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- Policy
- 5 years after the drug patent linkage system
- by Lee, Tak-Sun Dec 12, 2019 06:30am
- At the Four Points Hotel Seoul Guro, the 2019 Drug Forum was held under the direction of Jae-Hyun Lee, School of Pharmacy, Sungkyunkwan University (fourth from left)."There are many cases where overseas pharmaceutical companies have succeeded in using the US-licensed patent linkage system. But Korean pharmaceutical companies haven't even tried it. It's time to think about why they are not using the system". More than five years have passed since the introduction of Korean licensed patent linkage system based on the US Hatch Waxman Act with the Korea-US FTA in March 2015. The licensed patent linkage system protects the original drug patents listed in the MFDS and grants generic monopoly rights to companies that have neutralized the patents. Although there was a lot of concern that generic drugs would enter the market in the early stages of implementation, the impact on the market is less than expected. Director General, Myung-jin Chung Myung-jin Chung , head of the Korea Health Industry Development Institute, who conducted an impact assessment during the 2018 year at the Policy Forum held at the Four Points Hotel Seoul Guro, said, “Contrary to concerns over the introduction of the system, domestic pharmaceutical companies sales increased YoY due to the lack of many original companies’ ban on sales and the activation of exclusivity for generic product. The KHID's impact assessment showed that sales of generics increased up to ₩6.5 billion in 2018, and the market entry period was also shortened from 1.3 months to 4.6 months. However, there are a lot of comment that the drug patent linkage system lacks effectiveness. In the policy forum discussions, Sung-min Park, lawyer at HnL Law Office, pointed out that there were no cases of entry into the United States using the drug patent linkage system. “Even if a generic market monopoly is given through exclusivity for generic product, lower profits will be lowered if the market entry rate or market share of the latter is low during that period. In the US, the market share of late-release drugs is high in the monopoly period of 180 days, but in Korea, this is not the case, so we need to discuss how to increase the speed and market share” emphasized the lawyer. Hye-eun Shin, professor of law at Chungbuk National University, made a similar point. Professor Shin said, "There are no successful cases of entry into foreign countries by using the law, we should identify the cause and give direction". The professor added, "We need benchmarking on success cases such as Teva and Ranbak". Yoon-ho Kim, the chairman of the Korea Pharmaceutical Patent Research Society (Hanmi, Patent Team) said, “Maybe the goal was to minimize the impact when it was introduced in Korea. Now, I think that we will be a better system if we become more substantial and develop it as an opportunity for R & D development and globalize it”. In addition, the company is likely to raise the profits of items sold in exclusivity for generic product., and the MFDS, which is a related ministry, is concerned about entering the global market. Hyo-jeong Kim, Director of the Drug Management and Patent Licensing Division, said, "The way to increase the market entry rate and market share of exclusivity for generic product is deeply related to the reliability of generic drugs." "Currently, the MFDS is the most important part, and there is a part to improve awareness Kim said, "I believe that a patent case and product development technology have been accumulated through the introduction of the drug patent linkage system, so a real case study position is necessary for entering the US market." Some also suggested that the market entry period was shorter than the impact assessment results with the drug patent linkage system. Kyung-Joon Lee, head of Boryeong Pharmaceuticals, said, “If we take into consideration the fact that patents are incapacitated due to the challenges of pharmaceutical companies, we will have a much more positive number than the results of impact assessments.” “We are still unable to lag behind our competitors. There are many cases of requesting unconditional judgment without consideration, and I hope that the related laws will be revised in such a way that the positive aspects of the introduction of the drug patent linkage system can be highlighted through the impact assessment”. It was pointed out that if the patent invalidation is confirmed, exclusivity for generic product efforts will be lost. Therefore, even if it is determined to be invalid, it is necessary to improve the system so that it can be used as a right target. However, Hyo-jeong Kim explained, "There are some parts that are difficult to consider as a result of the review so far, but if you get exclusivity for generic product, you can be protected even if the patent is invalid In addition, it also defeats exclusivity for generic product challenge by intentionally deleting the patent list. Kim said, "There is a reasonable part, and we will revise and revise it". Kim said, “We will go through the process of collecting opinions by the end of this year, and we will start the legislative process for improvement plan, and we made some practical improvements and gathered opinions”.
