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- 2026-05-13 21:14:56
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- Generic to pay for original’s lowered pricing loss?
- by Kim, Jin-Gu Nov 08, 2019 08:55am
- To this date, a boundary of patent infringement damage against generic was up to ‘sales profit of generic’. But now a lawsuit claims the damages should include ‘loss made from original’s price reduction’ due to generics’ launch. Related court case is currently waiting for the Supreme Court’s final decision. Lilly Korea and two Korean companies, Hanmi Pharmaceutical (“Hanmi”) and Myung In Pharm (“Myung In”), are tangled in a decade-long fierce dispute over patent covering Xyprexa (olazapine). Initially, Xyprexa’s patent was supposed to expire on Apr. 24 of 2011, but Hanmi and Myung In challenged the patent. Both ‘Intellectual Property Trial and Appeal Board’ and Patent Court ruled in favor of the Korean companies stating that the original’s patented invention lacks creativity. Based on the ruling, Hanmi and Myung In launched their generics in early 2011, a few months earlier than the challenged patent’s expiration date. At the same time, Xyprexa’s price was lowered by the government. Patent case gets a twist, litigation for damages immediately followed But, things got complicated as the Supreme Court overruled the previous decision stating the patent is still valid. The patentee, Eli Lilly, filed litigation for damages against the two Korean companies’ patent infringement. As a result, Hanmi and Myung In paid Lilly all sales profit made from the generic as damages. Typically, a patent infringement case concludes there. But Lilly did not stop and filed another case claiming the two companies should also pay for Lilly’s loss caused by the original’s price reduction. Lilly insisted Hanmi and Myung In’s early generic release had the original’s price to drop and hence, the loss from the price reduction should be compensated. Contrasting second trial, Supreme Court to make final decision in December at earliest The court gave a nod to some of Lilly’s claim at the first trial against each of the two Korean companies. But the second trial was ruled quite the opposite. The Seoul High Court dismissed Lilly’s claim on the case against Hanmi. Infringement of patent was recognized, but the court rejected damage claim on loss by drug price reduction. On the other hand, the Patent Court agreed with Lilly’s case against Myung In. The decision ordered Myung In to pay damages even for Lilly Korea’s loss generated by the original’s price drop. The court stated “The generic’s drug price listing application has directly affected government’s decision. And it brought Xyprexa’s price down to 80% of the original price”. The two contrasting decisions have been sent to the Supreme Court. Experts predict the court would make a decision by the end of the year. “The Supreme Court is reviewing legal principle and the issue comprehensively. The court decision would be out before next year,” a legal expert commented. More burden on early generic release if Lilly wins Actually, the damage amount alone for the two Korean companies was not that much. For instance, Myung In was ordered to pay damage of KRW 98.07 million from the first and second trials. The total sales were low to begin with, as the launch was only a few months ahead of the patent expiration. However, pharmaceutical industry’s patent experts view the decision on the litigation would significantly affect the industry. The court ruling in favor of Lilly would heavily influence early release of generics in the future. If patent infringement damages are to consist of generic sales profit and loss by the original’s price reduction, the damage amount could sum up astronomically and detrimentally depending on the generics’ release date. The Supreme Court’s final decision is soon to be made. As a matter of fact, Korean judiciary has never made a precedent ordering a generic manufacturer to pay for the original’s loss by price reduction. Now the public waits to see whether or not an exceptional decision would be made.
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- Carcinogen impact halves Zantac global sales
- by An, Kyung-Jin Nov 07, 2019 08:55am
- Suspected sales damage due to impurity found ranitidine came true for global pharmaceutical company Sanofi-Aventis’ Zantac. On Oct. 31, Sanofi reported global net sales of the company’s third-quarter 2019 rose by 1.1 percent over a year to EUR 9.5 billion (about 12.4 trillion won). Mainly driven by new atopic dermatitis treatment Dupixent, Sanofy Genzyme’s sales were up by 19.5 percent than last year same quarter, but Consumer Healthcare (CHC) sales contrasted drastically as it only grew about 0.4 percent. The company reported CHC global sales in the third quarter marked 1,136 million euro (about 147 billion won). Zantac is an original ranitidine medicine developed by GSK and is sold by Sanofi in the U.S. Canada and some other countries. Sanofi used to make Zantac sales of about 130 million euro sales annually. In each quarter the OTC drug used to make over 30 million euro, but this third quarter it only made about 14 million euro (about 18.1 billion won) with 58 percent drop from a year ago. The figure reflects Sanofi’s decision to voluntarily recall the products in the U.S. and Canada from last month. Sanofi Consumer Healthcare and Zantac’s global sales trend (Unit: € 1 million) Source: Sanofi On October 18, Sanofi officially made a statement about voluntary recall on Zantac OTC in the U.S. and Canada. The decision was made 37 days after the U.S. Food and Drug Administration (FDA) disclosed possibility of ranitidine medicine contaminated with N-nitrosodimethylamine (NDMA) carcinogen. Reportedly, Sanofi’s decision was mainly affected by ‘inconsistencies’ in preliminary test results of the API used in the U.S. and Canada products. However, the recall is limited to the two countries only as the API supplier varies in different regions. At the moment, recall on ranitidine medicine prescribed to Zollinger-Ellison syndrome patients in Columbia, Honduras, Guatemala, Ecuador and other Latin American countries is ongoing. Sanofi Chief Executive Officer, Paul Hudson, joining the conference call commented “As FDA raised concern over the safety of ranitidine medicine, Sanofi has decided to conduct precautionary voluntary recall on Zantac in the U.S. and Canada. Despite the negative issue in last quarter, CHC has maintained relatively stable sales”.
