- LOGIN
- MemberShip
- 2026-03-19 06:51:24
- Company
- Fear of unstable Indian API supply spreads with COVID-19
- by Chon, Seung-Hyun Mar 09, 2020 07:59am
- Due to the outbreak of 2019 novel coronavirus (COVID-19), Indian government started limiting the export of active pharmaceutical ingredient. Pharmaceutical companies’ concern of supply shortage is now imminent as COVID-19 could impede pharmaceutical ingredient export from China and India in a long-term. According to industry sources on Mar. 4, the Indian government has decided to restrict the export of 26 active pharmaceutical ingredients (API) as of Mar. 3 (local time), because pharmaceutical shortage they are experiencing with COVID-19. The restricted export list includes pain reliever acetaminophen (paracetamol), vitamin and antibiotics. Indian companies would have to receive the government’s approval to export the APIs. Almost 10 percent of APIs exported from India is on the restricted list. India means to limit the pharmaceutical export before the country is faced with pharmaceutical shortage from COVID-19 outbreak. As most of APIs manufactured in India use chemical substance imported from China, the API manufacturing in India would be affected if China were to struggle exporting the substance due to the outbreak. Restriction on Indian-made API export could affect Korean pharmaceutical industry. API and finished product import volume by year (Unite: USD 1,000) Source: MFDS Korea’s Ministry of Food and Drug Safety (MFDS) said the total import volume of Indian-made pharmaceuticals reached USD 204.13 million in 2018, making it the tenth biggest pharmaceutical exporter to Korea. Although the Indian-made finished product takes up only five percent of overall pharmaceutical market in Korea, the export restriction would still affect Korea as most of the imported products are API used by Korean companies. In 2018, total of 195.59 million dollars of Indian-made APIs was imported, following the top export volume from China and Japan. The Indian API import volume has been constantly increasing over the years. The figure surged by 39.3 percent in seven years, starting from 140.43 million won in 2011. The API import volume from India was at sixth place in 2011, following Japan, China, Italy, Germany and France, but the Korean pharmaceutical industry’s dependency on India has not ceased to grow. Top API exporting countries to Korea by year (Unit: USD 1,000) Source: MFDS Along with Chinese-made APIs, Indian-made imported API volume has gone up the most, mostly because of the low cost. Experts assess Korean pharmaceutical companies have been increasingly preferring APIs from China and India to reduce production cost. Some point out the Korean companies’ demands for inexpensive APIs have soared as the Korean government continuously lowered pricing of finished products and did not sufficiently compensated for their value, while their sales marketing activities have been strained with tightened regulation against illegal rebate. But also, the enhanced quality of Chinese and Indian-made APIs has influenced the companies’ preference. Pharmaceutical companies are now calculating the impact of Indian API export restriction. The companies fear of the direct impact on pharmaceutical manufacturing caused by Indian-made API supply issues, as COVID-19 outbreak has already affected API supply from China. The Korean companies are already struggling with Chinese API supply of stomach ulcer treatment cimetidine. Chongqing Qingyang Pharmaceutical, based in Chongching City, China, has temporarily stopped manufacturing cimetidine API due to the outbreak. As the outbreak is relentlessly spreading, the industry has to prepare for the actual API shortage of some herbal medicinal product ingredients solely depended on China. As a result, pharmaceutical companies would have to seek for other API manufacturing sites to substitute Chinese or Indian-made APIs. Apparently, most of APIs from China and India could be alternatively sourced from either Korea or other countries. However, registering new API is not as easy. MFDS has to approve of the use of currently unregistered imported API, but the ministry has suspended all overseas on-site inspection. Also the companies are worried about increase in production cost by changing the API source. A pharmaceutical company insider complained, “Majority of APIs imported from China and India are substitutable. Although we could use reserved stock of APIs for a while, prolonged COVID-19 outbreak would inevitably cause problem in manufacturing schedule of drug products.”
