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- 2026-04-13 14:48:09
- Opinion
- [Desk's view] It should also prepare for "With Corona"
- by Chon, Seung-Hyun Oct 25, 2021 05:50am
- The government has announced that it will shift the COVID-19 quarantine system to a "step-by-step daily recovery" (with COVID-19) centered on the management of the number of critically ill patients or deaths. As the proportion of COVID-19 vaccination completion exceeds 70%, a relaxed quarantine system such as lifting restrictions on operating hours for multi-use facilities such as restaurants and cafes is expected to be implemented. The pharmaceutical industry is also gradually moving to prepare for "With Corona." Along with the COVID-19 pandemic, the number of people working at home seems to be reduced and the number of people working at the company is increasing. Some companies terminate the flexible working system implemented to avoid overlapping working hours of executives and employees as much as possible. In fact, the pharmaceutical industry has changed a lot in the COVID-19 situation that has been going on for more than a year and a half. The drug prescription market has changed significantly. Markets such as antibiotics and Jinhae girders have shrunk significantly as the number of flu and cold patients has plummeted due to strengthened personal hygiene management to prevent COVID-19. As the COVID-19 vaccination expanded, the pain reliever "Tylenol" jumped to the top in general drug sales. The market landscape has also changed as companies that have benefited from COVID-19 have emerged one after another. SK Bioscience's performance jumped sharply due to the consignment production of the COVID-19 vaccine. Samsung Biologics' performance has soared due to consignment production of COVID-19 antibody treatments, and it is also preparing to produce a Moder or COVID-19 vaccine. Diagnostic kit companies have exceeded 1 trillion won in sales. Pharmaceutical companies' R&D capabilities were also focused on conquering COVID-19. Many pharmaceutical bio companies have rushed to develop COVID-19 vaccines and treatments. Celltrion, which was focusing on biosimilars, developed its own COVID-19 treatment "Regkirona." On the other hand, in general, domestic companies' R&D performance has been lower in technology exports than before COVID-19. The spread of COVID-19 has reduced direct exchanges with global companies and focused on non-face-to-face promotion, so they have not been able to actively win technology exports. Even if the government gradually eases the quarantine system, it will not return to its daily life before COVID-19 in a short period of time, but pharmaceutical companies should gradually prepare for "With COVID-19." If R&D capabilities are actively appealed at large domestic and international academic conferences in the future, it is expected that technology exports, which have been stagnant, will also become active. The development of COVID-19 treatments and vaccines also requires strategies. It is necessary to reflect on whether the R&D efforts to conquer COVID-19 were simply a trick to boost stock prices. Many people in the pharmaceutical industry were also hurt by COVID-19. However, we hope that the COVID-19 crisis will serve as an opportunity for our pharmaceutical industry to become more mature.
- Policy
- HIRA “Will improve RSA and prior authorization system”
- by Lee, Hye-Kyung Oct 25, 2021 05:50am
- The increasing number of applications filed for reimbursement decisions on the use of ultra-high-priced new drugs, such as ‘Zolgensma’ and ‘Keytruda’ that cost 2.5 billion won and 500 million won per shot, respectively, has upped the National Assembly’s demand for the improvement of the Risk-sharing Agreement system (RSA) and prior authorization system. The Health Insurance Review and Assessment Service, which is in charge of the first step to reimbursement, has expressed its position that it will continue to work to determine a reasonable price for drugs and improve the patients’ accessibility to such drugs. At the written responses provided by HIRA after the NA Health and Welfare Committee’s audit that was conducted on the 15th, HIRA expressed its will to improve the RSA and prior authorization system. In-soon Nam the Democratic Party of Korea inquired on the RSA evaluation system and on the direction for mid-to-long-term policy improvement that the authorities will take to address the issue. HIRA explained that comparing the period 2008-2013 (before implementing the RSA system) to 2014-2020 (after implementing the RSA system), the reimbursement rate of anticancer drugs had risen from 58% to 76%, rare disease drugs from 79% to 86%, making a positive influence in improving the listing rate of pharmaceuticals in general. In other words, the authorities explained that the RSA system had helped improve new drug accessibility and reinforce NHI coverage. Also, in the process of operations, subjects for RSA were expanded in July 2019 to drugs subject to special exemption of calculation as rare and severe incurable disease treatments that exceed 2 years of life expectancy, and even to latecomer drugs in October last year. HIRA assured, “To overcome the uncertainties in the long-term effect of the increasing ultra-high-priced drugs, we will prepare a separate RSA scheme to meet the characteristic of each drug, such as a performance-based RSA system." NA member Yeong Suk Seo of the Democratic Party of Korea proposed improving the prior approval system to minimize the fiscal burden of ultra-high-priced new drugs. Seo pointed to the need to regulate prescriptions to ensure the quality of medicines that are ultra-high-priced, require high-level technology, or have high patient risk by systemizing the prior authorization program. Currently 4 products including Strensiq inj., Immune Tolerance Induction (ITI) therapy, Soliris inj. Ultomiris, inj., have received prior authorization. HIRA said, “We agree with the need to secure justification for the administration and prescription of new drugs. We will review the necessity of prior authorization when listing ultra-high-priced drugs." Also, HIRA added that the need to manage patients by unit, the efficiency of the management method, and the need for prompt prescription of such drugs should be considered for medicines that require high-level technology or have high patient risk. HIRA said, “We will discuss with the government and review the reimbursement standards for prescriptions of such medications and procedures.”