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- Scouting fresh face for CEO at merged BMS and Celgene
- by Eo, Yun-Ho Nov 07, 2019 08:54am
- Merged Korean branch of Korea Bristol-Myers Squibb (BMS) and Celgene has now high probability of bringing in a new chief executive officer from outside of the company. According to pharmaceutical industry, BMS and Celgene headquarters have agreed on scouting a CEO openly for the merged Korean office scheduled to open before next year. Reportedly, many of current and former pharmaceutical company CEOs in Korea have applied for the job, including the current 47-year-old Celgene Korea CEO Ham Taejin. The company associates views that the headquarters’ decision to make it a public recruitment could mean they are contemplating on hiring personnel currently unassociated with the company. Including the headquarter office, BMS and Celgene are in process of appointing CEOs for major regional offshoots. And merged regional corporations with new CEO are undergoing overall reorganizations. The Korean branch has appointed a new head for Regulatory Affair department, and other departments including Market Access, Government Affair and Public Relation are also expect some changes. More than anything, the company insiders confirmed the two companies have reached a fair agreement to reorganize the corporation regardless of who is acquiring whom. In last January, BMS announced acquisition of Celgene with a value of about USD 74 billion (about 86.4 trillion won). BMS was said to acquire Celgene in cash and stock equity, and pending merger is still ongoing after closing the agreement. Sources confirm, BMS and Celgene have mutually agreed to hire a new CEO for the merged corporation. Besides the CEO scouting, the two companies are working on reorganization of the merged company.
- Company
- Kisqali gets a nod from MFDS joining Ibrance and Verzenio
- by Eo, Yun-Ho Nov 06, 2019 09:00am
- Following the footsteps of Ibrance and Verzenio, a third CDK4/6 inhibitor announced its launch in Korean market. On Oct. 30, Novartis officially released news that Kisqali (ribociclib) has been approved by Ministry of Food and Drug Safety (MFDS) as a treatment of postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer. Ongoing competition between Ibrance and Verzenio, currently in insurance reimbursement review process as a combination therapy with Faslodex (fulvestrant), is to intensified even more. Kisqali was approved by the regulator as it demonstrated a meaningful improvement of prolonging progression free survival (PFS) from its clinical trial. Phase 3 MONALEESA-7 clinical trial evaluated Kisqali combined with endocrine therapy (either an aromatase inhibitor or ovarian function suppression) as first-line treatment for pre and perimenopausal women with HR+/HER2- advanced or metastatic breast cancer and proved the drug’s effect on significantly extending patient’s overall survival (OS). Professor Im Seock-Ah of Hemato Oncology Department at Seoul National University Hospital explained, “MONALEESA-7 study was mainly proposed and led by an Asian researcher, and had 30 percent of Asian patients as registered sample. This finding reflects how Asian region has a great need for a new treatment on premenopausal women with breast cancer”. In the Phase 3 MONALEESA-3, Kisqali proved to extend OS and demonstrated improved treatment efficacy when used as initial endocrine-based therapy in combination with fulvestrant for postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer in combination than using the existing endocrine-based therapy alone. The recommended dose of Kisqali is taking 600mg (three 200mg tablets) orally, once daily for 21 consecutive days followed by seven days off treatment. The treatment could be taken with or without food but at set time of the day. Meanwhile, Ibrance and Verzenio are waiting for deliberation by Drug Reimbursement Evaluation Committee (DREC) after Cancer Disease Deliberation Committee of Health Insurance Review and Assessment Service (HIRA) has passed both. Reimbursement review process of the both treatments started from same point of origin, cyclin-dependent kinase (CDK) 4 and 6. But their regulator review approaches are different. In November of 2017, Ibrance has already been listed as a first-line therapy (combination with Letrozole) via refund type risk sharing agreement (RSA). And now it is in process of expanding the reimbursed indication. Verzenio, on the other hand, is applying for reimbursement listing for the first time. The treatment has simultaneously applied for reimbursement not only as a second-line therapy, but also as a first-line therapy in combination with aromatase inhibitor. But under its current circumstances, Verzenio’s only option is RSA. Unfortunately, a follow-on drug is not yet eligible for RSA, so Lilly would likely to push on with the second-line therapy indication without any other drug available. Kisqali would also likely to take the same track.
