- LOGIN
- MemberShip
- 2026-04-15 22:52:05
- Company
- AbbVie expands autoimmune disease drug line-up fast
- by Eo, Yun-Ho Dec 15, 2020 06:04am
- AbbVie is quickly lining up next cash cows after Humira. Especially, the company’s speed of new drug reimbursement listing for the South Korean market has impressed the industry. The multinational company only took about six months and five months for an interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab) and a Janus kinase (JAK) inhibitor Rinvoq (upadacitinib), respectively, from the approval by the Ministry of Food and Drug Safety (MFDS) to reimbursement listing. Skyrizi and Rinvoq were green lit late last year and June, and listed in June and November, respectively. As two drugs are third to fourth drugs to be approved in their respective classes, AbbVie fully utilized the approval-listing linkage system, and accepted the weighted average pricing of other alternative options to expedite the listing process. Also when the company launched the hepatitis type C treatments Mavyret (glecaprevir-pibrentasvir), AbbVie targeted the listing first and started expanding the market presence fast. Both an IL inhibitor and a JAK inhibitor are the most anticipated treatment option for autoimmune diseases since the release of a tumor necrosis factor (TNF)-α inhibitor. While Humira (adalimumab) is leading the particular market, AbbVie seems to have sped up the listing process to minimize the handicap in follow-on drug. The future competition in the market is expected to intensify regardless of the sluggish growth in existing options with slightly different indications the two drugs have. An industry insider commented, “Surely, the quick judgment call by AbbVie Korea was impressive. With the complication of being a follow-on drug, the company could have taken more time to set the strategy based on the differences in indications, detailed mechanism and clinical protocol.” Meanwhile, Skyrizi is indicated to treat adults with moderate to severe plague psoriasis, who need UVB phototherapy or systematic therapy (including biologic therapy). The UltIMMa-1 and UltIMMa-2 studies, which the approval was based on, found patients using Skyrizi have significantly improved their skin condition at week 16. And most of the patients—82 percent and 81 percent—reached Psoriasis Area and Severity Index (PASI) 90, and many of the patients—56 percent and 60 percent—had completely improved skin after a year (52 weeks). Rinvoq has confirmed its treatment effect in 4,443 patients with severe level of active rheumatoid arthritis through five Phase III SELECT trials (SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE and SELECT-EARLY). The result found using Rinvoq alone or with conventional synthetic DMARD (csCMARD) showed lower disease activity and improved remission rate, compared to using a placebo, methotrexate or Humira.
- Policy
- Will special imports be applied for vaccine introduction?
- by Lee, Tak-Sun Dec 15, 2020 06:04am
- Public opinion is growing as the number of COVID-19 confirmed cases is recording the highest every day, and the FDA also urgently approves Pfizer's mRNA-based COVID-19 vaccine following the first vaccination in the UK. Some criticized Korea for failing to preemptively secure a vaccine unlike other advanced countries. It takes some time to get official approval, so it is analyzed that it may be a special import like the last COVID-19 treatment Remdesivir. On the 14th, the Commissioner of KDCA, Jeong Eun-kyeong, at a briefing on the outbreak of COVID-19 in Korea, said, “We are continuing to introduce vaccines developed overseas. We are in consultation with pharmaceutical companies about the amount of additional supplies other than the already secured for 44 million people.” In addition, "At least two or more are currently reviewing and discussing the contract with the goal of completing the contract by the end of the year. It is expected that the supply will be the fastest since AstraZeneca vaccine is produced in Korea, and other vaccines are still negotiating with regard to delivery timing." The total amount of COVID-19 vaccines that the government said to have secured so far is for 44 million people. The COVAX Facility provided for 14 million people, AstraZeneca, Pfizer, and Modena provided for 10 million people, respectively, and Janssen provided for 4 million people. And, Kovax Facility and AstraZeneca have completed the contract. The government is planning to introduce COVID-19 vaccine with the aim of vaccinating next March as soon as possible. It takes too little time to get official approval in Korea. In the case of the AstraZeneca vaccine, which has been contracted with the government, the MFDS is undergoing an expedited review process, but the phase III clinical trial has not been completed. The MFDS plans to complete the approval within 40 days as soon as possible, but considering the release of the national lot, it must apply for a permit in January at the latest. Currently, it is not known when the clinical trials of the AstraZeneca vaccine will end. That is why the Korean government will find a way to use it before formal approval, which