- Opinion
- [Reporter's view] Disclosure of the results of the Committee
- by Eo, Yun-Ho Oct 25, 2021 05:49am
- The results of the Cancer Drugs Benefit Appraisal Committee were released from the 13th. The HIRA has accepted complaints continuously filed in the pharmaceutical industry. Some point out that they are not satisfied yet, but it can be said that it is encouraging in itself because the HIRA expressed its intention to deliver the exact reason for the success at the request of the company. In the pharmaceutical industry, discussions on expanding insurance benefits for new drugs have been focused on the Cancer Drugs Benefit Appraisal Committee along with the COVID-19 incident.The Cancer Drugs Benefit Appraisal Committee, which was discussing the clinical usefulness of drugs, began examining the financial burden last year. Since then, as more and more drugs are pending in the pharmaceutical industry due to the Cancer Drugs Benefit Appraisal Committee, even companies have submitted economic evaluation data to the subcommittee. Of course, there may have been many pharmaceutical companies that were greedy last year, and there may have been many drugs that were not clinically useful. So the industry's argument was focused on transparency. This was not a necessary procedure only for the pharmaceutical industry. This is because knowing which drugs have been judged to be unsuitable for what reason, greedy pharmaceutical companies can be criticized and make efforts to find a compromise. Of course, the disclosure of the details of the discussion is 'not yet', but the transparency of the committee has risen to the first level. Beyond the pharmaceutical industry, the healthcare industry is facing a new era. Patients, or their families, now search for surgical papers and search for new drug information in the clinical trial database clinic at clinicaltrial.gov. If domestic licensed drugs do not receive insurance benefits, complaints will pour out to the relevant ministries, the HIRA and the MOHW. The anger of patients and their families looking at "the medicine that exists but cannot be taken" is indescribable. The urgency that cannot be estimated unless it is a party, the level of knowledge of the people who have risen, and the administrative power resulting from the development of the Internet are amazing. Transparency in the process of listing or expanding insurance benefits for new drugs will gradually increase in the future. Both the government and pharmaceutical companies should now fear social views that include desperation. The disclosure of the results of the Cancer Drugs Benefit Appraisal Committee is welcome for now.
- Company
- Boryung Pharmaceutical acquired Zyprexa's domestic rights
- by Kim, Jin-Gu Oct 25, 2021 05:49am
- Boryung announced on the 21st that it has signed an asset transfer contract with Eli Lilly for the schizophrenia treatment "Zyprexa (Olanzapine)." Through this contract, Boryung will take over all rights from Eli Lilly, including domestic copyrights and permits for Zyprexa. Zyprexa is the world's most prescribed treatment for schizophrenia since its launch in 1996. It is a drug used for schizophrenia and bipolar disorder and controls the imbalance of Dopamine in the brain. According to IQVIA, a pharmaceutical market research firm, Zyprexa generated 14 billion won in sales in Korea last year. It occupies about 50% of the domestic Olanzapine market. Boryung plans to further strengthen its central nervous system (CNS) treatment business through the acquisition of Zyprexa. Boryung has CNS drugs such as Buspar (mental inhibitor), Prozac (central stimulant), and Strattera (behavioral disorder). Boryung's goal is to add Zyprexa to achieve 50 billion won in annual sales in the CNS sector by 2025. The contract was made as part of the Legacy Brands Acquisition (LBA) strategy announced by Boryung in July. LBA refers to the acquisition of original medicines that maintain a certain level of sales and market share even after patent expires. It acquired the domestic rights of the anticancer drug Gemzar (Gemcitabine) from Lilly in May last year. CEO of Boryung Jang Doo-hyun said, "The acquisition of Zyprexa has provided an opportunity for a new leap forward in the CNS treatment business." "In order to continue to acquire products that can contribute to Boryung's growth in the future, we are considering a number of products that are leading the domestic and foreign treatment markets," he said.