- Company
- Korean companies competing for GSK’s OTC Drugs
- by Jung, Hye-Jin Nov 06, 2019 09:00am
- A pharmaceutical industry insider reported on Nov. 1 that three Korean pharmaceutical companies are competing against each other to acquire sales rights of ten popular over-the-counter (OTC) drugs manufactured by GlaxoSmithKline (GSK). The multinational drug manufacturer said it would soon decide on a partner company. In 2017, GSK signed a supply contract with Dong-wha Pharm for co-promotion and sales rights on ten OTC drugs including Lamisil, Otrivin, Voltaren, Nicotinell, Theraflu, Sensodyne, Breathe Right, Zantac, Polident and Driclor. The two companies’ contract was supposed to last until 2020, but as GSK and Pfizer Consumer Healthcare merged and established a new joint venture, the old contract is said to be terminated. Dong-wha Pharm recently announced that its OTC supply contract with GSK would be terminated on coming Dec. 31. As a result, GSK has been contacting several Korean pharmaceutical companies for a new partnership. Reportedly, GSK is in talks with three companies, including a well-known pharmaceutical company with strong pharmacy sales power along with a famous OTC drug. The pharmaceutical companies are proposing differentiated service fee rates based on sales performance and return policy to win the hearts of GSK for the sales right deal. As the multinational company’s OTC drugs are making about 60 billion won annually, a Korean company winning the deal would secure a stable cash cow. Sources report GSK is closely reviewing respective companies’ sales network, specifically their pharmacy sales power. Sales for OTC drugs are highly dependent on pharmacy sales power due to its nature. Some had predicted Dong-wha Pharm would terminate the contract by the end of the year and renew the contract from next year. But apparently the company is not included among the three candidate companies. However, some experts evaluate the ten popular OTC drugs would generate notable amount of sales, but it could be an unappealing deal to a distributor because of their low marketing margin. At the moment, Dong-wha Pharm is recalling Zantac with ranitidine and other nine items. A GSK official explained “For a new partner company to initiate distribution from January next year, the contract has to be signed before the end of the year. Insiders say the talks are wrapping up. The decision would be made very soon”.
- Company
- Is MFDS going to suspend sales on nizatidine with no NDMA?
- by Chon, Seung-Hyun Nov 06, 2019 08:59am
- Pharmaceutical industry is walking on thin ice as the government initiated impurity investigation on stomach ulcer medicine. Now that the U.S. detected impurity in nizatidine, following a case in Japan, probability of finding impurity in nizatidine has gotten higher in Korea. The industry is on high alert against the government’s possible order to suspend sales of nizatidine drug without detecting any impurity, which was the case with ranitidine. According to an industry insider, Ministry of Food and Drug Safety (MFDS) ordered pharmaceutical companies to submit complete nizatidine product manufacturing record and to test active pharmaceutical ingredient (API) chemically similar to the ingredient. MFDS ordered companies to submit API usage record and other archived evidences to confirm manufacturing record until Nov. 4. The ministry seems to be investigating uses of all complete product with both Korean-made and imported nizatidine Nizatidine is an H2-receptor antagonist similar to ranitidine suspended of sales from last September. After deciding to suspend sales of all ranitidine drugs, MFDS also set a plan to investigate similar APIs, starting with nizatidine first. Ministry’s nizatidine usage record investigation resembles that of ranitidine’s. On last Sept. 20, MFDS directed pharmaceutical companies to investigate ranitidine API usage record, and six days after on Sept. 26, the ministry announced sales suspension on all ranitidine items. The industry presumes MFDS is about to announce nizatidine investigation result based on the precedent case. And now, the industry is nervously waiting for the ministry’s decision on nizatidine items. .Possibility of finding N-Nitrosodimethylamine (NDMA) has been raised at home and aboard, already .A private U.S.-based research institute, Valisure unveiled their testing report on nizatidine last September and stated they have detected NDMA .Previously, Valisure proposed regulators to recall ranitidine as it detected excessive level of NDMA in the API .Their latest report state researchers found one-seventieth of NDMA in ranitidine was detected in nizatidine .Japanese Ministry of Health, Labour and Welfare announced Japan-based Ohara Pharmaceutical tested their nizatidine product and detected NDMA exceeding the accepted level .The ministry reported the company decided to voluntarily recall their products due to the issue .On Nov .4, the U.S .Food and Drug Administration (FDA) released a statement about their investigation on NDMA found in ranitidine, and stated four nizatidine items from two companies had NDMA .However, the said nizatidine drugs had NDMA within the accepted level and were not included in the voluntary recall subject group .Some of pharmaceutical companies in Korea are promoting that their nizatidine drugs are NDMA free .However, some have raised concern about possibility of detecting NDMA in nizatidine ingredient used in Korea .At the moment, total nine API manufacturing plants have been registered to produce nizatidine .Korean Medical Association (KMA) has