takes time, as the US and UK have urgently approved the vaccine. It means that we have no choice but to use the special import system. Special import is a system in which the head of the MFDS imports drugs that are not approved in Korea through importers in order to cope with a public health crisis situation such as an infectious disease pandemic. In June, COVID-19 treatment, Remdesivir was introduced in Korea through this system. At that time, the KCDC (currently The KDCA) requested special import from the MFDS according to the Clinical Committee for New Infectious Diseases proposal, and the MFDS received special import for Remdesivir after deliberation by the National Essential Medicines Stable Supply Council (Disease Management Subcommittee). Decided. It took only 4 days from the request of the KCDC to the decision. It is also the fastest way to introduce the COVID-19 vaccine in Korea. The MFDS can also relieve the burden of expedited screening if it is first introduced through special import and then a formal permit review is conducted. In the case of Remdesivir, it has been granted a conditional permission for Phase III within about 50 days after the decision of special import. The MFDS official also said, "The way to get emergency approval like the United States or the United Kingdom is to go through the special import procedure," he said. "But there must be a request from the KCDA." However, as the special import has not been officially reviewed, it is expected to refer to the approval of advanced overseas regulatory agencies. For example, the US FDA, European EMA, or WHO approval is likely to be the standard. The first AstraZeneca vaccine, which is likely to be introduced, can be referred to other developed countries or WHO approval, even if FDA approval is late. Vaccines by Pfizer and Moderna have not yet been contracted, and the supply timing is uncertain, so it is expected that it will be difficult to request special imports from Korea even if the UK or the US has approved them.
- Policy
- MOHW “Not to worry vaccine shortage, delay and safety”
- by Lee, Jeong-Hwan Dec 15, 2020 06:03am
- The South Korea’s Ministry of Health and Welfare (MOHW) official says the concerns about the shortage or delay in COVID-19 vaccine distribution or AstraZeneca vaccine’s safety issue would be unnecessary. The official claimed the government has already secured vaccine doses for total 44 million people through COVAX Facility and private partnership, which would mean no problem in nationwide vaccination with additional vaccine dose procurement and pre-order deals with Pfizer and Moderna’s vaccines. The ministry official also said the detailed vaccination schedule would be decided flexibly after the introduction of the vaccines in February through March next year, considering the overseas vaccination update, adverse reaction report and demand by the people. MOHW provided the said explanation for the recent news coverage on delayed vaccine distribution and vaccination, and the safety issues. The ministry also refuted the news articles reporting the government has only signed contract with AstraZeneca for the vaccine, and elaborated the terms of purchase and the supply confirmation letter have legal binding as effective as a purchase contract. The South Korean government has only inked the contract with AstraZeneca, but they also confirmed with other pharmaceutical companies to supply their vaccine to the country, which apparently hold liability as much as an official contract. And the government plans to sufficiently secure vaccine doses for everyone in South Korea by pre-ordering doses for 44 million people through COVAX Facility and private partnership, and then seeking more doses for the rest of the population according to the situation. On the news coverage claiming ‘the vaccine supply falling short’ and ‘Pfizer and Moderna depleted vaccine doses leaving nothing for South Korea,’ MOHW official assured the AstraZeneca vaccine manufactured by a South Korea-based SK Bioscience would be released gradually. The official added the vaccine distribution plan by the pharmaceutical companies with the pre-order deals is still unchanged. Also they commented on the public’s concern about the vaccination initiating only around the second half of next year and said the vaccination in South Korea would begin gradually from February through March and further schedule would be decided flexibly. The government aims to adjust the vaccination timing depending on the COVID-19 cases in the country, vaccination update around the world and the public demand. Regarding the U.S. Food and Drug Administration (FDA) skeptical about AstraZeneca vaccine and related safety issues, the ministry explained no approval by the U.S. FDA does not necessarily mean no approval in South Korea. The use of the vaccine in South Korea would be green lit when the Ministry of Food and Drug Safety (MFDS) reviews efficacy and safety and approves of it. MOHW official stated, “MFDS has already started the preliminary review on the vaccine efficacy and safety from October. Safe and effective vaccine would be provided after the thorough review.”
