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- 2026-05-08 10:08:44
- Policy
- 74% relying on imported substance at risk amid COVID-19
- by Lee, Jeong-Hwan Aug 13, 2020 06:25am
- While the domestic self-sufficiency of pharmaceutical substance has been constantly falling and 74 percent of the industry is relying on overseas-imported substances, experts warn the South Korean pharmaceutical industry may be at risk when the substance supply gets unstable amid COVID-19. They advise the Korean government should set out a plan to promote diversification of overseas substance supplier and domestic manufacturing of essential substances, as well as to tighten safety management of the imported substances. The experts also recommended the government to work on preventive measures as they had to revoke approved licenses on biopharmaceuticals like Kolon Life Science’ Invossa and Medytox’ Meditoxin. On Aug. 10, the National Assembly Research Service published Health and Welfare Committee edition of ‘National Assembly Audit Issue Analysis 2020’ and gave advices to the government. ◆Dependency on imported pharmaceutical substance worsens: Pharmaceutical substances can be categorized either as an ‘active pharmaceutical ingredient (API)’ expressing the drug effect or an ‘intermediates’ essential for making APIs. In last five years, Korea has been manufacturing 31.8 percent, 24.5 percent, 27.6 percent, 35.4 percent and 26.4 percent of pharmaceutical substances in year 2014 through 2018, respectively. Korea’s pharmaceutical substance dependency on imported substances is as high as about 74 percent. As of 2018, Korea has imported 33 percent of substances from China and 9.5 percent from India. The Research Service predicted the pharmaceutical substance supply in Korea would suffer a major setback if COVID-19 pandemic lingers longer and disturbs the supply. In fact, Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) conducted a survey in last February and reported Korean pharmaceutical and bio companies have stocks of pharmaceutical substances lasting two to four months. In particular, the Research Service pointed out carcinogen contamination incidents occurred as the pharmaceutical companies neglected safety management in pharmaceutical substances although it can critically affect quality and safety in finished products. In November 2019, Ministry of Food and Drug Safety (MFDS) has fully investigated valsartan, ranitidine and nizatidine when impurity in synthetic substances was discovered. The National Assembly experts evaluate the pharmaceutical substance suppliers should be diversified and essential substances should be encouraged to be manufactured domestically. And they also advised the Korean pharmaceutical industry to enhance safety measure in imported substances as the industry is heavily dependent on overseas suppliers. The National Assembly Research Service recommended, “Some criticizes it is an excessive action to strengthen the management of substances imported from China and India, because of their low significance and risk. But if the pandemic prolongs or another novel infectious disease breaks out, then the lack of good quality substance supply could delay production of finished products in Korea,” therefore, “The government should induce the industry to diversify overseas suppliers to maintain a good flow of supply and to manufacture essential substances.” The researchers added, “MFDS has disclosed plans to reinforce imported pharmaceutical substance safety control by introducing pre-registration system on overseas substance manufacturer to confirm Good Manufacturing Practice (GMP) compliance and to perform on-site investigation for quality control and management,” and “These pharmaceutical substances need more attention as the industry is relying heavily on India and China for importation of 715 cases (25.6 percent) and 227 cases (9.9 percent), respectively.” ◆Tightening pharmaceutical assessment procedure: The National Assembly Research Service has also urged the government to draw up a plan to prevent incidents like revoking the license on osteoarthritis gene therapy Invossa and botulinum toxin medicine Meditoxin for manufacturing and selling drugs different from the verified item. The investigators not only reprimanded Kolon Life Science and Medytox for their unethical practices, but also criticized MFDS’ verification procedure. Accordingly, MFDS presented their plan to strictly investigate and penalize such data manipulation cases with zero tolerance policy. The researchers, however, pointed out the impact on patients’ safety should not be ignored regardless of MFDS stating the safety in Invossa and Meditoxin should not be a problem. As a solution, the researchers recommended the government to tighten the GMP compliance management and adding more information on precautions when license revocation and recall recurs. The National Assembly Research Service noted, “MFDS aims to conduct a randomized investigation even on drugs with first tier toxicity risk level to prevent data manipulation, and also raise the severity level of penalty on companies financially benefited from an item approved with data manipulation.”