- Policy
- 10 new rare diseases applied with special case from 2020
- by Kim, Jung-Ju Dec 11, 2019 10:20pm
- Special case insurance benefit would be applied on ten new rare diseases including adult-onset Stills disease and Kienbock’s disease from next year. Korean Ministry of Health and Welfare (MOHW) issued a revised notice on Tuesday of ‘Standard on Special Case Insurance Benefit for Individual Copayment’ reflecting the changes. The special case benefit would be applied to patients, diagnosed with one of designated rare diseases, starting from the day of hospital visit or hospitalization the diagnosis is made. The newly designated ten rare diseases are; Cryoglobulinemia vasculitis; choroideremia; Long QT syndrome; hereditary hemorrhagic telangiectasia (HHT); adult-onset Still’s disease; Kienbock’s disease; adult-onset Kienbock’s disease; X-linked ichthyosis; steroid sulfatase deficiency and X-linked ichthyosis; and infant-onset Harlequin syndrome. The changes would come in effect from Jan. 1, 2020. The ministry is to accept public opinion on the notice until Dec. 20, and finalize the changes as it is, if no concerning issue arises.
- Company
- China okays Samsung’s Herceptin biosimilar Phase 3 trial
- by Lee, Seok-Jun Dec 11, 2019 10:20pm
- The Chinese health authority has green lit Samsung Bioepis’ first clinical trial in China. On Dec. 10, Samsung Bioepis announced China’s National Medical Products Administration (NMPA) has approved the company’s Phase 3 investigational new drug protocol on SB3, a biosimilar version of Hercpetin with trastuzumab. The first patient of Samsung Bioepis’ first clinical trial is scheduled to get treated in the first quarter of next year. The Phase 3 trial is planned treat 208 Chinese patients with breast cancer. Samsung Bioepis to initiate its first clinical trial in China (indicated in red) In February, Samsung Bioepis has signed a partnership contract with Chinese private equity firm C-Bridge Capital for clinical trial, government approval and commercialization in China. The recently approve clinical trial would be conducted along with C-Bridge Captial’s biopharmaceutical company, ‘AffaMed Therapeutics.’ Established in 2014, C-Bridge Capital is China’s topline healthcare-dedicated private equity firm. The company’s portfolio covers general healthcare service sectors including biopharmaceutical, medical device and diagnostics, and its current assets under management is approximately two trillion won. Besides SB3, Samsung Bioepis is to collaborate with C-Bridge Capital on conducting clinical trials, processing approval applications and launching SB11 (ranibizumab biosimilar, referencing Lucentis), SB12 (eculizumab biosmilar, referencing Soliris) and SB15 (aflibercept biosimilar, referencing Eylea) in Chinese market. Before inking the partnership with C-Bridge Captial, Samsung Bioepis has also inked another partnership with China-based biopharmaceutical company ‘3S Bio’ in last January to market SB8 (bevacizumab biosimilar, referencing Avastin) and some other pipelines.