already advised doctors to refrain from prescribing nizatidine .In last month, KMA official said “The recent ranitidine incident has created a social turmoil, so the organization advised members to refrain from prescribing nizatidine containing drugs until MFSD announces final investigation result and its further action” .Pharmaceutical companies are keeping a close eye on MFDS’ further action for when finding minuscule amount of NDMA in nizatidine .The companies are afraid of the ministry ordering sales suspension on all nizatidine drugs for questionable cases of NDMA not detected from most of the complete product, and a single manufacturing unit containing minuscule amount of NDMA exceeding acceptable level .As for ranitidine drugs, all seven manufacturing plants had NDMA surpassing acceptable level in the API, but each item manufactured in a same plant had different levels of NDMA .For instance, some ranitidine drugs manufactured from one plant were found with unacceptable level of impurity and others were not .Result of NDMA investigation on collected ranitidine API (Source: MFDS)At the time, MFDS official stated “After collecting issue API and investigating them, each registered items from one manufacturing plant had different levels of NDMA and similar cases have also been found in other countries” .After making the statement, the ministry ordered sales suspension on all ranitidine drugs, judging that ranitidine itself is too unstable to be consumed .A pharmaceutical research institute, UBIST reported last year’s volume of nizatidine drug prescription for outpatient reached 25.9 billion won .Although it would be about one tenth of the ranitidine market, some pharmaceutical companies are faced with serious damage from sales suspension on popular nizatidine products .Pharmaceutical companies continue to urge the Korean regulators to suspend sales limited to items exceeding acceptable NDMA level like the case in the U.S .Some of the industry is also questioning credibility of the NDMA testing methodology as same API has been detected with different levels of NDMA .A pharmaceutical industry insider stressed, “MFDS has decided to suspend sales on valsartan and ranitidine drugs, regardless of each sample showing different level of the carcinogen .The regulators should use more precise investigative methodology and limit penalty to items with exceeding level of NDMA only” .
- Company
- Biosimilar Ultomiris to follow Soliris next year at earliest
- by Kim, Jin-Gu Nov 04, 2019 03:12pm
- Sources predict Ultomiris would enter the Korean market and a competition against a blockbuster antibody, Soliris, next year. According to pharmaceutical industry on Oct. 30, the drug manufacturer of Ultomiris, Alexion is preparing for a launch in Korea at the end of next year. The follow-on antibody drug already has been approved by FDA in the U.S. and by EMA in Europe last December and July, respectively. Like the case with Soliris, Handok is highly likely to manage Ultomiris’ approval and healthcare reimbursement application in Korea, but sales and marketing company has not been decided, yet. Currently, Handok is in charge of Soliris’ sales and marketing in Korea. Both Alexion and Handok are hesitant to give a clear plan, as they are still working on Ultomiris’ approval in Korea first. An official from Handok said, “Handok would be handling Ultomiris’ application for approval and healthcare reimbursement listing. At this point, it is still too early in the process for both companies to discuss about approval application schedule in Korea” and “sales and marketing contract would be dealt with after they are handled”. Alexion insider hinted, “Specific schedule has not been set, yet, but we are aiming to get approval from Korea at the end of next year”. Now the title has been taken away, but Soliris used be called the ‘most expensive drug in the world’. In 2010, it costed 500 million won for a year-long treatment of Soliris. Worldwide sales marked USD 3.14 billion (about 3.59 trillion won). The patient size may be small but because of its extremely expensive price, the sales volume is still massive. However, Soliris is soon to face biosimilar competitors as its patent expiration date is approaching. In the U.S., Amgen has reportedly filed a suit invalidating patent for Soliris as a preparation for an early release of its biosimilars product. If Amgen wins the case, the original patent expiration in 2027 would be moved up as early as 2021. In Korea, Samsung Bioepis and Abxis are currently developing biosimilars. Prospective competitors expect their products to excel in the market considering the original cost 500 million won a year. Alexion’s Ultomiris launch prep is also closely related to the original patent case. The blockbuster original and the biosimilars have overlapping indication of ▲paroxymal nocturnal hemoglobinuria (PNH) and ▲atypical hemolytic uremic syndrome (aHUS). Also the market could favor Ultomiris over Soliris as number of annual injection is about a quarter of Soliris’. The original is supposed to be shot once every other week, whereas Ultomiris is shot once every eight weeks. Summing up a year worth of injections, Soliris and Ultomiris are shot 26 times and six to seven time a year (52 weeks), respectively. Accordingly, the drug expense for Ultomiris would be significantly lower. A global pharmaceutical industry analytic firm, EvaluatePharma has once evaluated Ultomiris’ market value at 10.9 billion dollars (about 12.26 trillion won). The figure is over a triple of Soliris’ global sales volume of 3.14 billion dollars.