- Company
- MOHW: “Cancer Committee to be rescheduled in March”
- by Eo, Yun-Ho Mar 06, 2020 06:06am
- The Cancer Deliberation Committee meeting initially canceled due to COVID-19 outbreak would be rescheduled again soon. Pharmaceutical industry sources reported Korea’s Ministry of Health and Welfare (MOHW) plans to review some of drugs on paper, but to conduct vis-à-vis review on significant drugs applying for reimbursement expansion within March. Specifically, major pharmaceuticals like AstraZeneca’s targeted therapy Tagrisso (osimertinib) and Ono Pharmaceutical and Bristol-Myers Squibb’s Opdivo (nivolumab) would resume their reimbursement listing talks. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso is under review for expanding reimbursement as a first-line therapy for EGFR mutation-positive non-small-cell lung cancer (NSCLC). PD-1 inhibitor Opdivo has a number of indications seeking for reimbursement, such as renal cell carcinoma-treating first-line combination therapy with Yervoy, second-line treatment for renal cell carcinoma, second-line treatment for relapsed or metastatic head neck squamous cell carcinoma, and second-line treatment for classical Hodgkin’s disease. But, the controversial indication of second-line treatment for NSCLC regardless of expression of PD-L1 was omitted from the application. Also, Ipsen Korea’s Cabometyx (cabozantanib) was supposed to be deliberated as well. After getting listed as a second-line treatment for advanced renal cell carcinoma last month, Cabometyx has applied for reimbursement on its liver cancer indication as well. The medication also could resolve the issue of Eisai’s Lenvima (lenvatinib) without a second-line therapy option. MOHW official said, “Although the government is hectic with COVID-19 outbreak, we have decided the reimbursement listing review for anticancer treatment cannot wait. The ministry would finalize the schedule as promptly as possible to push on with the listing procedure, including Cancer Deliberation Committee, without a delay.” Meanwhile, MSD’s immunotherapy Keytruda would be excluded from this month’s agenda, but would be included in April’s agenda of the Cancer Deliberation Committee. Keytruda is waiting for the committee to deliberate reimbursement feasibility of its expanded indications. The global company’s listing application included indications for first-line treatment for NSCLC, bladder cancer and Hodgkin’s lymphoma, which have been denied previously, but also two new indications of first-line treatment for metastatic non-squamos NSCLC as a combination therapy with pemetrexed and platinum chemotherapy, and first-line treatment for metastatic squamous NSCLC as combination therapy with carboplatin and paclitaxel were included as well.
- Company
- MFDS clears varicella vaccine license for GC Pharma
- by Lee, Seok-Jun Mar 06, 2020 06:06am
- GC Pharma announced on Mar. 4 its chickenpox vaccine ‘Varycella’ injection has recently won an item license from Ministry of Food and Drug Safety for the Korean market. Like other existing chickenpox vaccines, the company stated Varycella is a live attenuated varicella virus vaccine. The Korean company was able to push up the production yield significantly by improving the productivity. And also it increased the content of live varicella virus and enhanced stability of the product as well. In Phase III transnational clinical trial conducted in Korea and Thailand with infants aged either over or under 12 months, Varycella injection confirmed its non-inferiority against reference vaccine. GC Pharma aims to penetrate the USD 2.3 billion-worth global varicella vaccine market with Varycella injection. The Head of Development Department at GC Pharma, Lee Jaewoo said, “We are committed to contribute to lessen the social strain and cost of varicella prevalence around the world by providing upgraded varicella vaccine. Besides supplying to the Korean market, the company plans to target the global market after passing the World Health Organization’s Prequalification (PQ).”
- Company
- Industry fears sales ban as NDMA risk in metformin rekindled
- by Chon, Seung-Hyun Mar 06, 2020 06:06am
- The risk of impurity found in metformin could resurface due to another warning from the U.S.-based private research firm. The pharmaceutical industry’s concern deepens as the same research firm that warned about ranitidine risk last year published the metformin analytic data. Already pharmaceutical companies fear global health authorities would order a complete sales ban on metformin after they collect and probe the products. ◆ Valisure “16 out of 38 metformin batches showed NDMA exceeding acceptable level” According to industry sources on Mar. 3, Valisure, a private research institute based in the U.S., has detectd cancerous N-nitrosodimenthylamine (NDMA) exceeding acceptable level of daily intake in some metformin products, which used in the U.S. as antidiabetic drugs. Valisure investigated NDMA in 38 metformin production batches manufactured by 22 pharmaceutical companies, following the liquid chromatography-mass spectrometry (LC-MS) protocol. Apparently, Valisure has found NDMA exceeding acceptable level of daily intake in 16 batches from 11 companies. One of the batches had NDMA content level 16.5 times higher than the acceptable daily intake level of 96 ng. Valisure has requested the U.S. Food and Drug Administration (FDA) to recall the metformin products containing levels of NDMA in excess of the daily acceptable intake limit. Valisure’s list of metformin production batch found containing NDMA exceeding the acceptable level of daily intake (96 ng) (Source: Valisure Citizen Petition on Metformin) The analytic findings from the firm contrast from the statement issued a month ago by FDA. On Feb. 3, the U.S. health regulator informed their analysis on 10 metformin products distributed in the U.S. market found two products with low level of NDMA content, which the regulator recommended not to use. ◆ Industry tenses up as Valisure warned of risk of ranitidine and nizatidine last year The