released five months before the expiration of the original material patent by Chong Kun Dang, dominated the generic market. Next month, capsule-type 2.5mg products will be listed, and it is expected to face off with Hanmi over the generic marketChong Kun Dang anticoagulant Rivaroxaban 2.5mg will be listed as the second generic drug after Hanmi. Since Chong Kun Dang has shown extraordinary affection for anti-coagulation oral new drugs, it is expected that it will also focus its efforts on low dose Rivaroxaban products. According to the industry on the 22nd, Riroxia capsules 2.5mg will be listed next month. The original Rivaroxaban product is Bayer's Xarelto. However, 2.5mg product could not be released because it still has a patent for its product and a patent for its use, and Hanmi Pharmaceutical and SK Chemical acquired generic for exclusivity. There is also a difference in adaptation of the low dose (2.5 mg) and other doses. If 10, 15, and 20 mg are also used for treatment such as treatment of cardiac venous thrombosis and pulmonary embolism, 2.5 mg prodcut is used for the prevention of cardiovascular disease like aspirin. Studies show that using Xarelto 2.5 mg with Aspirin relatively reduced the risk of death from stroke, myocardial infarction, and cardiovascular disease in adult patients with coronary artery disease or symptoms than Aspirin alone. Accordingly, Bayer, which owns Xarelto, also paid more attention to generic blocking than other doses, such as registering 2.5 mg patent and use patent separately in Korea. Hanmi Pharmaceutical and SK Chemical succeeded in invalidating and avoiding 2.5mg of patents, respectively, and through this, they obtained generic for exclusivity. When the material patent was terminated in October last year, other pharmaceutical companies were not able to release 2.5mg products, but Hanmi, which acquired generic for exclusivity, was able to release the product. Currently, Original Bayer and Hanmi Pharmaceutical are the only pharmaceutical companies that have registered Rivaroxaban 2.5mg products. Chong Kun Dang could have been released in October last year if it had solved the original patent. Chong Kun Dang products are capsule formulations and are different from those of Korea. It seems that the registration was belatedly promoted because the patent for use was still in existence at the time. Currently, the Korean Supreme Court has ruled that the patent is invalid due to the request from Hanmi, and the final registration is about to be invalidated. The patent for use also expires on the 7th of next month. Although Chong Kun Dang belatedly releases 2.5mg products, they are faster than other post-refining drugs. This is because Rivaroxaban 2.5mg tablets can be released only on July 4 when the generic for exclusivity period between Hanmi and SK ends. Chong Kun Dang is working harder than any other pharmaceutical company in Korea on anticoagulant oral medicine generics. Rivaroxaban's other products, excluding 2.5 mg, also reduced some of the indications related to prolongation of life and pushed ahead with the launch five months before the expiration of the material patent. Chong Kun Dang requested a trial to confirm the scope of rights to avoid material patents. The request for the trial was dismissed in July last year, and Chong Kun Dang appealed to the Patent Court. However, Chong Kun Dang explained that Bayer's application for an injunction against patent infringement requested by the Seoul Central District Court has been rejected based on the judgment that it does not infringe material patents due to reduced indications. Chong Kun Dang ranks first in the Rivaroxaban market. Chong Kun Dang is conducting marketing under the plan to expand the original anticoagulant drugs to local clinics as they remain only in prescriptions for hospitals. Riroxia 2.5mg, which is listed at this time, is also expected to launch a large-scale marketing by Chong Kun Dang. It is expected that they will make desperate efforts to fight against Hanmi, which dominated the late drug market. The drug price was also set at 700 won, the same as 2.5 mg of Riroxban in Korea and Hanmi. As it is a showdown between the Chong Kun Dang, which has the strongest sales power in Clinics, and Hanmi, fierce competition is expected.