- Company
- 3분기만에 1천억 '거뜬'...잘 나가는 K-신약 캐시카우
- by Chon, Seung-Hyun
- [데일리팜=천승현 기자] 국내 개발 의약품이 외래 처방시장 상위권에서 맹활약을 이어갔다. 한미약품의 복합신약 로수젯과 HK이노엔의 케이캡이 3분기만에 처방액 1000억원을 훌쩍 넘어섰다. 대웅바이오의 뇌기능개선제 글리아타민도 선전했다.19일 의약품 조사기관 유비스트에 따르면 비아트리스의 고지혈증치료제 리피토가 올해 3분기 누계 가장 많은 1468억원의 외래 처방금액을 기록했다. 작년 같은 기간보다 2.6% 감소했지만 선두 자리를 견고하게 지켰다. 리피토는 지난 1999년 국내 발매됐다. 국내 출시된 지 20년이 넘었고 100여개 제네릭과 다양한 조합의 복합제가 집중적으로리피토를 견제하고 있지만 여전히 처방 의약품 시장에서 강력한 영향력을 나타냈다. 특허만료 이후 제네릭의 집중 견제에도 처방 의약품 시장에서 강력한 영향력을 과시했다. 다만 최근 성장세는 주춤한 모습이다. 리피토는 지난 2018년부터 지난해까지 5년 연속 외래 처방금액 선두를 기록했다. 국내기업 한미약품과 HK이노엔이 자체 개발한 로수젯과 케이캡이 3분기만에 1000억원 이상을 올리며 선두권에서 고공행진을 이어갔다.로수젯은 지난 9월까지 누적 처방액이 전년보다 19.5% 증가한 1309억원을 기록하며 전체 2위에 이름을 올렸다. 2015년 말 출시된 로수젯은 로수바스타틴과 에제티미브 2개 성분으로 구성된 고지혈증 복합제다.로수젯은 시장 선점 효과와 스타틴·에제티미브 복합제 인기몰이로 가파른 성장세를 거듭하고 있다. 스타틴·에제티미브 복합제는 저밀도 지단백 콜레스테롤(LDL-C)을 낮추는 데 탁월한 효과를 보이는 데다 2개의 약을 따로 복용하는 것보다 약값 부담이 크지 않다는 이유로 선호도가 높아지는 추세다.로수젯은 지난 2020년 처음으로 처방액 1000억원을 넘어섰고 4년 연속 1000억원 돌파를 가볍게 확정지었다.로수젯의 분기별 처방액을 보면 2018년 3분기 처방액 112억원에서 올해 3분기 455억원으로 5년 새 4배 가량 뛰었다. 로수젯은 발매 이후 매 분기 신기록을 경신하며 꾸준한 상승세를 지속했다. 지난 2019년 3분기 처방액 200억원 넘어섰고 2021년 3분기와 지난해 4분기에 각각 300억원과 400억원을 돌파했다. 로수젯의 3분기 처방액 455억원은 선두 리피토와의 격차가 27억원에 불과했다. 케이캡은 3분기 누계 처방실적이 1141억원으로 전년보다 18.7% 성장했다. 케이캡의 지난 3분기 처방액은 400억원으로 전년동기대비 20.6% 뛰었다. 2020년 3분기 213억원에서 3년동안 88.1% 상승하며 성장세가 꺾이지 않고 있다. 지난 2018년 국내개발 신약 30호로 허가받은 케이캡은 '칼륨 경쟁적 위산분비억제제(P-CAB)’ 계열의 항궤양제다. 위벽 세포에서 산분비 최종 단계에 위치하는 양성자펌프와 칼륨이온을 경쟁적으로 결합시켜 위산 분비를 저해하는 작용기전을 나타낸다.케이캡은 기존 프로톤펌프억제제(PPI) 계열 제품보다 약효가 빠르게 나타나고, 식사 전후 상관 없이 복용이 가능한 점 등 장점을 앞세워 높은 성장세를 지속하고 있다. 케이캡은 출시 3년째인 2021년 처방액 1000억원을 돌파했고 지난해까지 2년 연속 1000억원을 넘어섰다. 올해는 일찌감치 처방액 '1000억원 클럽'에 이름을 올렸다.케이캡은 미란성과 비미란성 위식도역류질환에 이어 위궤양, 소화성 궤양·만성 위축성 위염 환자에서 헬리코박터파일로리 제균을 위한 항생제 병용요법, 미란성 위식도역류질환 치료 후 유지요법 등 5개 적응증을 순차적으로 확보했다. 