- Company
- Evenity, customized for patients with high risk of fracture
- by Dec 15, 2020 06:03am
- As Amgen's new osteoporosis treatment, Evenity (Romosozumab) was applied from this month, it could be used more by patients. In particular, Evenity, which has proven its strong efficacy in patients with high risk of fracture, may be useful. On the 10th, Amgen held an online meeting to commemorate the launch of Evenity insurance benefits, and announced Evenity's treatment strategy in the ultra-high risk group for osteoporosis fractures. Amgen's new osteoporosis treatment, Evenity (Romosozumab) was approved in May of last year as a treatment for postmenopausal women with osteoporosis at high fracture risk and for increasing bone density in men with osteoporosis at high risk of fracture. Benefits for Evenity have been applied since the 1st. This is when all are satisfied among patients who do not have an effect on or cannot use existing bisphosphonates ▲postmenopausal women over 65 years old ▲Bone density test result measured by dual energy radiation absorption measurement at the central bone T-score -2.5 SD or less ▲Among conditions with two or more osteoporotic fractures. Patients who satisfy this condition can receive benefits once a month, up to one year. Professor Kim Deok-yoon of the Department of Endocrinology at Kyunghee University Hospital announced on this day 'the latest knowledge of osteoporotic fracture treatment and customized treatment strategies for ultra-high-risk patients'. He said, "One in three hip fracture patients cannot walk without help for two years, and one in four dies within 12 months." Kim Deok-yoon, Professor of Endocrinology and Internal Medicine, Kyung Hee University Hospital For this reason, the latest guidelines recommend that patients in these ultra-high risk groups reduce the risk of fracture through strong drug treatment. Evenity can play a useful role as it has the effect of inhibiting bone resorption in addition to existing bone formation promoting agents. If the bone density is the same or improved after 1 year of treatment with Evenity, treatment can be continued with another bone resorption inhibitor. He said, "It is important to lower the risk of fracture with strong drugs such as Evenity from the beginning of treatment for the ultra-high-risk group of osteoporosis fracture. From this month, it is expected that customized treatment for the ultra-high-risk group will be possible with the application of Evenity." He added, "It is the norm to use bone formation promoting agents first in the treatment of patients in ultra-high-risk patients, and then follow-up treatment with bone resorption inhibitors." Amgen believes that Denosumab could serve as a follow-up treatment after Evenity. He agreed that "Romosozumab-Denosumab treatment will be the best combination. In fact, this combination should be used to quickly get out of the risk of fracture." However, he was disappointed by the limited benefit standards. He said that Evenity was considered a very useful drug for patients with super-risk patients, and since last May, he thought that even a non-reimbursed drug should be used and it would be very welcome that Evenity became a reimbursed drug this time. Sang-yoon Kim, managing director of marketing at Amgen Korea's General Medison Division, said, "We will try to establish Evenity as a standard treatment for people at high risk of fractures. And, we will work on long-term osteoporosis treatment strategies ranging from Evenity, which is effective for strong initial treatment to Prolia, suitable for continuous treatment in Korea. I will actively seek out with the medical staff.”