- Policy
- 14 generics for Albendazole, were already approved this year
- by Lee, Tak-Sun Aug 12, 2020 06:00am
- Albendazole is on the rise this year. Albendazole is an anthelmintic ingredient that began to obtain domestic approval in the early 1980s, and only four products were approved from 2017 to 2019. However, as other effects other than the approval of Albendazole became known through social media, new licensed generics have rapidly increased this year. According to the MFDS, the number of Albendazole-based anthelmintic products licensed in 2020 was counted as 14 items (including two for export). There were 64 items approved as Albendazole by the 9th, and most of them were approved before 2010. In particular, from 2017 to 2019, there were only 4 licensed items. There are so many items, and the market size is limited, so the number of new items has not been much since 2010. However, this year, Albendazole has become so popular that there are out of stock, and attracting the attention of pharmaceutical companies. This is due to a phenomenon that occurred when rumors, such as that Albendazole has anticancer effects, spread through SNS such as YouTube. Following anthelmintic 'Fenbendazole' for dogs in last year, 'Albendazole' in this year has become the center of this phenomenon. Moreover, as information that it is effective against the COVID-19 spreads, sales volume is increasing rapidly this year. In particular, Albendazole is an over-the-counter drug, and because it can be easily purchased at pharmacies, more and more people believe in rumors to purchase. As demand exploded, it was difficult to obtain Albendazole at pharmacies for the past six months. Albendazole's popularity has not declined, even though the MFDS and the Medical Association warned in January that its use for purposes other than treating parasitic infections was very inappropriate. The MFDS said, "Albendazole is a drug that is approved for short-term use for anthelmintic purposes. It is not safe for the human body when taken for a long period of time. There is a risk of fatal side effects or seriously impairing the effectiveness of the existing treatment. Patients undergoing treatment for severe diseases such as cancer or chronic diseases such as diabetes are at risk of causing fatal side effects or seriously impairing the effectiveness of the existing treatment.” However, it is analyzed that the existing Albendazole supply shortage continues, and new product approvals are being followed.
- Policy
- Genexine, conducts clinical trials of 'GX-I7'
- by Lee, Tak-Sun Aug 12, 2020 05:59am
- #Interleukin-7 anticancer drug candidate, being developed by Genexine, will conduct a clinical trial in Korea in patients with COVID-19. The MFDS announced on the 7th that it has approved a phase I clinical trial plan for 'GX-I7', a domestically developed COVID-19 treatment. As a result, there have been a total of 15 clinical trials (13 treatments, 2 vaccines) of treatments and vaccines currently in progress in Korea related to COVID-19. 'GX-I7', which was approved this time, is a 'gene recombined human interleukin-7' drug that is being developed as a new anticancer drug by 'Genexine' and was developed through drug Repositioning. The product will be evaluated for safety in a clinical trial in healthy people at the time of development of the anticancer drug, and in this clinical trial, the safety and preliminary efficacy will be evaluated in patients with mild COVID-19 infection. GX-I7 increases autoimmunity by proliferating immune cells (T cells) of COVID-19 infected patients, preventing serious progression or helping recovery. 'Interleukin-7' developed by company R in the United States is undergoing clinical trials in patients. An official from the MFDS said, "As there is great public interest in the development of COVID-19 treatments and vaccines, we will continue to promptly deliver information on the status of clinical trials of domestically developed products. We plan to support as much as possible so that it can be developed quickly.”
- Policy
- Administrative court rules against Lilly on Forsteo pricing
- by Lee, Tak-Sun Aug 11, 2020 06:03am
- The administrative court rejected Lilly Korea’s litigation against the government-authorized drug pricing reduction ordered due to the reimbursement listing of biosimilar. Lilly argued Daewon Pharmaceutical’s biosimilar Terosa cannot be considered equivalent to its original drug, the court rejected the argument. Accordingly, the upper limit pricing of Lilly’s original Forsteo would be lowered by 30 percent. Terosa and Forsteo are indicated to treat patients with osteoporosis. A pharmaceutical industry source reported on Aug. 10 that the Seoul Administrative Court ruled in favor of Korea’s Ministry of Health and Welfare (MOHW) on July 30 for the litigation filed by the company to revoke the ministry’s order to lower the upper limit pricing. MOHW has initially pre-announced its plan to bring down Forsteo’s (teriparatide) upper limit pricing from 326,358 won to 228,451 won as of last March. The pricing reduction was decided as a biosimilar version of the original was listed for healthcare reimbursement. In October last year, Forsteo’s biosimilar version by Daewon Pharmaceutical Terosa passed the government’s review and received the reimbursement in February. Opposing against the decision, Lilly requested a reevaluation but the company took the case to the court when Health Insurance Review and Assessment Service (HIRA) dismissed the request. The pricing reduction order has been postponed until Aug. 24 as the court accepted the request to halt the administrative action before the case concludes. At the court, Lilly consistently claimed the government’s action to lower Forsteo was unjust as the original is different from Terosa. Specifically, the company pointed out the two drugs hardly share the same substance and structure as they have different host and vector. However, the court ruled against Lilly’s claim by referring to the equivalence test conducted with the reference drug based on Ministry of Food and Drug’s (MFDS) standard. The court also elaborated it would be reasonable to evaluate the two drugs demonstrate equivalent effect and benefit from equivalent pharmacological mechanism with equivalent active pharmaceutical ingredient. In last May, Daewon Pharmaceutical released Terosa to the market. IQVIA data found Forsteo is a blockbuster drug that has generated 21.7 billion won last year. When the pricing reduction is enforced, the sales revenue would unavoidably drop as much as the decrease in pricing. And with Terosa entering the competition, Forsteo may lose its upper hand in the market.