- Company
- Janssen takes sole lead in the ₩50 billion PAH market
- by Kim, Jin-Gu May 27, 2022 05:56am
- Janssen Korea is solidifying its lead in the ₩50 billion pulmonary arterial hypertension market in Korea. Whether the company will be able to maintain the share it has built up so far after terminating the co-promotion agreement with Handok remains a large variable. ◆The market for the rare disease pulmonary arterial hypertension expands to record ₩50 billion According to the pharmaceutical market research institution IQVIA, the market size for pulmonary arterial hypertension treatments last year was estimated at ₩51.4 billion. This market is steadily expanding with the discovery of new patients. Sales in the market in Q1 this year recorded ₩13.8 billion, a 12% YoY increase from the ₩12.2 billion in Q1 last year. The market size increased 51% in the past 4 years from the ₩9.1 billion in Q1 2018. Change in sales trend of treatments for pulmonary arterial hypertension (Unit 100 million won, Data: IQVIA) Pulmonary arterial hypertension is classified by function into three groups by the World Health Organization (WHO). Class 1 patients may be administered calcium channel blockers (CCB) that are widely used for hypertension treatment. For conditions that fall into WHO Class 2-3 may use endothelin receptor antagonists such as ambrisentan, bosentan, macitentan, or prostacyclin analogs such as beraprost, epoprostenol, iloporst, treprostinil, selexipag. In some cases, erectile dysfunction treatments such as sildenafil and tadalafil are prescribed. ◆Janssen Korea settles as sold lead in the market with its 3 drugs By company, Janssen Korea was found to have the sole lead in the market. Janssen Korea’s share accounted for 47% of the entire market in Q1 this year, followed by Anterogen (18%), Jeil Pharmaceutical (11%), and GSK (11%). Picture of OpsumitJanssen Korea owns 3 types of pulmonary arterial hypertension treatments - Opsumit (macitentan), Uptravi (selexipag), and Tracleer (bosentan). Opsumit has the highest sales among WHO Functional Class 2-3 treatments. Since its release in 2016, sales had steadily increased to record ₩16 billion last year. The drug sold ₩4.3 billion in Q1 this year, which is a 112% YoY increase from the same period last year (₩3.9 billion) Janssen Korea’s other treatments are also showing even growth. Uptravi and Tracleer have all raised ₩1.1 billion in sales in Q1 this year. This is a 5% YoY increase from the sales made in Q1 last year. ◆Janssen Korea sets out to stand alone in the market…will it be able to shake off its competitors?… The interest is focused on whether Janssen Korea will be able to maintain its sold lead in the market. Janssen recently concluded its long partnership with Handok. Handok first introduced Tracleer to Korea in 2006. At the time, the company was in charge of domestic sales of the product that was produced by Actelion. Handok then also took charge of selling Opsumit in 2016 and Uptravi in 2017 that followed. Handok maintained the exclusive sales agreement for the drugs even after Actelion was acquired by Johnson & Johnson in 2017. However, Janssen Korea and Handok concluded their domestic co-promotion agreement at the end of last year. Therefore, Janssen Korea is now solely in charge of the drugs’ domestic sales. Janssen Korea is now left with the challenge of avoiding the pursuits of Anterogen’s ‘Remodulin (Treprostinil)’ and GSK’s Volibris (ambrisentan) on its own. Quarterly sales of major treatments for pulmonary arterial hypertension (Unit 100 million won, Data: IQVIA) Anterogen received approval for Remodulin in 2010. Although the drug did not show good performance earlier in its release, being an injection type with inconvenient administration, its presence and sales have rapidly increased since 2019. Remodulin's sales more than tripled in the past three years from ₩2.8 billion in 2018 to ₩9 billion last year, and then recorded sales of ₩2.5 billion in Q1 this year. In the case of GSK’s Volibris, sales rose 57% in three years from the ₩3.3 billion in 2018 to ₩5.2 billion last year. In Q1 this year, the drug raised sales of ₩1.4 billion, a 17% YoY increase from Q1 last year.
- Company
- Tremfya reimb. expanded to psoriatic arthritis
- by Eo, Yun-Ho May 27, 2022 05:56am
- The IL-23 inhibitor 'Tremfya’ is now applied insurance benefit in psoriatic arthritis. The Ministry of Health and Welfare issued a notice of amendment and extended the reimbursement standard of Tremfya as of the first of this month. With the amendment, Tremfya may now be reimbursed in patients with active or progressive psoriatic arthritis who show an inadequate response to TNF-α inhibitor or IL-17 inhibitor or need to discontinue the use of such drugs due to contraindication or adverse events. Psoriatic arthritis is a chronic progressive immune disorder that is accompanied by joint swelling (inflammation), enthesitis (inflammation where a tendon or ligament attaches to bone), dactylitis (severe inflammation in the fingers and toes), and pain in the hand and feet areas. No cure exists for psoriatic arthritis until now, and despite the availability of treatment options, many patients are experiencing symptoms that affect their ability to perform daily activities. Around 9% of psoriasis patients in Korea are known to develop psoriatic arthritis. Tremfya received approval as the first IL-23 inhibitor to treat active psoriatic arthritis in adult patients who had responded inadequately or were intolerant to disease-modifying anti-rheumatic drugs (DMARDs). Meanwhile, Tremfya was approved as a treatment for adult patients with plaque psoriasis in April 2018 and as a treatment for adult patients with palmoplantar pustulosis in May 2019, and the indications were applied insurance benefits in September 2018 and May 2021, respectively.