- Company
- Hanmi’s diabetes pipeline still standing in the storm
- by Chon, Seung-Hyun Dec 11, 2019 06:47am
- Hanmi Pharmaceutical’s efpeglenatide with the title of the biggest license-out deal to date is going through harsh times before reaching the finish line. The company’s unbent commitment for the pipeline kept it alive, despite amending the license out agreement twice and the partner company shifting R&D pipeline focus. Although it seems to have international clinical trials on their way unaffected, the company is now concerned of change in global commercialization partner. Headquarters of Hanmi Pharmaceutical On Dec. 10, Hanmi Pharmaceutical’s stock price closed at 298,000 won with 6.88 percent drop from the day before. Hanmi Science also took a 4.57-percent fall. Experts see that news of Hanmi Pharmaceutical’s partner company, Sanofi looking for a partner to launch efpeglenatide may have intimidated the investors. ◆Efpeglenatide surviving albeit Sanofi’s R&D pipeline shake-up In fact, efpeglenatide’s development timeline has not been changed. Sanofi broke a news of acquiring a U.S.-based oncology R&D company Synthorx for USD 2.5 billion (approximately three trillion won) on Dec. 9, and elaborated its plan to shift the focus of R&D pipeline and management style. Sanofi official stated it would prioritize investment on oncology, rare disease, blood disorder and neurology, while it would cease researches on diabetes and cardiovascular disease. However, the multinational company’s news also included its plan to complete ongoing Phase 3 clinical trials of efpeglenatide, but not to pursue a efpeglenatide launch. At face value, Sanofi means to not commercialize efpeglenatide, but it also means the pipeline survived another major pivot in Sanofi’s R&D pipeline. The candidate drug is the only diabetes treatment pipeline among five investigational drugs the multinational company plans to submit the U.S. Food and Drug Administration (FDA) New Drug Application (NDA) for in two years time. A Sanofi executive stressed “It was the best decision for the successfully launch of efpeglenatide while maximizing the productivity of our research engine. It was irrelevant to efficacy and safety of the substance, and it would make no changes on license-in agreement with Hanmi Pharmaceutical”. Technically, efpeglenatide proved its potential to Sanofi’s new CEO, Paul Hudson appointed last August, despite his firm commitment to reprioritize R&D pipeline. In the year, Sanofi suddenly stopped research in a trigonal GLP-1/GIPR/GCGR agonist, SAR441255. And the French company also has paid back upfront fee to exit a 300-million-dollar partnership deal over SGLT1/2 dual inhibitor Zynquista (sotagliflozin) signed in 2015. ‘New Drug Application Submission Timeline 2019-2023’ unveiled during 3Q performance presentation by Sanofi ◆Amending license-out agreement twice, two LAPSCOVERY medicines returned Starting with the license-out agreement, efpeglenatide has gone through a series of ups and downs. Efpeglenatide, a GLP-1 injection for type 2 diabetes, is a bio drug candidate that extended once-daily administration interval to once-weekly and even once-monthly. It incorporated Hanmi Pharmaceutical’s key platform technology, ‘LAPSCOVERY’. LAPSCOVERY, or Long Acting Protein/ Peptide Discovery platform technology prolongs the duration of biologics’ short half-life to reduce administration frequency and dose, which would ultimately reduce adverse reaction and improve efficacy. Chemically conjugated biologics and protein ‘LAPS-carrier’ amplifies duration of the substance’ effect in human body and maintains the effect for maximum one month even with a small amount. In November 2015, Hanmi Pharmaceutical signed a license-out agreement with Sanofi on efpeglenatide, which still to this date is the biggest deal in the history of Korean pharmaceutical industry. The 2015 deal transferred technology of a EUR 3.9 billion-worth Quantum Project (efpeglenatide, long-acting insulin, and efpeglenatide with long-acting insulin) to Sanofi. The upfront fee alone was 400 million euro. But after closing the deal, a number of unexpected changes were made. In December of 2016, Hanmi Pharmaceutical amended the agreement to drop one of the drug candidates from the ongoing