- Company
- The market for erectile dysfunction drugs is on the rise
- by Chon, Seung-Hyun Dec 15, 2020 06:03am
- The market for erectile dysfunction treatments is recovering. The market size contracted in the aftermath of COVID-19 in the first half, but it rebounded in the third quarter. Generic for Cialis have been largely succeeful. According to IQVIA, a drug research institute on the 10th, the market for erectile dysfunction treatments in the third quarter was ₩28.6 billion, up 1.1% year-on-year. The market for erectile dysfunction drugs declined 4.8% and 0.4%, respectively, compared to the previous year in the first and second quarters, but turned to an upward trend in the third quarter. Quarterly erectile dysfunction treatment market size (Unit: ₩million, Source: IQVIA) The market for erectile dysfunction treatments showed stable growth every year, but turned downward in the first half of this year. The contraction of the erectile dysfunction treatment market in the first half is analyzed as the aftermath of COVID-19. The industry says that the erectile dysfunction treatment market is vulnerable to external factors such as the epidemic of infectious diseases because the severity is lower than that of chronic diseases such as high blood pressure and diabetes and it is not essential. There is still low recognition that erectile dysfunction is a disease that needs to be treated urgently, which means that changes in the external environment can affect the market growth. Compared to the early days of the spread of COVID-19, the market for erectile dysfunction treatments seems to have recovered as well as people's social activities have become similar to the past. Most of the major leading products were sluggish. Hanmi's PalPal recorded total sales of ₩15.7 billion in the third quarter. PalPal is a generic for Viagra. PalPal accounts for 18.9% of the total erectile dysfunction treatment market. However, the sales volume declined 4.6% compared to last year, and the growth slowed. Cialis’ generic, Cendom by Chong Kun Dang, ranked second place with cumulative sales of ₩7.5 billion in the third quarter, but sales decreased by 3.2% from the previous year. Sales of major erectile dysfunction drugs by item (Unit: ₩million, %, Source: IQVIA) The original drugs were even more sluggish. Pfizer's Viagra recorded sales of ₩6.4 billion, down 10.7% from the previous year, and Lilly's Cialis, with cumulative sales of ₩4.6 billion, down 4.6% from the same period last year. The cumulative sales of Hanmi’s Gugu in the third quarter rose 13.3% from the previous year to ₩5.8 billion. Kolmar Korea's Kamalafil (generic for Cialis) recorded a growth rate of 20.7%.
- Opinion
- [Reporter’s View] Notes on seeking for COVID-19 vaccine
- by An, Kyung-Jin Dec 14, 2020 05:59am
- The novel coronavirus disease-19 (COVID-19) is spreading at a concerning rate in South Korea. Although the social distancing level was raised to 2.5 two weeks after the government ordered the social distancing level 2 on Nov. 24, the third wave of pandemic seems to keep rising. The authority is even considering on raising the level up to 3, as the daily count of positive cases exceeded 1,000. Regardless, the hope for the end of COVID-19 is growing. A COVID-19 vaccine co-developed by Pfizer and BioNTech has earned the U.S. Food and Drug Administration (FDA) emergency use authorization on Dec. 11 local time. The authorization was made a day after the Vaccines and Related Biological Products Advisory Committee (VRBPAC) issued a recommendation to FDA, making the U.S. the sixth country to approve of COVID-19 vaccine use following the U.K., Bahrain, Canada, Saudi Arabia and Mexico. The U.S. government reaffirmed its strong determination to accelerate the vaccination speed by moving up the recommended vaccination schedule set by the Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP). The nationwide COVID-19 vaccine distribution in the U.S. has started, and experts predict the vaccination can begin from Dec. 14 local time at the latest. Also the U.S. authority is highly likely to grant emergency use authorization on Moderna’s COVID-19 vaccine by the end of the month. Multiple factors played a part