- Policy
- Domestic approval for Pfizer's Cibinqo (PO) is imminent
- by Lee, Tak-Sun Oct 22, 2021 05:45am
- It was found that the domestic approval for oral atopic dermatitis treatment developed by Pfizer is imminent. This product is a JAK inhibitor in the same family as Xeljanz, which is used as a treatment for rheumatoid arthritis. As JAK inhibitors have recently obtained permission with atopy treatment indications one after another, it remains to be seen what Dupixent's sales will be like. According to the industry on the 21st, the MFDS recently completed safety and effectiveness screening for Pfizer's Cibinqo 50mg (Abrocitinib), an oral atopic treatment. When the review is completed, The approval is expected to be granted soon. This product was first approved in the UK in August as a moderate to severe atopic dermatitis treatment for adolescents and adults aged 12 or older who are suitable for systemic therapy as a one-time use per day. In September, it was also approved by the Ministry of Health, Labor and Self-care of Japan. Cibinqo is known to regulate (IL)-4, IL-13, IL-31, IL-22 and TSLP, which are known to be involved in atopic dermatitis. In a phase 3 JADE Mono-1 study, 62.7% of patients improved by more than 75% at 12 weeks after administration of Cibinqo, compared with 11.8% of the placebo group. The percentage of patients with more than 90% improvement in symptoms was also 38.6% in the Cibinqo group and 5.3% in the placebo group. JAK inhibitors such as Cibinqo have been approved with atopic dermatitis indications in Korea, and treatment benefits are expected to return to patients. Lilly's Oluminant, which was previously used to treat rheumatoid arthritis, obtained an additional indication for treatment of secondary or severe atopic dermatitis in patients subject to systemic therapy in May. AbbVie's Rinvoq was also approved this month for use in adults suffering from severe atopic dermatitis and patients over the age of 12. Rinvoq has also been used as a treatment for rheumatoid arthritis. Analysts say that if Pfizer JAK inhibitory oral treatments are approved, they may lead the atopic dermatitis treatment market. This is because PO formulations are convenient to use. Sanofi's Dupixent, which was launched in 2018, dominates the atopic dermatitis treatment market. Dupixent is the first targeted biological therapy developed for atopic dermatitis, and is gaining high popularity as soon as it is released in Korea. Last year, it recorded annual sales of 23.6 billion won based on IQVIA.
- Policy
- "Annual unused drug returns record ₩2.7 trillion”
- by Lee, Jeong-Hwan Oct 22, 2021 05:45am
- NA member Jung-sook Suh (Pic provided by NA Press Corp) NA member and pharmacist Jung-sook Suh of the People Power Party urged the Ministry of Health and Welfare and the Ministry of Food and Drug Safety to present a specific solution to resolve the long-standing issue of ‘unused surplus inventory of drugs' in pharmacies. Currently, the burden of the unused surplus drugs is solely borne by the community pharmacists that owns or operates pharmacies, and Suh’s request is that the ministries should operate a consultative group with pharmacists’ associations, pharmaceutical industry, and the distribution industry to come up with a practical and direct solution. On the 21st, Suh criticized that “Medicines are public goods, therefore, the issue of surplus inventory of drugs should be resolved by the government with policies. However, the authorities have been passing on the responsibility to the private sector.” Surplus inventory of unused pharmaceuticals had remained a long-standing issue in the pharmacy community since the separation of prescribing and dispensing drugs. However, no clear solution has been found yet. In particular, a considerable amount of normal drugs are being disposed of without being used, which is increasing the socioeconomic cost and even causing environmental pollution. According to Suh, the total amount of surplus inventory of unused drugs that were returned to wholesalers and manufacturers amounted to ₩13 trillion during the past five years, which roughly translates to an average of ₩2.7 trillion per year. Suh pointed out that returns of opened drugs are a major nuisance in pharmacies, and 100 billion's worth of returns and losses occur every year due to such returns. Suh said that the cause and responsibility for this surplus inventory of unused pharmaceuticals are due to the government’s policy failure. As the government has been transferring the burden and responsibility of surplus inventory of drugs to the private sector, it now needs to establish a system for returning unused drugs and standardize the return process at the government’s level. Suh also pointed out that a private consultative body consisting of members of the MOHW, MFDS, Korean Pharmaceutical Association, Korea Pharmaceutical and Bio-Pharma Manufacturers Association, and Korean Pharmaceutical Distribution Association that had been established in August to seek solutions on the issues of unused inventory drugs and out-of-stock drugs should come up with a solution. Suh emphasized, “Various government agencies, KPA, the pharmaceutical industry, and distributors have recognized the issue of unused inventory drugs and established a consultative group. The group should discuss pending issues in depth including the mushrooming generics, generic substitutions, and small packaging unit supply of drugs. She added, “The responsibility should be shared by relevant associations and not be borne solely by the pharmacies. With a strong will to resolve the issues, the relevant bodies should promptly prepare a practical solution.”