technology transfer project. Out of three drug candidates, Sanofi decided to return license over the long-acting insulin. Agreement terms on the long-acting insulin combination was also changed so that Sanofi would acquire it after Hanmi Pharmaceutical develops it for a certain period of time. As a result, Hanmi Pharmaceutical paid back 196 million euro out of Sanofi’s 400-million-euro upfront payment. The milestone payments were also affected and the overall deal was shrunk by over one billion euro, down to 2.82 billion euro. Regardless of the reduction, the upfront fee and overall scale of the efpeglenatide deal is still historic record high within the Korean pharmaceutical industry. Hanmi Pharmaceutical-Sanofi agreement revised in June (Source: Financial Supervisory Service) In June, however, Hanmi Pharmaceutical and Sanofi agreed to amend the agreement once again. Hanmi Pharmaceutical lowered the maximum co-research expense from 150 million euro to 100 million euro with about 50 million euro (approximately 65 billion won) cut. The first amendment actually included a clause for Hanmi Pharmaceutical to contribute 25 percent of efpeglenatide R&D expense, which was supposed to be covered entirely by Sanofi. And Hanmi Pharmaceutical set the research expense cap at 150 million euro. In just about two years, Hanmi Pharmaceutical was able to revise the clause added in 2016 to be more favorable to them. When amending the agreement for the second time, Hanmi Pharmaceutical also postponed its payment period of clinical trial expense. Initially, Hanmi Pharmaceutical was supposed to pay when Sanofi quarterly billed for efpeglenatide’s clinical expense. The additional expense of 40 million euro out of 68.5 million euro would be billed on an earlier date between September 2022 and submission date of Biologics License Application (BLA) to FDA. The bill is to be cleared by Hanmi Pharmaceutical within 15 days. The rest of 28.5 million euro would be paid on earlier date, either in September 2023 or the FDA approval date. Basically, Hanmi Pharmaceutical is to pay Sanofi whenever efpeglenatide development achieves a milestone. When Sanofi initiated large scale clinical trials on efpeglenatide, the expense soared more than expected. But then Sanofi seems to have accepted Hanmi Pharmaceutical’s request to lower its contribution in clinical expense. Meanwhile, risk factors in LAPSCOVERY technology have been raised. Janssen signed a technology transfer deal on JNJ-64565111, a candidate diabetic obesity drug, but it had to suspend clinical trial due to production delay. In July, Janssen returned its license on JNJ-64565111 and the license-out agreement covering two candidate drugs based on LAPDISCOVERY technology fell through. Spectrum Pharmaceutical’s in-licensed Rolontis, a neutropenia treatment, is the first LAPSCOVERY-applied medicine to get so close to commercialization. A U.S.-based Spectrum Pharmaceutical filed for FDA approval on Rolontis at the end of last year, but it dropped the BLA in March as the authority ordered for more supplementary data. The application was submitted again in October. ◆ Five out of two efpeglenatide clinical trials completed selecting participants Currently, the efpeglenatide development is going smoothly. Two years after signing the deal, Sanofi officially unveiled a detailed plan on efpeglenatide at the end of year 2017. By the end of 2017, Sanofi initiated the first Phase 3 clinical trial to compare efpeglenatide and placebo, and in April last year, the company initiated a large-scale Phase 3 trial to test efficacy and safety in treating cardiovascular diseases. Another Phase 3 trial was initiated since September last year to compare efpeglenatide and competing product Trulicity (dulaglutide) as a combination therapy with Metformin. In October last year, a protocol on combination therapy with efpeglenatide and basal insulin was registered, and in December same year, the fifth Phase 3 trial was initiated to confirm the drug treating Type 2 diabetic patients who cannot control glucose level either after Metformin single therapy or Metformin and sulfonylureas combination therapy. The overall target number of sample is 6,340. As of now, two out of five Phase 3 trials on efpeglenatide have gathered sufficient number of participants. Most recently, placebo-comparing Phase 3 trial AMPLITUDE-M has gathered targeted number of patients. The investigational drug’s key trial, AMPLITUDE-O testing effect of efpeglenatide on cardiovascular outcomes has registered more than planned number of participants of 4,076 patients in June. A Hanmi Pharmaceutical official stated, “Sanofi has promised to concentrate on completing numerous Phase 3 trials currently ongoing to develop efpeglenatide successfully”. Two Phase 3 efpeglenatide trials have registered enough number of patients (Source: ClinicalTrials.gov)