to turn around what seemed like the impossible ‘vaccination before Christmas’ and made it actually possible. Since the confirmation of the pandemic, the U.S. Federal Government has been conducting what is called the Operation Warp Speed. The program is an effort led by several U.S. government bodies to rapidly move the development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostics. A long-time Star Trek fan and a director of the Center for Biologics Evaluation and Research (CBER) at FDA, Peter Marks apparently suggested the particular name in April immediately after the Department of Health and Human Services (HHS) briefing. The chief operating officer for Operation Warp Speed, Gen. Gustave F. Perna is leading the program. Regardless of the speculation around the political intervention, the Trump administration aggressively funded the pharmaceutical companies seeking for COVID-19 vaccine by signing the pre-order contracts with the vaccine makers. When they were short of injection needles and other equipments, the U.S. Department of Defense reportedly flew the needed equipments within 48 hours. The super expedited COVID-19 vaccine commercialization was possible with the U.S. government’s full support backed by the Department of Defense and HHS with long history of developing and distributing vaccine. Fundamentally, the attempt to even accelerate the vaccine development and distribution was made, because the pharmaceutical giants, Pfizer and Moderna valued at KRW 250 trillion and KRW 68 trillion, respectively, were confident with their colossal capital and technology. The pandemic shortened typically a decade-long vaccine development process at unimaginable speed. Pfizer-BioNTech and Moderna’s vaccines are designed around a new technology involving messenger RNA (mRNA), which vastly differs from the conventional vaccine mechanism. A genetic substance of mRNA is injected to a human body to generate antibody and induce immune reaction. The threat of pandemic has opened up a new opportunity for the history of mankind. The regular healthy people have a long journey ahead to receive the COVID-19 vaccination. But the people exhausted from the COVID-19 would be full of hope to finally overcome the infectious virus—a thought of the day we return to the daily life without wearing masks. And hopefully, the South Korean government would also assess the vaccines swiftly but accurately, when COVID-19 vaccine makers apply for an approval.
- Company
- Pfizer's Xeljanz XR (once a day), approved in Korea
- by Dec 14, 2020 05:58am
- Pfizer Korea (CEO Dong-wook Oh) announced on the 10th that it has received approval for Xeljanz XR 11 mg, a rheumatoid arthritis treatment, from the MFDS on the 7th. Xeljanz XR is a sustained-release tablet formulation of the existing Xeljanz 5mg (Tofacitinib). It can be used for the treatment of moderate to severe active rheumatoid arthritis in adults who do not respond adequately to MTX or are not tolerated. Xeljanz, an oral JAK inhibitor, inhibits the JAK signaling pathway (Jak-STAT pathway), which is involved in the production of cytokines that cause inflammation in the body. Following the US in 2012, it was approved in Korea as a treatment for rheumatoid arthritis in 2014. Since then, the indication has been expanded to treatment for ulcerative colitis and psoriatic arthritis. The domestic approval of Xeljanz XR is limited to the treatment of rheumatoid arthritis, and indications for psoriatic arthritis and ulcerative colitis are not applicable. Xeljanz 5mg was taken twice a day when treating rheumatoid arthritis in Korea, but it became possible to take it once a day with Xeljanz XR. Xeljanz XR can be used in combination with MTX or taken alone, which will further increase options for patients and healthcare professionals. Hee-yeon Kim, Managing Director of Pfizer's Inflammation and Immunity Division, said, "We are very pleased that Xeljanz, which has pioneered the domestic JAK inhibitor market as a treatment for rheumatoid arthritis, can provide more diverse treatment options." "We will continue to strive to provide excellent treatment options to patients and to make a meaningful difference in the lives of patients."