- Company
- Supreme court to finally rule on ‘Galvus’ patent dispute
- by Kim, Jin-Gu Oct 22, 2021 05:45am
- The 4-year long patent dispute over the patent of the anti-diabetic DPP-4 inhibitor ‘Galvus (vildagliptin)’ will finally come to an end at the Supreme Court on the 28th. Industry officials believe that the Supreme Court’s decision may affect and modify the overall patent strategies of generic companies in the coming future. If the Supreme Court rules in favor of Ahn-Gook Pharmaceuticals, this will greatly increase the number of challenges filed on substance patents of original drugs, which have been considered impregnable. ◆Will the first ‘invalidation of substant patent extension’ case be born? According to industry sources on the 20th, the Supreme Court issued a notice that it will rule on the Galvus patent dispute between Ahn-Gook Pharmaceutical and Novartis on the 28th. The issue, in this case, is how much of the "extended duration" of the drug substance patent will be considered invalid. The industry anticipates that the Supreme Court’s decision may affect and modify the overall patent strategies of generic companies that will be made. Until now, there has never been a case in which a generic company has overcome the extended term of a drug substance patent.” If the supreme court rules in favor of the generic company and renders even one day of the extended patent term invalid, this will may trigger a series of challenges on substance patents of original drugs, an area that has been considered impregnable. On the other hand, if the Supreme Court accepts Novartis’ claim and recognizes the entire extended period as is, generic companies are expected to maintain their current patent strategy. ◆Mixed rulings at 1st and 2nd trial… what will the Supreme Court’s ruling be? Patent rights are usually protected for 20 years from the filing date. For pharmaceutical products, the time taken for clinical trials and regulatory approval is added to the term. Depending on the recognized period, patent protection for a drug can last 21 years or even 22 years. The same applied to Novartis when applying for Galvus’s patent in Korea. The company requested the patent term for Galvus to be extended to make up for the time spent on clinical trials and for the regulatory review by the Ministry of Food and Drugs Safety. The Korean Intellectual Property Office accepted the request and extended the term by 2 years, 2 months, and 23 days (1068 days). Pic. of GalvusAhn-Gook Pharmaceutical claimed that ‘187 days’ of the extended term for Galvus’s substance patent was invalid. Hanmi Pharmaceutical later joined in the fight. The court ruled in favor of Ahn-Gook Pharmaceutical in the first trial. The Patent Court of Korea accepted Ahn-Gook’s claim and ruled the 187 days invalid. With the ruling, Ahn-Gook Pharmaceutical received the right to release its generic 187 before the expiry of Galvus’s substance patent. Novartis got a partial win in the second trial. The Intellectual Property Trial and Appeal Board had overturned the first instance judgment and ruled that only 55 of the 187 days are invalid. Despite the reduced period, the ruling still rendered a part of the period invalid. As a result, Ahn-Gook did lose the suit but reaped the rewards. Novartis once again appealed, and the case is now being reviewed by the Supreme Court. Novartis is claiming that not a single day should be rendered invalid. The Supreme Court's ruling is expected to be one of the three – recognizing the ‘187 days invalid’ by accepting the ruling of the first trial; recognizing the ’55 days invalid’ by accepting the ruling of the second trial, or accepting Novartis’ claim and not recognizing any part of the term invalid.