- Company
- Soliris to Ultomiris...generation shift picks up speed
- by Kim, Jin-Gu May 26, 2022 05:56am
- The generation shift between Handok’s paroxysmal nocturnal hemoglobinuria treatments Soliris (eculizumab) and Ultomiris (ravulizumab) is gaining speed. With Ultomiris quickly replacing Soliris, Handok’s strategy of checking the release of Soliris’s biosimilars is also being considered a success. ◆Sales of Soliris drop 75%… replaced by its follow-on Ultomiris According to the market research institution IQVIA on the 24th, Soliris’s sales in Q1 this year recorded ₩2.8 billion. This is a 76% drop from the ₩11.4 billion it had made in Q1 2021. However, the rise in Ultromiris’s sales more than made up for the reduced sales of Soliris. Ultromiris raised ₩9.6 billion in sales in Q1 this year, exceeding the reduction in sales seen with Soliris (₩8.6 billion). Quarterly sales of Soliris and Ultomiris (Unit: 100 million won, IQVIA) Ultromiris is Soliris’s follow-on drug that has reduced the number of required administrations. Ultomiris can be administered every 8 weeks as maintenance therapy after the initial dose. However, Soliris needs to be administered biweekly. The drug was developed by Alexion (now AstraZeneca) and Handok is in charge of its domestic sales. Ultromiris started generating sales in Q3 after the drug was listed for reimbursement in June last year. Ultromiris had been showing high performance since its reimbursement, generating ₩8.9 billion in Q3, then ₩10.7 billion in Q4 last year. Ultomiris drew much attention in the prescription field since its reimbursement listing. According to the Health Insurance Review and Assessment Service, Ultomiris received 47 applications for prior approval in the first month of June 2021 alone. Only 9 new applications for prior approval were filed for Soliris in the same period. Soliris and Ultomiris, which were both listed as ultra-high-priced drugs, require prior approval on their eligibility for insurance reimbursement. The institutions that apply for prior approvals must administer the drug within 60 days of receiving HIRA’s deliberation results. Ultomiris’s prior approval applications amounted to 67 in the second half of last year. New applications for Soliris’s prior approval in the same period were only 16. Among these, only 1 new application was filed for the prior approval of Soliris to treat PNH, the indication that is also held by Ultomiris. The other 15 new applications were filed for the treatment of atypical Hemolytic Uremic Syndrome, an indication not covered by Ultomiris. ◆Handok chose ‘speed’ over ‘price’ to contain the rise of its biosimilars Soliris(left), Ultomiris (right) Handok’s reimbursement listing strategy is also receiving attention with the speedy generation shift between Soliris and Ultomiris. Handok received marketing authorization for Ultomiris in May 2020. In the process of receiving reimbursement approval, the drug’s insurance price was set lower than the weighted average of Soliris (₩5,598,492), at ₩5,132,364 per vial. At the time, the interpretation that Handok focused on ‘speed’ rather than ‘price’ had prevailed. Ultimately, Handok succeeded in listing Ultomiris for reimbursement in only 10 months since it applied for insurance benefits in August 2020 as planned. It is interpreted that Handok made such a decision with Soliris’s biosimilars in mind. In Korea, Samsung Bioepis and Isu Abixs are currently developing Soliris biosimilars. Handok's strategy was to quickly register Ultomiris before the biosimilars in development enter the market, and drive prompt switching to the follow-on drug. From this year’s Q1 results, it is evaluated that Handok's fast registration strategy to contain biosimilars was successful to some extent with the rapid switching of Soliris to Ultomiris. PNH is a life-threatening rare blood disease characterized by the destruction of red blood cells by the complement component that is part of the immune system. Without treatment, 4 out of 10 patients die within 5 years after diagnosis. The survival rate of those who are treated with Soliris or Ultomiris has been found to improve to 95.5%. In Korea, around 200 patients suffer from PNH.