pharmaceutical industry is keenly watching the private research firm, because Valisure first warned of impurity found in ranitidine last year. Housed in New Haven, CT, Valisure operates online pharmacies in 38 states in the U.S. and regularly publishes analytic findings regarding pharmaceutical safety. Interestingly, Valisure’s metformin impurity risk warning is similar to the actions taken for ranitidine impurity risk. FDA issued a statement last year announcing the presence of low levels of NDMA in ranitidine drugs like Zantac, but did not mention a specific plan to recall the product. Since then, Valisure disclosed their own investigation showing high levels of NDMA in ranitidine drugs including Zantac, and requested FDA to recall the products. As a result, majority of ranitidine drugs were detected with unacceptable level of NDMA and the drugs were recalled in the U.S. and Europe. Valisure also urged FDA to initiate investigation on nizatidine by presenting findings of NDMA in the drug. Korea’s Ministry of Food and Drug Safety (MFDS) also decided to ban sales and recall 13 nizatidine products in last November due to the presence of excessive level of NDMA. Such development of the decisions by global health regulators is the reason the pharmaceutical companies are tensed up about MFDS’ actions following the metformin analysis. The risk of NDMA in metformin was first raised from Singapore. On Dec. 4 last year, Singapore’s Health Sciences Authority (HSA) recalled three items out of 46 metformin-containing drugs they have tested. The result confirmed high levels of NDMA exceeding the acceptable daily intake level. MFDS is currently probing NDMA in metformin active ingredient and finished products. Although it has already been three months since the Singaporean health regulator spoke of the risk in metformin, the Korean ministry has not yet revealed the investigation outcome. In last December, MFDS had pharmaceutical companies to submit record of using metformin. And on Jan. 15, the ministry presented NDMA testing methodology for metformin. The ministry is still probing NDMA contamination in collected active metformin ingredients. Over a month has passed since FDA has presented the interim result of metformin-NDMA investigation, but the Korean health regulator has not even mentioned of a next step. Three days after the news of Zantac detected with NDMA in the U.S., MFDS announced interim test result of NDMA level in Zantac on last Sept. 16 and said the impurity has not been detected. But for the ranitidine issue, the Korean government ordered sales ban on the product in a mere of 10 days. MFDS official stated, “Currently an inspection on contamination in metformin is ongoing.” The ministry is reviewing NDMA contamination in over 900 metformin samples. ◆ Pharmaceutical companies anxious of stringent actions like ranitidine or valsartan risk Clearly, the pharmaceutical industry is edgy on the MFDS-confirmed level of NDMA in metformin from Korea and their response, because Korean regulator’s action on NDMA-detected drug so far has been more stringent than that of the U.S. or European regulators. MFDS has banned sales of finished product that used the controversial active ingredient at least once since January of 2015. Many of the products were probably banned from the market even if the controversial active ingredient was not used recently. In the U.S., only the products using active ingredient from Zhejiang Huahai Pharmaceutical were recalled by batches. An order of complete sales ban on the product was never given. The level of action taken by European health regulator was on par. While every ranitidine product was banned in Korea, pharmaceutical companies voluntarily recalled the products by batches in the U.S. and Europe. Whereas 13 nizatidine products were banned from sales in Korea, Japan only recalled a number of the products and the U.S. and Europe have not given a recall order. The Korean regulator has decide to recall specific batches of nizatidine with high levels of NDMA, but those products were temporarily banned from sales until the recall was completed. Valisure pointed out the level of NDMA in metformin varies depending on each batch, although they were manufactured by a same company. They argued the pharmaceutical substance could be the unstable factor. The MFDS’ decision to weed out ranitidine products was made because ‘ranitidine has an unstable quality, therefore, it is always exposed to the risk of generating NDMA.’ A tremendous chaos in the whole of pharmaceutical industry would be inevitable if the ministry is to take actions as stringent as before when it finds high levels of NDMA in some of metformin. According to pharmaceutical market research firm UBIST, pharmaceuticals with metformin generated 473.2 billion won last year from outpatient prescription. The market continues to grow as the volume has doubled since 2014. Pharmaceutical companies argue the Korean regulator should take similar level of actions as the U.S. or Europe, even if they find high levels of NDMA in some of metformin available in Korea. Especially because a research was published claiming NDMA found in valsartan and ranitidine would not be harmful to human body. In last December, MFDS stated, “Reviewing individual dose and administration period of patients actually taking finished product containing valsartan manufactured from Huahai Pharmaceutical with NDMA, the possibility of causing cancer was low enough to ignore.” FDA also issued a statement last November, “The risk of causing cancer by NDMA detected in ranitidine is close to the risk exposed from having barbecued meat or smoked meat.” A pharmaceutical company insider urged, “Regardless of unconfirmed harm of pharmaceuticals detected with NDMA, the produces were banned from sales and recalled. Accordingly, pharmaceutical companies had to endure immense loss and the public’s apprehension has deepened. On products with impurities found in the future, the Korean government should order a batch-basis recall like the U.S. and European government have.”