- Policy
- There are expectations & concerns about ordering research
- by Lee, Jeong-Hwan Oct 22, 2021 05:44am
- While the government has ordered a study on preferential treatment for domestic new drugs developed by innovative pharmaceutical companies, domestic pharmaceutical companies with new drug technology are expressing both expectations and concerns at the same time. As the government accepts demands from the pharmaceutical industry and criticism from the National Assembly, many pharmaceutical companies think positively about the possibility of enacting a sub-law on innovative new drugs in the Special Act on the Pharmaceutical Industry within next year. International trade friction is not a problem that can be solved by the MOHW alone, but trade pressure-related ministries such as the Ministry of Commerce, Industry and Energy can also make opinions, and if there is a difference in positions between the MOHW. On the 20th, the domestic pharmaceutical industry is paying keen attention to the direction of promoting the "Study on Pharmaceutical Price Support Policy of Innovative Pharmaceutical Companies in Conformity with the International Trade Order" announced by the KHIDI to Korea Online E-Procurement System on the 19th. Pharmaceutical companies said that in order to enact a subordinate law on the preferential treatment of innovative new drugs without problems, the key is to create a "policy and fast policy" by regularizing cooperation between government ministries and government-pharmaceutical companies. First of all, members of the National Assembly's Health and Welfare Committee criticized the absence of Article 17-2 of the Special Act on the Pharmaceutical Industry in this year's parliamentary audit. Pharmaceutical companies are welcoming the Ministry of Health and Welfare's order for research services through the KHIDI. Analysts say that the government has officially promised to enact subordinate laws that have been empty for more than two years after the law was created due to the order of research services. In particular, pharmaceutical companies are positively evaluating the fact that the research service, which was originally scheduled to be ordered next year, has been drastically advanced by nearly half a year due to the announcement of the results in October this year and May next year. Pharmaceutical companies are raising expectations, saying, "More effective domestic drug price preferential measures could be created," when the study included incentives such as suspension and restriction of drug prices after listing for the first time since the development of innovative drugs. Pharmaceutical companies suggested that domestic pharmaceutical companies' willingness to develop new drugs should be specified in the subordinate laws to enjoy the effect of promoting and encouraging domestic pharmaceutical companies' willingness to develop new drugs. Pharmaceutical experts say that the first listed drug price preferential treatment helps domestic new drugs acquire good drug prices in overseas markets when entering the global market, and that the post incentive gives them an advantage over other competitive drugs in the domestic market. An official from A Pharmaceutical, which owns a new domestic drug, explained, "It is positive that the government took the pharmaceutical industry's appeal and the National Assembly's criticism heavily and ordered research sooner than expected. We can expect the government to introduce a specific domestic drug preferential policy in the second half of next year." An official from Company A said, "The fact that we will conduct drug price preferential research, including incentives to lower drug prices, is also in favor of substantially increasing the effectiveness of drug preferential treatment," adding, "However, the upper limit preferential clause should also be prepared at a level without friction." "Only when the government sets the initial registration price for new domestic drugs can it competitively receive drug prices in overseas countries when exporting," he stressed. Pharmaceutical companies expressed serious concern about the fact that even after the ordered study was successfully completed, it could not be introduced or reflected as an actual policy or could be privately cultured. Even if the MOHW and the promotion agency come up with a drug preferential measure without trade friction in the study, pharmaceutical companies are nervous about the possibility that other government ministries, including the Ministry of Commerce, Industry and Energy, will not be reflected as the final policy. If the research agency and the MOHW, which are working-level government ministries enacting subordinate laws, fail to empathize and communicate with the health industry promotion department, the research was completed, but the drug preferential policy could lead to negative results. "In the actual research service process, the Promotion Agency and the MOHW should have a common goal with close consultation," said an official at drug price management at Pharmaceutical B, which owns new domestic drugs. An official from Company B said, "It is difficult to improve the basic evaluation method that only some innovative pharmaceutical companies can preferentially treat new drugs, and it is not easy to avoid controversy." The official said, "In the end, sophisticated sub-laws are needed in the research process to prevent the MOHW from wanting to provide drug preferential treatment," adding, "Efforts should be made to create a drug preferential law that does not differ in opinion between the pharmaceutical field and the government policy."