- Opinion
- [Reporter's view] Illegal Rebate CSO
- by Lee, Jeong-Hwan Dec 11, 2019 06:40am
- I suddenly thought that the trifoliate orange is innocent when I was covering the law revision extending medical and pharmacological expenditure reports to pharmaceutical CSOs. Pharmaceutical industry ethics management (CP) experts refer to CSOs based on drug expertise as tangerines, the CSO which was altered as an illegal rebate, as trifoliate orange Unlike tangerines that boil sweet and sour flesh, the trifoliate orange has a thick peel and a lot of seeds, so it has little flesh and a strong sour taste, making it suitable for comparing illegal CSOs. However, the pharmacological benefits of November’s trifoliate orange in season were excellent compared to the illegal CSO. Donguibogam (Principles and Practice of Eastern Medicine) says that the trifoliate orange is also effective for respiratory diseases and congestion such as relieving severe itching and detoxification of liver, relieving bloating and coughing. Even citric acid removes fat, which promotes nutrient metabolism in the body and helps with diet. Illegal CSOs, on the other hand, are all evil and no good to the health and pharmaceutical industry as well as to the health of normal CSO industries. The Korean version of Sunshine Act, launched from this year, is poised to expand the scope of application to pharmaceutical CSOs following pharmaceutical companies. It will be realized through the revision of the Pharmaceutical Affairs Law and the Medical Device Act, which contains the regulation on drug rebate, but it requires the efforts of the pharmaceutical industry and some altered CSOs. Korea's pharmaceutical industry, the future growth engine, is no longer able to stay in the generic drug structure. Generics that are already on the market and have expired major patents and poured out many of the same ingredients cannot lead the industry in the rapidly changing Fourth Industrial Revolution. It's been a long time since generics have lost their power as a cash cow, supporting the pharmaceutical industry and serving as a source of new drug research and development (R & D). There are numerous precedents that the generic fraudulent competition, which is hard to find market innovation, eventually leads to an illegal rebate war. Even in the case of generic competition, there is no argument against the need for a direction based on drug expertise through legitimate CSOs. The legislature and the Ministry of Health and Welfare soon agreed that they would embark on a complementary legislation that would include CSOs as drug companies in drug suppliers. This means a direct signal to the pharmaceutical industry and the CSO industry to initiate self-cleaning as a means of amending the law. The Welfare Ministry also believes that the revision of the law cannot be the magic bullet to eradicate all drug rebates. In the end, the rebate eradication can only be achieved if the pharmaceutical industry and the CSO themselves show their professionalism in the legal pharmaceutical competition market established by the government and the National Assembly, and then dig out the old and corrupt business. In addition to the yellow and coveted fruits, the trifoliate orange trees have been planted as a substitute for fences since ancient times, because of the stems of roses and oaks that are scary and thorny. Taking into account the medicinal efficacy and physical function of the trifoliate orange, which has been likened as an illegal CSO, we are dreaming of a future where the domestic CSO industry will grow into a strong and robust industry dedicated to pharmaceutical sales for medical and pharmacist experts.