- Policy
- GC Pharma begins clinical trial for new type of Fenofibrate
- by Lee, Tak-Sun Aug 11, 2020 06:03am
- In the triglyceride treatment market, GC Pharma, which is running on top of the Fenofibrate 'Lipidil supra', has begun clinical trials for a new formulation of the same ingredient. It seems to be an attempt to improve the shortcomings of Lipidil supra, which should be taken after meals. The MFDS approved a phase I clinical trial protocol to evaluate the safety and pharmacokinetics of GC7009 in healthy adult volunteers submitted by GC Pharma on the 3rd. GC Pharma used Abbott's Tricor 145mg as a reference drug in this clinical trial. Tricor 145mg is a new formulation of Fenofibrate that was approved in 2004, and unlike conventional formulations, it is absorbed quickly in the gastrointestinal tract, so it can be taken regardless of meal. However, existing Fenofibrates such as Lipidil supra are mainly 160mg, and must be administered orally immediately after meals to promote absorption. In order to improve these disadvantages, Hanmi and Daewon have released improved new drugs that can be taken regardless of meals. The drugs are Hanmi's Fenocid ( Fenofibric acid) and Daewon's 'TG Fenon' (Fenofibrate choline). Looking at the amount of outpatient Rx for the first half of 2020, based on UBIST, Lipidil supra recorded ₩7.7 billion, Fenocid ₩4.8 billion, and TG Fenon ₩4.9 billion. In particular, Fenocid and TG Fenon continued to grow after their launch in 2013 and 2017, respectively, putting pressure on the No. 1 item, Lipidil supra. Lipidil supra is a drug introduced from Abbott. GC Pharma is continuing its relationship with Abbott by selling Abbott's licensed Simvastatin-Fenofibrate combination 'Cholib'. Cholib’s Fenofibrate 145mg can be taken regardless of meals. Previously, Abbott had been approved for 'Trilipix' of Fenofibrate choline that can be taken regardless of meals in Korea, but it was withdrawn due to termination of the expiration date in January 2018. Daewon’s TG Fenon is a product that has been improved from Trilipix capsules into tablets. GC Pharma submitted a plan to conduct this clinical trial in 40 healthy adults from this December to next December. If GC Pharma has Fenofibrate tablets that can be taken regardless of meals, it is expected that it will be able to dominate the competition between Hanmi and Daewon and continue its market position established as Lipidil supra.
- Policy
- The HIRA deliberated on benefits for Rinvoq & Kisqali
- by Kim, Jung-Ju Aug 11, 2020 06:02am
- The HIRA (Director Sun-min Kim) deliberated on the adequacy of benefits for these two new drugs at the Pharmaceutical Benefits Advisory Committee held on the 6th and concluded that AbbVie Korea's new drug for rheumatoid arthritis 'Rinvoq ER 15mg (Upadacitinib)' was to be eligible for reimbursement, and Novartis’ advanced or metastatic breast cancer drug 'Kisqali 200mg (Ribociclib)' gives reimbursed benefit if the evaluation amount is received or less. Rinvoq ER 15mg is a drug used for the treatment of moderate to severe active rheumatoid arthritis in adults who do not respond adequately to one or more antirheumatic drugs (DMARDs) or tolerate it. It is a drug that is administered orally at 15mg once a day regardless of meals, and its ease of use is improved compared to the TNF alpha-blocking injection, which is often used in patients with rheumatoid arthritis. The drug has proven effective in patients with rheumatoid arthritis in 5 cases of phase III clinical trials. In addition, it showed a better response rate compared to control drugs such as MTX monotherapy or placebo group. Kisqali 200mg was approved in Korea on October 30 last year as a combination therapy ▲with aromatase inhibitors as the first endocrine therapy in pre-menopausal, postmenopausal, or postmenopausal women, ▲ with Fulvestrant when the disease progresses after the first endocrine therapy or endocrine therapy in postmenopausal women in advanced or metastatic breast cancer patients with hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative. According to this result, Rinvoq ER 15mg will immediately enter into a drug price negotiation with the HIRA in accordance with the order for drug price negotiations from the MOHW. They may step on or remain non-reimbursed or challenge themselves to be reimbursed again.