당초 위식도역류질환에 이어 위궤양에 건강보험 급여가 적용됐고 최근 나머지 적응증도 모두 건강보험이 적용되면서 성장세가 더욱 높아진 것으로 분석된다.국내 개발 의약품 중 대웅바이오의 뇌기능개선제 글리아타민이 지난달까지 전년동기보다 23.5% 증가한 1150억원의 처방액을 올리며 전체 3위에 이름을 올렸다. 글리아타민은 효능 논란에 이은 급여축소, 환수협상 명령 등 고비를 겪고 있는데도 처방 시장에서는 오히려 영향력을 확대했다. 콜린알포세레이트 성분의 종근당글리아틴도 3월 누계 처방액이 전년보다 12.2% 증가한 827원으로 고공행진을 이어갔다.한국오가논의 고지혈증복합제 아토젯은 3분기 누계 처방액이 749억원으로 11.9% 증가하며 상위권에 포진했다. 아토젯은 아토르바스타틴과 에제티미브를 결합한 복합제다. 2021년부터 국내기업 100여곳이 아토르바스타틴·에제티미브 시장에 동시다발로 진입했지만 아토젯 시장은 더욱 견고한 상승세를 나타냈다. 아토젯은 종근당이 판매하고 있다.
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- 골수섬유증 신약 '옴짜라' 재수 끝에 급여 등재 목전(K/T)
- by Eo, Yun-Ho
- [데일리팜=어윤호 기자] 골수섬유증 신약 '옴짜라'가 보험급여 목록에 등재될 전망이다.취재 결과, 한국GSK와 국민건강보험공단은 최근 골수섬유증치료제 옴짜라(모멜로티닙)에 대한 약가협상을 최종 타결했다. 이에 따라, 큰 이변이 없는 한 다가오는 6월부터 급여 적용이 이뤄질 것으로 판단된다.옴짜라는 지난해 3월 심평원 암질환심의위원회를 통과했지만 약평위 상정을 위한 조율 과정에서, 약가 산정을 위한 대체약제 선정을 두고 GSK와 심평원 간 이견이 발생해 등재 절차가 중단된 바 있다.이후 GSK는 지난해 자료를 보완, 올해 첫 건강보험심사평가원 약제급여평가위원회를 통과하고 지난 2월부터 약가협상에 돌입했다.구체적인 등재 적응증은 '빈혈이 있는 성인의 중간위험군 또는 고위험군의 골수섬유증 치료'이다.옴짜라는 JAK1, JAK2 뿐만 아니라 ACVR1(액티빈 A 수용체 1형)까지 차단하는 3중 기전을 갖고 있다. 골수섬유증 치료에서 JAK1, JAK2의 억제는 환자의 전신 증상 개선과 비장 비대 감소에 기여할 수 있으며, ACVR1 억제는 헵시딘 발현 감소를 유도해 빈혈 완화에 도움을 줄 수 있다.빈혈 관리는 기존 골수섬유증 환자의 치료에 있어 미충족 수요 중 하나로 수혈 의존성을 높이는 빈혈은 흔히 생각하는 어지럼증 이상의 문제로, 정도에 따라 생명을 위협할 수 있는 심각한 상태로 이어질 수 있다.옴짜라는 임상3상 SIMPLIFY-1 연구와 MOMENTUM 연구를 통해 JAK억제제 치료 이력과 관계없이 빈혈 동반 골수섬유증 환자 치료에서 비장 비대 등 주요 증상 개선과 수혈 의존도를 유의하게 낮추는 것을 확인했다.이전에 JAK 억제제 투여 경험이 없는 골수섬유증 환자의 1차 치료 환경에서 자카비(룩소리티닙) 대비 옴짜라의 임상적 유효성과 안전성을 확인한 SIMPLIFY-1 연구에서 옴짜라는 1차 목표점인 치료 24주차 비장 용적 반응에서 룩소리티닙 대비 비열등성을 확인했다.각 환자군의 수혈 비의존성 비율은 옴짜라군이 66.5%, 룩소리티닙군 49.3%로 집계, 옴짜라군의 수혈 의존성이 유의미하게 낮았다.안서연 화순전남대병원 혈액내과 교수는 "기존 골수섬유증 약물 치료에 사용되던 JAK 억제제는 비장 비대 및 전신 증상 완화 효과를 보이는 반면, 빈혈을 악화시키거나 수혈 의존성을 높이는 등 미충족 수요가 있었다. 옴짜라는 골수섬유증 환자의 예후와 밀접한 빈혈 관리에 있어 유의미한 임상적 가치를 확인한 만큼 국내 출시를 계기로 더 많은 환자의 치료 성적과 삶의 질 향상에 기여할 것"이라고 말했다.