- Company
- COVID antibody kits are entering the market of clinics
- by Kim, Jin-Gu Oct 22, 2021 05:44am
- Although the sale of COVID-19 antibody diagnostic kits to pharmacies has been banned, diagnostic kit companies are speeding up into the market, especially in hospitals and clinics. It is explained that the industry's impact from the government's measures is not significant because it has focused on the hospital and clinic markets rather than pharmacies in the first place. Although it is said that there is a limit to accurately confirming the effectiveness of the COVID-19 vaccine, related companies are expecting to expand the market in the future due to the increase in vaccination rates. ◆The impact of banning the sale of pharmacies will be limited to some companies According to the diagnostic kit industry on the 20th, the government's ban on selling antibody diagnostic kits at pharmacies is not expected to have a significant impact on the entire antibody diagnostic kit market. This is because most companies have focused on the hospital and hospital markets, not pharmacies. Industry officials say that only a small number of companies have supplied products to pharmacies. According to the MFDS, 14 products from 11 companies were approved as antibody diagnostic kits as of the end of last month. However, about two of them were distributed to pharmacies. ◆The vaccination rate is close to 70%. The demand for antibody diagnostic kits is increasing On the contrary, some companies are expressing expectations in that demand for on-site is expanding as the vaccination rate increases. As of midnight on the 20th, the complete COVID-19 vaccination rate in Korea reached 66.7%. It is expected to exceed 70% within this month. In particular, it is reported that the demand for the vaccine effect has increased further recently as the effect of the COVID-19 vaccine has dropped sharply within two to six months. It is confirmed that front-line hospitals are using antibody diagnosis kits as non-reimbursed items for confirmation of vaccine effects. ◆Pharmaceutical companies are expressing regret over the government's position of "not being able to confirm the vaccine effect" However, the fact that the government reiterated that "there is a lack of medical evidence for the purpose of confirming the vaccine effect" is a common concern among diagnostic kit companies. The diagnostic kit industry has focused on exploring related markets around the time when the domestic complete vaccination rate exceeded 10%. They expected the market for neutralizing antibody diagnostic kits to confirm vaccine effects to grow explosively. However, in July, the government said, there was a lack of medical evidence for the purpose of confirming the effectiveness of the vaccine. The government reaffirmed its position by banning the sale of pharmacies. ◆It is impossible to determine the vaccine effect by simply producing neutralizing antibodies There are three types of domestic approved diagnostic kits. It is a PCR, antigen, and antibody diagnostic kit. PCR and antigen diagnostic kits are used to confirm suspected COVID-19 patients. Antibody diagnostic kits are used to determine if people have been infected with COVID-19. People who have been infected with COVID-19 develop binding antibodies, which is the principle that antibody diagnosis kits check whether or not binding antibodies are produced. The diagnostic kit industry focused on the fact that it can also check whether neutralizing antibodies are produced with antibody diagnostic kits. Neutralizing antibodies are antibodies that occur after vaccination. They have argued that their own clinical results can determine whether neutralizing antibodies are produced with 90% accuracy. The government is in a position that it is difficult to determine the effectiveness of the vaccine simply by producing neutralizing neutralizing antibodies are produced. This is because in order to check the vaccine effect, it is necessary to determine how much neutralizing antibodies are formed in the body.
- Policy
- Janssen, granted permission to import advanced bio medicines
- by Lee, Tak-Sun Oct 21, 2021 05:14am
- Janssen Korea has obtained the second approval for the import business of advanced bio medicines after Novartis Korea. Janssen is also expected to introduce related products in the near future because advanced bio-medicine items designated by the MFDS can only be approved if it is approved for the advanced bio-medicines import business. On the 18th, the MFDS approved Janssen Korea as an advanced bio-medicine importer. Advanced bio-medicine is a new category of medicines created when the Advanced Regenerative Medicine and Advanced Bio-medicine Safety and Support Act was enacted and enforced in August last year. Cell and gene therapy mainly belong to advanced bio medicines. Existing cell and gene therapy drugs have been approved by the Pharmaceutical Affairs Act, but a separate management system has been established in accordance with the new law. All items approved as new items after the enforcement of the law are Novartis products. Previously, Novartis was the only importer to obtain advanced bio-medicine import license. Novartis has been approved for Kymriah, the No. 1 domestic CHIMERIC anti-gen receptor-T cell (CAR-T), as well as Zolgensma and Luxturna. All of these are expensive and "one-shot" treatments that can be treated with one use. Attention is currently being paid to benefit negotiations in that it is a new concept of medicine and is being sold at high prices. Janssen is also expected to rush to introduce related products in Korea as it has acquired a high-tech biopharmaceutical import business this time. Janssen is in the process of overseas listing of products such as "Cilta-cell," a CAR-T treatment that treats multiple myeloma. The MFDS designated the drug as a rare drug in August last year. It is also developing gene therapy for rare retinal diseases. Luxturna, approved by Novartis, is also a gene therapy that treats rare retinal diseases. As Novartis preoccupies advanced bio-medicine in Korea, Janssen is also preparing for approval. With the gradual introduction of advanced biomedics overseas in Korea, serious discussions on drug prices and follow-up management seem to be needed.