- Policy
- The vaccination fee for COVID-19 will be free
- by Kang, Shin-Kook Dec 14, 2020 05:57am
- Sohn Young-rae, Head of the planning teamThe vaccination fee is free in principle, and the elderly and medical staff will be given priority. IT starts from February to March next year as early as possible. The inoculation rate of 60-70% for the nation to become immune is expected to reach the second half of next year. Young-Rae Son, Central Disaster Management Headquarters' planning team (spokesperson of the MOHW) explained the vaccine supply plan on CBS radio’s Kim Hyun-jung's NEWS SHOW on the 9th. Vaccine prices vary by pharmaceutical company. Pfizer vaccine costs ₩43,000 per 2 doses, Modena vaccine costs ₩80,000, AstraZeneca vaccine costs ₩8,700, and Janssen vaccine costs ₩19,000. In response, he said, "the government is considering a plan to provide the vaccine itself for free. The total price of vaccination is the price of the vaccine itself and the cost of inoculation at medical institutions." He said, "Currently, the vaccine priorities that other countries are taking, or the priorities that experts say are roughly the health workers, starting with the elderly, with the highest fatality rate of COVID-19." He made it clear that the government will be responsible for any side effects of the vaccine. He said, "Because COVID-19 vaccination is part of national policy, the government will also compensate for side effects."
- Company
- Bavencio, difficulty in expanding indication
- by Dec 11, 2020 06:16am
- The possibility of approval for a renal cell carcinoma indication for Bavencio(Avelumab), an immunotherapy developed by Merck and Pfizer, is very low. This is because the Central Pharmaceutical Affairs Review Committee of the MFDS has not recognized Bavencio's therapeutic effect. The Central Pharmaceutical Affairs Review Committee held a meeting on October 29th, when Merck and Pfizer applied for Bavencio's indications for renal cell carcinoma, and whether the results of the clinical trials submitted were recognized as the agenda. According to the results of the minutes released on the 9th, none of the six members who attended the meeting did not acknowledge the validity of Bavencio. The committee members were cited on the basis of the existence of alternatives such as ▲not meeting the primary endpoint (OS) ▲alternative treatment and follow-up treatment. One member said, "We believe it is reasonable not to approve the permit because Bavencio's OS results have not been met." He said, "The risk ratio of 0.79, which is the result of an interim analysis of overall survival (OS), is judged to be a clinically insignificant result. This is 'JAVELIN Renal 101' study comparing the combination therapy of Bavencio and VEGF-based targeted anticancer drug Inlyta (Axitinib) with Sutene (Sunitinib) monotherapy, a standard treatment for renal cell cancer patients, to confirm the efficacy and safety. According to the results of an interim analysis released last year, the Bavencio+Inlyta combination treatment group had a progression-free survival (PFS) of 13.8 months, significantly longer than that of the monotherapy group, 7.2 months, but the primary endpoint was 11.6 months each. And 10.7 months, there was no significant difference. The risk of disease progression and death was found to be 39% lower than that of monotherapy. In the mid-term analysis, updated in April of this year, there was no significant difference in OS. Accordingly, another member explained, "Because it did not show superiority compared to the conventional therapy, it was judged that the advantages did not appear when the two drugs were administered in combination." "Data should be presented to show that the addition of a follow-up therapy to an existing therapy improves over the existing therapy." Experts analyzed that the impact of clinical design and follow-up treatment would have had an impact. One member said, "Pembrolizumab (Keytruda) and Nivolumab (Opdivo) have the same design and are approved for their significance in OS, but this drug did not." They said, "This drug is more affected by follow-up treatment than the two drugs, so it is judged that the OS did not come out well." According to the 3rd OS interim analysis, 12% of the combination therapy group and 44% of the control group received follow-up treatment. During the follow-up therapy, more than 40% of the control group received immunotherapy. The combination therapy group was 10%. The company also explained, "It seems that these follow-up treatment factors have affected the OS." Even taking this into account, the committee members were negative about the approval. One member pointed out that "The important thing in determining the success or failure of a study is whether or not the primary endpoint is satisfied, and adverse drug reactions of grade 3 or higher also tend to increase compared to the control group, so it cannot