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- 국산 CAR-T 림카토 급여 속도전…낙관론 속 변수는(K)
- by Hwang, byoung woo
- [데일리팜=황병우 기자]국내 개발 첫 CAR-T 치료제 '림카토(안발캅타젠오토류셀)'가 허가 문턱을 넘으면서 시장의 시선이 급여 등재 시점으로 옮겨가고 있다.큐로셀은 허가-평가-협상 병행 시범사업을 통해 림카토의 빠른 시장 진입을 기대 중이다. 일반적인 신약 급여 절차보다 시간을 줄일 수 있는 트랙에 올라선 만큼, 이르면 하반기 상용화 가능성도 거론된다.다만 급여 등재가 단순한 시간표대로 진행될지는 지켜봐야 한다는 시각도 있다. 림카토는 국내 개발 첫 CAR-T라는 상징성을 갖지만, 동시에 수억 원대 비용이 들어가는 초고가 원샷 치료제다.약가 수준뿐 아니라 위험분담, 성과 기반 사후관리, 환급 조건 등이 협상 과정의 변수로 작용할 수 있다는 의미다.결국 림카토의 급여 관전 포인트는 '급여가 되느냐'보다 '어떤 조건으로 얼마나 빨리 등재되느냐'에 맞춰지고 있다.급여 가능성 자체는 비교적 긍정적으로 점쳐지지만, 협상 조건에 따라 실제 상용화 속도는 달라질 수 있다는 분석이다.급여 가능성은 낙관적…병행 트랙으로 속도 기대림카토는 큐로셀이 개발한 자가유래 CD19 표적 CAR-T 치료제다. 허가 적응증은 두 가지 이상의 전신 치료 후 재발성 또는 불응성 미만성 거대 B세포 림프종 및 원발성 종격동 거대 B세포 림프종 성인 환자의 치료다.식품의약품안전처는 지난달 29일 림카토를 품목허가했다. 국내 기업이 개발한 CAR-T 치료제 중 첫 사례다.앞서 식약처는 해당 의약품을 '바이오챌린저' 대상 및 '글로벌 혁신제품 신속심사 지원체계(GIFT)' 제33호로 지정해 개발 초기부터 맞춤형 상담과 신속심사를 지원했다.급여 측면에서도 출발선은 나쁘지 않다. 림카토는 보건복지부의 '허가신청-급여평가-약가협상 병행 시범사업' 대상 약제로 선정된 상태다.기존에는 식약처 허가 120일, 심평원 급여평가 150일, 건보공단 약가협상 60일 등 총 300일 이상이 걸릴 수 있었지만, 병행 시범사업은 이 기간을 줄이는 것을 목표로 한다.회사 역시 급여와 상용화 일정에 대해 낙관적인 분위기다. 약가 협상과 관련해 기존 CAR-T 치료제 약가를 기준으로 동일하거나 소폭 낮은 수준의 조정 가능성을 언급하면서, 약가 자체가 일정 지연 요인으로 작용하지는 않을 것으로 보고 있다.실제로 국내에서 노바티스의 킴리아가 CAR-T 시장을 열면서 급여 선례를 만들었다는 측면에서 충분히 가능한 시나리오다.길리어드사이언스의 지난 1월 예스카타도 '이차 이상의 전신 치료 후 재발성 또는 불응성 미만성 거대 B세포 림프종(DLBCL) 및 원발성 종격동 B세포 림프종(PMBCL)이 있는 성인 환자의 치료' 적응증에 대해 암질환심의위원회(암질심)에서 급여기준이 설정된 바 있다.림카토는 후발 주자이지만, 기존 약제의 평가·협상 경험이 축적된 상태에서 급여 논의에 들어가는 셈이다.다만 업계에서는 급여 가능성과 협상 난이도를 구분해 봐야 한다는 시각도 나온다. 급여권 진입 가능성은 높게 보더라도, 초고가 원샷 치료제 특성상 등재 조건을 둘러싼 논의가 적지 않을 수 있다는 것이다.약가보다 조건 변수…위험분담 논의 주목림카토 급여 과정에서 가장 먼저 주목되는 부분은 약가다. 킴리아가 이미 국내에서 급여권에 진입한 만큼, 림카토 약가 역시 기존 CAR-T 치료제 가격이 중요한 기준점이 될 가능성이 크다.특히 림카토가 낮은 수준의 약가 전략을 택할 경우, 급여 진입 명분은 더 커질 수 있다. 국산 CAR-T라는 정책적 의미에 더해 국내 생산 기반을 갖췄다는 점도 긍정적인 요소로 거론된다.