- InterView
- “Allowing safe use of JAK inhibitors over restrictions"
- by Eo, Yun-Ho May 26, 2022 05:56am
- Professor Ki-Jo Kim Nowadays, safety is as important as a drug’s efficacy. In particular, reaffirming the safety of drugs that require long-term administration post-approval is essential. JAK inhibitors, which have entered the market as an oral option to treat various autoimmune diseases such as rheumatoid arthritis and ankylosing spondylitis, have been embroiled in controversy since last year. In 2021, the US FDA had warned of increased risk of cardiovascular events and cancer on the use of Jak inhibitors, and the MFDS also issued a Dear Healthcare Professional Letter on the issue. In the end, the FDA decided to include the increased risk of major heart-related events, thrombosis, and death in the black box warnings. The risk is undoubtedly an issue that cannot be overlooked. The risk of cardiovascular disease is a common issue that tags all treatments used for chronic diseases, but more accurate judgment on this risk is needed for JAK inhibitors as some patients do certainly benefit from its use. Also, various factors including age and race need to be investigated. On this, Ki-Jo Kim, Professor of Rheumatology at Catholic University St. Vincent Hospital, lectured on the ‘'Management of Rheumatoid Arthritis considering Safety” at the KCR 2022 (the 42nd Korean College of Rheumatology Annual Scientific Meeting and the 16th International Symposium) that was held from the 19th to 21st. Dailypharm met with Professor Kim to hear about the efficacy and safety of JAK inhibitors. -Could you tell us about your lecture? When first introduced, JAK inhibitors opened a new paradigm in the treatment of rheumatoid arthritis. Its safety issue had risen last year with the announcement of the Oral Surveillance study results that showed that JAK inhibitors may increase the risk of some cardiovascular disease and cancer. This prompted a fierce debate in academic societies in the US, Europe, and Korea. I have reviewed and reevaluated relevant data, studied how to read the results and interpret the studies that followed, and investigated whether different JAK inhibitors showed different results for the presentation. -What was your conclusion? When looking into the ORAL Surveillance results in detail, data showed that the JAK inhibitors had a slightly higher risk of developing cardiovascular disease and cancer compared to TNF inhibitors. But in detail, even this slight difference was limited to North American patients aged 65 or older. Also, supplementary data in the paper showed that a higher proportion of North American patients in the study had a high risk of developing cardiovascular disease, due to factors such as being over 65 years of age, obesity, high blood pressure, diabetes, and various drugs intake, etc. In this sense, the high-risk patients in the North American patient group may have driven such results. The real-world data that followed studied all patients with rheumatoid arthritis. No difference was found in these patients, and there was no difference when patients aged 50 or older that had 1 risk of cardiovascular disease were extracted and investigated as in the ORAL Surveillance study. A tendency was there, but with no statistically significant difference. When considering these factors, the ORAL Surveillance study data may have shown a larger difference due to its various limitations and regional variations. .The FDA seems to be quite strict in monitoring the risk of cardiovascular events .I understand that it is that much of a serious issue, but also suspect the decision made for JAK inhibitors had been somewhat influenced by this tendency. I agree to a certain extent .Moreover, due to the recent COVID-19 pandemic and the rapid introduction of vaccines, many patients seem to have become more sensitive about safety, not only for the vaccines but for all drugs in general .This may be why the FDA made such preemptive measures based on just one study result .-The rising concern is that due to the issue, authorities may limit the prescription of JAK inhibitors to ‘patients that are unable to use Anti-TNF therapies.’ What is your opinion on this? It’s a shame .JAK inhibitors have the advantage of being an oral formulation .There is stress in receiving regular shots, especially in the case of intravenous agents .There are patients who clearly show an effect when prescribed JAK inhibitors .It’s not that the anti-TNF therapies are lacking in effect, it’s just about what better fits the patient .Some patients who seem fine and are well controlling their inflammations but complain of pain or bad conditions were relieved of their inconveniences with JAK inhibitors .All drugs have adverse reactions that are identified with the use in their respective indications .We carefully examine these to select an appropriate drug for each patient .I believe it is better to let the doctors in the field use their discretion for the safe use of JAK inhibitors rather than impose regulations and restrict its use to the second-line.