be evaluated as completely harmless." He said, "It is also very important that there are other drugs that have already proved the OS, and I think product approval or conditional approval is impossible." Another member also said, "When considering the follow-up therapy and other alternative therapies, the benefit that patients can receive is not confirmed, so the significance of treatment cannot be recognized." In addition, another member said, "There was a case where the indication was not obtained due to the failure to prove the benefit of OS in the first-line treatment of small cell carcinoma of Keytruda and the first-line treatment of non-small cell carcinoma of Tecentriq. It is reasonable not to allow permission considering the fairness of the screening criteria for anti-cancer drugs." In the end, all six expert committee members concluded that the approval was not valid. An official from the MFDS who attended the meeting also said, "When evaluating the OS, the test group receives 3 drugs including the second treatment, and the control group receives 2 drugs, so if the OS results of the test group and the control group are similar, it doesn't benefit the patient." As all of the Central Pharmaceutical Affairs Review Committee disapproved, it was difficult to obtain Bavencio's indication for renal cell carcinoma in Korea. The Central Pharmaceutical Affairs Review Committee is an expert advisory body, and although the opinion of the Central Pharmaceutical Affairs Review Committee is not a decision of the MFDS, the opinion of the Central Pharmaceutical Affairs Review Committee is rarely reversed. Meanwhile, Bavencio has acquired the indications for the first-line treatment of advanced renal cell carcinoma based on the research in Europe and the United States. It has only indications for Merkel cell cancer in March last year in Korea.
- Opinion
- [Reporter’s View] Real reasons for disqualification?
- by Eo, Yun-Ho Dec 11, 2020 06:15am
- A multinational pharmaceutical company Sanofi Korea has failed to qualify as a certified innovative pharmaceutical company. Fairness aside, the transparency in the process seems questionable. Since its first certification won in 2014, the company lost its certification status after six years. Now, only three multinational companies—AstraZeneca, Janssen and Ostuka Pharmaceutical—are certified as innovative pharmaceutical companies in South Korea. The certification is definitely not permanent; if a certified company is disqualified, then the company’s benefit should be taken away. But the problem here is that there is no known reason behind the disqualification. An innovative pharmaceutical company is evaluated based on investment performance, manufacturing facility status, R&D vision and strategy, collaboration and partnership with local and overseas university and research institute, licensing contract, business ethics and business transparency. Reportedly, Sanofi has passed all the ‘quantitative criteria’ for the evaluation. In other words, the reviewers saw disqualifying factor in ‘qualitative criteria.’ But the details have not been disclosed. To Daily Pharm, the government official answered, “The innovative pharmaceutical company certification takes account of not only quantitative evaluation, but also quantitative evaluation.” However, Sanofi Korea has no clue on why they failed the qualification. Their answer of ‘qualitative evaluation is also used’ is not a justifiable answer. They need to state how the company’s qualitative factor scored lower than the passing score. The rumor has it that ‘the health authority was offended by Sanofi terminating the licensing contract with Hanmi Pharmaceutical,’ or ‘the government is trying to reduce the ratio of certified multinational companies.’ But the government lacking transparency has no rights reprimand the rumors. The innovative pharmaceutical company certification program allows the authority to officially certify and grant benefits to the qualifying companies. Fairness and transparency is essential to the program. At least the disqualified companies should have feedback to consider either prepare for the certification reapply or not. The poor reputation of ‘offending the authority is a surefire disqualification’ cannot be good. If such situation continues to happen, then Sanofi would not be alone in this. The relationship between multinational pharmaceutical companies and South Korea should not be overlooked. The country still does not have sovereignty over new drug. Without a clear guideline on the government’s key program for those companies bringing new drugs, the country and the companies’ headquarters could spark a conflict. Even private companies and universities are enforcing ‘blind interview’ to reinforce transparency in the application process. A head coach keeping a silence to a player asking why they are benched should not complain for being replaced.