- Policy
- Ongentys and Rekovelle soon to receive healthcare benefit
- by Kim, Jung-Ju Aug 11, 2020 06:02am
- The South Korean health authority is readying for healthcare reimbursement listing on SK Chemical’s new Parkinson’s disease treatment Ongentys (opicapone) capsule and Ferring Korea’s assisted reproduction techniques (ART) add-on Rekovelle (follitropin delta) prefilled pen as they have reached an agreement on their negotiations. During reimbursement review by the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC), the both companies have decided to accept the weighted average pricing. Reportedly, the rest of the procedure was to negotiate and sign side agreements regarding projected claim amount with National Health Insurance Service (NHIS). NHIS has recently announced the reimbursement negotiations on Ongentys capsule and Rekovelle prefilled pen have reached a settlement. First, Ongentys capsule is a catechol-O-methyltransferase (COMT) inhibitor, which increases density of levodopa in blood plasma and enhances the drug effect. Levodopa is a medicine that supplements a neurotransmitter dopamine the Parkinson’s disease patients lack. SK Chemical has exclusively licensed the sales rights over Ongentys, developed by the biggest Portuguese-based pharmaceutical company BIAL, for the Korean market in March 2018. Ongentys is used as an add-on treatment for Parkinson’s disease patients experiencing motor fluctuation, but their symptoms not improving from levodopa/ dopa-decarboxylase inhibitor (DDCI) therapy. On Nov. 26 last year, the Ministry of Food and Drug Safety (MFDS) approved the drug for the Korean market. Rekovelle prefilled pen is indicated for use in controlled ovarian stimulation (COS) inducing the development of multiple follicles in women undergoing ART, such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI). Unlike other existing options, the drug uses a human recombinant follicle stimulating hormone and provides individualized dosing. Passed by MFDS on Dec. 27 last year, Rekovelle would be soon listed for healthcare reimbursement after completing the eight-month-long negotiation. By overcoming the biggest hurdle of NHIS negotiation, Ongentys and Rekovelle would likely to receive the healthcare reimbursement from next month at latest after MOHW Health Insurance Policy Deliberation Committee (HIPDC) gives them a nod.
- Policy
- Benefits for combination therapy with DM can be expanded
- by Lee, Tak-Sun Aug 10, 2020 06:01am
- Combination therapy between diabetes treatment drugs that are not currently approved for efficacy and effectiveness can also receive benefits. As the MFDS simplifies the method of describing the efficacy and effect of type II DM combination therapy, the insurance authorities can apply benefits to the existing off-label combination therapy (uses other than permitted). The MFDS announced on the 7th that it would simplify the description of the combination therapy among the efficacy and effect items of the license for type II DM treatment. First of all, it is applied from new items, and it will be processed according to the improvement plan if a change permit is applied for existing items. The MFDS announced that this improvement plan has been promoted to harmonize with permits in the United States and Europe, and to reflect the demands of the medical and industrial sectors. In particular, the medical community has argued that benefits for combination therapy should be applied in addition to the license requirements. Until now, the application of benefits has been based on the efficacy and effectiveness of the permits approved by the MFDS. The Korean Diabetes Association recently submitted an opinion to the HIRA that the combination therapy between SGLT-2 inhibitors and TZD (thiazolidinone)-based drugs should also be reimbursed. Currently, the approval of the SGLT-2 inhibitor by the MFDS lists combination therapy by ingredient in efficacy and effect. For example, SGLT-2 inhibitor Forxiga and Suglat are described in the efficacy and effectiveness of the combination therapy with the TZD-based 'Pioglitazone'. It is based on evidence of efficacy in clinical trials. The Diabetes Association further argues that it is expanding the benefits by category rather than by ingredient. In the TZD family, not only Pioglitazone but also Lobeglitazone, and SGLT-2 inhibitors are also available. In this proposal to improve the method of describing the efficacy and effect of the combination therapy by the MFDS, the parts listed by the existing ingredients were grouped together and abstracted into 'other hypoglycemic agents'. However, if only one of the combination therapies submitted clinical trial results, the ingredients were specified and indicated. As a result, it became an opportunity for the insurance authorities to apply benefits for each group rather than for each ingredient based on the approval of the MFDS. An official from the MFDS also explained that the measure reflected the demands of the medical community to expand joint benefits among affiliates. However, in order for the actual insurance benefits to expand, other evidence to prove the efficacy other than corporate clinical trials is expected to be needed. Based on this, it is expected that physician's prescription will be flexible and the treatment means will be expanded if there is actually an increase in the combined benefits between the departments. Pharmaceutical companies can also benefit from sales growth from prescription expansion.