다만 실제 협상에서는 약가 숫자보다 위험분담과 사후관리 조건이 더 큰 쟁점이 될 수 있다는 시선도 존재한다.CAR-T는 1회 투여로 치료 효과를 기대하는 초고가 치료제다. 투여 이후 충분한 반응이 나타나지 않거나 일정 기간 내 재발·사망 등이 발생할 경우, 건강보험 재정 부담과 치료 성과를 어떻게 연결할지가 중요하다.MA(Market Access) 전문가에 따르면 림카토의 급여 가능성 자체는 비교적 높게 점쳐진다. 기존 CAR-T 치료제의 급여 선례가 있고, 회사가 약가를 기존 치료제와 동등하거나 낮은 수준으로 제시할 경우 심평원과 건보공단 입장에서도 등재 필요성을 검토할 여지가 크다는 이유에서다.그러나 제약업계에서는 림카토가 초고가 원샷 치료제 범주에서 논의될 가능성이 큰 만큼 성과 기반 환급, 환자별 추적, 일정 기간 효과 평가, 사후관리 자료 제출 등 조건이 붙을 수 있다고 바라보는 중이다.이는 급여 자체를 어렵게 만드는 요인이라기보다, 협상 기간과 실제 상용화 준비 부담을 좌우하는 변수에 가깝다는 평가다.특히 림카토는 국내 바이오텍이 직접 상업화를 추진하는 첫 국산 CAR-T다. 다국적 제약사와 비교하면 위험분담계약 운영, 담보 설정, 환급 관리, 병원·공단·심평원 대응, 장기 추적 데이터 관리 등에서 조직적 부담이 상대적으로 크게 작용할 수 있다.업계에서는 이 지점을 두고 두 가지 시나리오를 보고 있다.첫 번째는 회사가 약가와 사후관리 조건을 비교적 빠르게 수용하는 경우다. 이 경우 허가-평가-협상 병행 시범사업의 취지를 살려 하반기 급여 등재와 상용화가 가능할 것으로 보인다.림카토가 기존 CAR-T 대비 가격 경쟁력을 확보하고, 사후관리 조건에서도 큰 이견 없이 협상이 진행된다면 시장 진입 속도는 빨라질 수 있다.두 번째는 위험분담 조건을 두고 협상이 길어지는 경우다. 약가 수준은 기존 치료제와 비교해 조율 가능하더라도, 환급 조건이나 장기 추적 기준, 성과 평가 방식 등을 두고 논의가 길어질 수 있다.이 경우 급여 등재 자체가 무산될 가능성보다는 등재 시점과 실제 처방 확대 속도가 늦어지는 형태로 나타날 가능성이 존재한다.초기 관전 포인트는 암질심 상정 시점이다. 허가-평가-협상 병행 트랙에 올라섰더라도 암질심 논의는 거쳐야 한다. 업계에서는 5월 상정 여부를 주목하고 있다.일각에서는 6월 암질심 상정 일정이 없을 것이라는 시각도 있어 상정 시점에 따라 하반기 급여 일정의 윤곽도 보다 구체화될 것으로 보인다.림카토 임상 결과(큐로셀 IR자료 발췌)공급 속도는 강점…국내 제조 기반 차별화급여 이후 상용화 단계에서는 림카토의 공급 경쟁력이 중요한 차별점으로 부각될 전망이다.기존 CAR-T 치료제는 환자 세포를 채취한 뒤 해외 제조소로 보내고, 완제품을 다시 국내로 들여오는 구조였다.이 과정에서 제조, 물류, 통관 절차가 맞물리며 치료까지 일정 시간이 필요했다. 특히 진행 속도가 빠른 말기 혈액암 환자에서는 대기 기간 자체가 치료 접근성의 한계로 지적돼 왔다.반면 큐로셀은 대전의 CAR-T 전용 GMP 생산시설을 기반으로 국내에서 제조·공급하는 체계를 갖췄다. 실제 회사는 림카토가 국내 생산·공급 체계를 통해 대기 기간을 줄일 수 있다는 점을 강점으로 내세우고 있다.큐로셀은 상업화 운영을 위한 통합 솔루션 '큐로링크'도 구축했다. 큐로링크는 병원, 제조소, 물류 간 정보를 실시간으로 연동하는 세포치료제 공급 관리 솔루션이다. 처방부터 백혈구 채집, 세포 제조, 출하, 투여까지 환자 단위 정보를 추적·관리하는 구조다.큐로셀 측도 국내 생산 기반이 환자 접근성 확대에 도움이 될 것으로 보고 있다.큐로셀 관계자는 "림카토가 국내 GMP 시설에서 제조되는 만큼 지방 병원까지도 공급 대응이 가능하다"며 "급여 등재 이후 병원이 처방을 결정하면 회사가 준비한 시스템을 통해 제품 공급 절차를 진행할 수 있다"고 밝혔다.