- Company
- MSD’s new labor union in talks for unpaid wage compensation
- by Kim, Jin-Gu Dec 11, 2019 06:39am
- MSD Korea employees have gathered again under a new umbrella. Majority of the members previously affiliated under Korea Democratic Pharmaceutical Union MSD Chapter left and established a new labor union of their own. ‘MSD Korea Laborers’ Union’ is the new name for the independent corporate labor union. On Dec. 5, the union convened its first general meeting and kicked off with a union representative election. MSD Korea’s labor union was formed for the first time as the 17th chapter of the Korea Democratic Pharmaceutical Union last year. Since then the union engaged in a single union talks with the corporate management over compensation of unpaid wages and other agenda. However, discrepancies loomed between the executive body and members during the process. Some members started complaining that the executive body is not properly speaking up for the compensation for weekend wage. As a result, the members started working on forming a new labor union from September last year. Except for the chairperson from the MSD Korea Chapter, most of the executive body left the union and formed a new one. 80 percent of the members also joined the new one. Currently, the new union has about 280 members. With the scale, the new union gained support of the majority and earned the representative bargaining rights. The new union is now in talks with the employer about compensation for weekend wage and reasonable salary raise negotiation. Since October 31, total five talks have been held. The labor union is specifically demanding for an immediate payment of five-year overdue weekend work wage, and affirmed seven percent raise in salary. According to the labor union, MSD Korea has not properly paid employees for the weekend work by calculating it as normal daily expenses. The union estimates the overall unpaid weekend wage is about five billion won. The management is holding on to the four percent salary raise. They have agreed on compensating for the overdue weekend wage, but they want to further discuss about the details of the payment later. As it is a matter of ‘unpaid wage’, the union is asking for a letter to affirm payment of the unpaid wage without further discussion. Apparently, both of parties have agreed to make decisions and resolve the said issues within this year. Shim Sang-nam, elected as a chairperson to lead the first general meeting explained the reason of forming a new labor union saying “The recently addressed issues needed a union with more democratic and ethical qualities. Also multiple problems reported constantly called for a new union urgently and solely for MSD employees”. “MSD Korea Laborers’ Union aims to resolve salary raise negotiation and unpaid payment issues in short term, but it would thrive to create the best working environment with MSD-appropriate levels of salary, benefits and guaranteed retirement age”, the chairperson added.
- Policy
- Kolon wins approval on inhaled schizophrenia treatment
- by Lee, Tak-Sun Dec 11, 2019 06:38am
- An orally inhaled medicine for treating agitation associated with schizophrenia is to be released in Korean market for the first time. The public’s interest is heightened by the news as inhalation powder has higher speed of body absorption and delivers effect in the shortest time. , Korean Ministry of Food and Drug Safety (MFDS) on Dec. 5 granted an approval on Kolon Pharma’s license to market Adasuve (loxapine) inhalation powder (10 mg). Adasuve is used as an acute treatment of mild and severe agitation associated with schizophrenia or bipolar disorder in adults. When inhaled with hand held drug delivery technology system ‘Staccato’, powdered loxapine is rapidly absorbed by the lung and achieve maximum plasma concentration in approximately two minutes. The drug’s administration is limited to single 10 mg dose within 24 hours. The approved label of the drug requires it to be administered only by a healthcare professional with immediate on-site access to equipment and personnel trained to manage acute bronchospasm. Developed by a U.S.-based company Alexza Pharmaceuticals, Adasuve was approved by the U.S. Food and Drug Administration (FDA) as the first orally inhaled treatment for schizophrenia in December 2012. Currently, Teva has the license to market the treatment in the U.S. Loxapine has been used for schizophrenia before Adasuve, as products like Loxapac used to be available in Korea. But now there is no other approved product with the same substance. In clinical trials with over 650 patients with acute agitation, Adasuve confirmed reduction of the condition more statistically significant than placebo. Multiple patients treated with the treatment experienced serious reaction of bronchospasm. Patients with asthma, COPD and other lung disease who inhaled the treatment were often reported with bronhospasm, and they were then treated a short-acting beta-agonist bronchodilator. The most commonly reported adverse reactions were dysgeusia, sedation and throat irritation. MFDS designated the treatment as a subject for Risk Management Plan (RMP) to continue monitor its adverse events after the commercialization.