- Policy
- Pricing reduction-evading drug relisting to be rejected
- by Kim, Jung-Ju Aug 10, 2020 06:00am
- Now a new regulation would stop companies from attempting to technically relist a drug to avoid pricing reduction. Following the administrative procedure, the newly revised regulation would be enforced from September at earliest. The Regulatory Reform Committee categorized the Ministry of Health and Welfare (MOHW)-revised ‘Regulation on National Health Insurance Healthcare Reimbursement Standard’ as ‘non-critical’ issue and passed it immediately. According to the Regulatory Reform Committee on Aug. 3, the revision that passed the latest preliminary review aims to stipulate rejection of a drug seeking for reimbursement listing again to avoid pricing reduction. The amendment is considered as a base work for the government’s drug pricing system reform. The ministry’s drafted revision includes four following changes; setting detailed reimbursement decision principle and prioritization listing system supplementing the existing healthcare reimbursement review principle; passing a regulation to reject reimbursement listing application for drug attempting to evade pricing reduction; unifying drug listing review procedure; and establishing and revising procedure of government authorization. The Regulatory Reform Committee reviewed the revised regulation to deny a drug from applying for relisting to avoid pricing reduction. The reviewed regulation stipulates the government to reject a pharmaceutical company’s application to list a drug that has received pricing reduction order, but attempts to maintain the existing sales level. Such case in loophole has prevalently occurred in drug pricing reduction order authorized by the government for providing illegal rebate. The Regulatory Reform Committee categorized the revision as a ‘non-critical’ issue and breezed through the review and clearance. Passing the most important threshold, the revision would come in effect from September at earliest.
- Policy
- Pre-approval of benefits for Spinraza were approved
- by Lee, Hye-Kyung Aug 10, 2020 06:00am
- 5 out of 6 cases for pre-approval of benefits for Spinal Muscular Atrophy (SMA) treatment 'Spinraza (Nusinersen)' last month were approved. After approval of Spinraza benefits, a monitoring report must be submitted every four months before administration of maintenance doses, and all 24 cases of administration monitoring have been approved. In the case of Soliris (Eculizumab), which was the subject of pre-approval prior to Spinraza, 3 new applications for pre-approval for paroxysmal nocturnal hemoglobinuria (PNH) and 40 monitoring were all approved. However, only one out of two applications for reconsideration was approved. Kim Sun-min, President of the HIRA released the results of the 5 items deliberated by a medical treatment review committee in June. Spinraza is an ultraexpensive new drug with ₩92.3 million per 5ml bottle, and medical institutions that want to administer it must apply for prior approval. Spinraza’s Benefits are recognized when 5q spinal muscular dystrophy patients are genetically diagnosed with 5q SMN-1 gene defects or mutations, SMA-related clinical symptoms and signs are expressed under the age of 3, and permanent ventilators are not used. However, in the case of disapproval, it was rejected at the age of 3 years (36 months) or younger, without clearly identifying symptoms and signs related to spinal muscular dystrophy and not being objectively proven. Twenty-four cases applied for monitoring reports were recognized as targets of medical care benefit because the maintenance of motor function was confirmed compared to the time of the previous evaluation as a result of the submitted motor function evaluation. Clinical evaluation (development stage, motor function, respiratory function, etc.) is conducted before the initial administration, 5 times after administration of the introductory dose (4 times), and before each administration thereafter to evaluate the maintenance of administration. In the case of approval as a target for medical care benefits, Medical institutions that have applied for pre-approval of Spinraza and Soliris must administer them within 60 days from the date of notification of the deliberation result, and reapply if it is intended to be administered after 60 days. Details of the deliberation by the medical treatment review committee can be inquired on the website of the HIRA (www.hira.or.kr) and on the medical institution business portal (biz.hira.or.kr).