- Company
- Korean biosimilars carving out Herceptin market share
- by Chon, Seung-Hyun Dec 10, 2019 06:31am
- Korean-made biosimilars are gaining more market share in the anticancer treatment Herceptin (trastuzumab) market. The biosimilars have now taken over more than 25 percent of the market share. The total market size has recovered the previous level, before the original’s price fell with new launches of inexpensive biosimilars. Alhtough Celltrion’s Herzuma showed a steep uptrend, Samsung Bioepis’ Safenet was sluggish with the growth. According to pharmaceutical market research firm IQVIA on Dec. 9, the third quarter the total trastuzumab market reached 26.8 billion won. It soared 24.7 percent from the same period last year. Trastuzumab is a substance used for treating breast cancer and metastatic stomach cancer, and Roche’s Herceptin is the well-known brand name of the substance. In Korea, Herzuma and Samfenet are two available trastuzumab biosimilars. Quarterly market share trend of trastuzumab items (Unit: percentage) Source: IQVIA In the third quarter of 2017, the trastuzumab market plummeted by 30.5 percent to 19.1 billion won, compared to 27.5 billion won made a year before. But the figure climbed back up to the point of two years ago. The biosimilars entering the market triggered Herceptin’s price to drop and shrunk the whole market. When Celltrion’s Herzuma was listed for insurance reimbursement in April 2017, Herceptin’s maximum reimbursed price fell two months later from 517,628 won per 150 mg to 414,103 won by 20 percent in. By the principles of the Korean drug pricing system, a biosimilar itemcan be priced at maximum 70 percent of the original’s initial reimbursed price. From October 2016, a biosimilar item developed by a designated Innovative Pharmaceutical Company, a company passing the designation standard, or Korean and multinational companies in partnership can be priced at maximum 80 percent of the original’s price. The same condition applies to items either first approved in Korea or manufactured locally. The off-patent original item’s price is automatically dropped to around 70 to 80 percent of the initial price when biosimilars item is launched. The recent expansion of the trastuzumab market was leveraged by biosimilars. Herzuma generated 6.3 billion won in the third quarter, increasing the sales by 156.7 percent than same time last year. Herzuma started making sales profit from the third quarter 2017, and it grew consistently and surpassed five billion won mark in last second quarter. The accumulated sales in the third quarter reached 16.2 billion won. Samfenet, on the other hand, was not performing as well as Herzuma. In the third quarter, Samfenet generated about 500 million won. Its sales reached 700 million won in last second quarter, but the figure is coming down again. Daewoong Pharmaceutical is in charge of commercializing Samfenet at the moment. Although Samfenet did not show as satisfying growth, Herzuma’s steep growth took a big bite out of the overall trastuzumab market, expanding the general biosimilars’ pie. The biosimilars took over 25.7 percent of market share in the third quarter with Herzumab taking up 23.6 percent and Samfenet taking up 2.1 percent. In general, a highlight of the trastuzumab market was Celltrion and Samsung Bioepis leading the general growth of the market. 150 mg of Herzuma was listed for reimbursement in April 2017 at the maximum reimbursed price of 372,692 won, about 72 percent of Herceptin’s price before its patent expired. Samsung Bioepis’ Samfenet in 150 mg dose was granted with insurance reimbursement since February last year at the maximum reimbursed price of 291,942 won. It was about 56.4 percent of Herceptin’s initial price. Since then, Celltrion brought down its Herzuma’s reimbursed price by 21.7 percent to 291,942 won to match Samfenet’s price. Trastuzumab’s market volume is now about the same as three years ago. It could be analyzed that patients’ access has been improved and accordingly the medicine use has been increased significantly with reasonably priced biosimilars and the original’s lowered price.
- Product
- Metformin impurity amount, theoretically 1/90 of Ranitidine
- by Kim, Jin-Gu Dec 10, 2019 06:31am
- Molecular structure of MetforminWith Metformin, issues of impurity detection have been raised, and it is possible that N-nitrosodimethylamine (NDMA) will be detected much less than earlier Ranitidine or Nizatidine. According to officials at the MFDS on Dec 9, a qualitative structure activity relationship (QSAR) is used as a simple test to determine the toxicity of a substance. It is a test method that compares and predicts physical and chemical properties by similarity of intrinsic chemical structure. Since the properties of a substance are closely related to its molecular structure, it is a principle that similar physical structures have similar physical properties and toxicity. In fact, the results of predicting the toxicity of Ranitidine-Nizatidine in this way are nearly identical to the actual detection of NDMA in both formulations, according to the MFDS official. According to the official, the results of Ranitidine and Nizatidine QSAR were 90 and 5, respectively. The actual detection amounts were 53.50 ppm and 1.43 ppm based on the maximum values. A MFDS official said, "On this extension, Metformin's QSAR test results are only around 1." It is expected that the possibility of actual detection is much lower than that of Ranitidine or Nizatidine. ◆'Ranithidine 90%, Nizatidine 5%, Metformin 1% or less' This is in line with the findings of Agilent, a US material analysis company. Agilent conducted an experiment in May 2017 to investigate the effects of discarded drugs and chemicals on water pollution. Agilent66 substances were selected for the survey. It includes Ranitidine and Nizatidine, and Metformin. Among the various substances, it is explained that a substance that is likely to be transformed into DMA (dimethylamine) is selected. DMA, together with nitrite, is one of the two materials of NDMA Experimental results showed that the rate of NDMA formation was 60-90% for Ranitidine. Of the 100 ranitidine molecules, 60 to 90 change to NDMA. 5% to Nizatidine. Metformin was found to be less than 1%. This is consistent with the description of the MFDS official. However, as in the case of Valsartan, it is not possible to exclude the possibility that NDMA is generated due to reaction of a specific solvent in the manufacturing process. In the case of Valsartan, dimethylamine was formed as a decomposition product during the high temperature process of dimethylformamide (DMF), which was used as a solvent, and the dimethylamine reacted with nitrite under acidic conditions, leading to NDMA formation. An official from the MFDS explained, “It is difficult to identify the cause of NDMA in Metformin right away, and we have to chop up the molecules of Metformin into small pieces to closely examine the similarity with Ranitidine and the toxicity of the substance itself”. "As a result of the QSAR test, Ranitidine was 90 and Metformin was 1, and A detailed survey of Metformin will be performed and it will be compared with the QSAR test results" said the official.
- Company
- Metformin Self Test, undetected cases also listed
- by Lee, Tak-Sun Dec 10, 2019 06:31am
- The domestic pharmaceutical industry is responding quickly to the issue of Metformin impurities. In some cases, the MFDS has already completed testing, instructing its own testing of raw materials and finished products that may generate impurities. The rest of the companies are considering pushing the test through their own research institute or entrusting the test to outside the university research institute. According to the pharmaceutical industry on the 9th, the Korean pharmaceutical industry conducted its own investigation last Friday (December 6) as the US FDA tests whether it detects carcinogen NDMA (N-Itrosodimethylamine) in the diabetes drug Metformin. The issue began with the detection of more than daily NDMA on three Metformin products in Singapore. The MFDS is investigating the influx of finished Singapore products and raw materials into the country. In addition, it is reported that self-investigation is in the future. Prior to this, domestic pharmaceutical companies began their own tests. The MFDS immediately followed its own investigation of raw materials and finished products that are highly likely to detect impurities, and immediately reports any abnormalities detected. An official from a mid-sized pharmaceutical company said, "We have already tested NDMA for pharmaceutical raw materials through a university lab, and there were no detection results as a result of testing on 3 lots of raw materials using a similar method to the Nizatidine method". Large pharmaceutical companies with high sales of Metformin are also in a hurry to promote their own tests. An official from the company said, "We are planning a test through our own laboratory". Other companies are also making rapid progress, including hearing about the detection of metformin's impurities and promoting their own tests. However, the MFDS does not have any further instructions so it is reported that they are struggling over the countermeasure and test result report. A mid-sized company official said, "We do not know how to report the undetected test results to MFDS and there are no directions from MFDS yet".