- Company
- 86% of generics for erectile dysfunction are domestic
- by Chon, Seung-Hyun Mar 05, 2020 06:33am
- The sales rate of generic products developed in Korea in the erectile dysfunction market is very high. Hanmi pharm's Palpal is one of hottest items, and Chong Kun Dang's Cendom continued to rise. Domestically developed drugs account for 86% of the erectile dysfunction drug market, and the influence of domestic products is expanding. According to IQVIA, a drug research agency on the 2nd, the market for erectile dysfunction drugs last year was 5.3%, up 5.3% year-on-year. It is growing continuously every year, from ₩98 billion in 2016 to ₩104.5 billion in 2017 and ₩108.2 billion in 2018. Hanmi's Palpal still showed its unrivaled position in the market. Palpal's sales last year were up to ₩22.4 billion, an increase of 7.0%. In the overall market for erectile dysfunction drugs, Palpal's market share is nearly 20%. Palpal, which was released shortly after Viagra's patent expired in 2012, sells most since beating Viagra in 2013 and Cialis in 2015, respectively. Sales of Major Erectile Dysfunction Therapeutics (Unit: KRW million,%, Source: IQVIA) Palpal has more than doubled the sales of its original product, Viagra (₩9.6 billion). Considering that Palpal is less than half the price of Viagra, it can be calculated that the actual sales volume is more than four times. In recent years, Chong Kun Dang's Cendom (generic for Cialis) sells well. Cendom sold ₩10.4 billion, up 8.7% from last year. Among the total erectile dysfunction treatment products, Cendom is the only product that has exceeded annual sales of ₩10 billion. Cendom, which was released after the Cialis patent expired in September 2015, gradually surpassed Cialis in 2017 as its market share gradually increased. Last year, it was overtaking even Viagra. Hanmi Pharm The progress of Hanmi Pharm's Gugu (generic for Cialis) was also noticeable. Gu gu's sales reached 4th place last year, reaching ₩7 billion, an increase of 13.7% over the previous year, and it beated Cialis for the first time since release. Three generics including Palpal, Cendom, and Gugu, accounted for more sales than the original drugs. Viagra and Cialis continued to decline last year, beghind in generics. Viagra's sales last year were ₩9.6 billion, down 2.3% year-on-year. Cialis fell 1.0% from ₩6.5 billion in 2018 to ₩6.4 billion last year. Among domestically sold erectile dysfunction treatment products, there are two products of Viagra and Cialis, and they sold a total of ₩16 billion last year. Bayer's Levitra announced the withdrawal of the domestic market in April. New drugs and generic products released by domestic companies account for a total of 86.0%. After 83.3% in 2017 and 84.8% in 2018, the market share is increasing. Domestically developed new drug products, such as SK Chemicals' 'Mvix' and 'Mvix S', and Dong-A ST's 'Zydena', also generate annual sales of ₩6 billion. In the domestic pharmaceutical market, generics continue to strengthen in the erectile dysfunction treatment market. In general, it is extremely unusual for generics to exceed sales of original drugs. That's because it's not easy for generics to surpass the reliability established by original products over time. Recently, in Korea, new drugs whose patents of multinational pharmaceutical companies have expired are increasing. According to UBIST, Last year, Lipitor’s outpatient prescription amount was ₩17.6 billion, an increase of 8.4%. Since 2014, the prescription amount have risen for six consecutive years. Sanofi's anti-thrombotic drug Plavix, last year's prescription performance was ₩88.9 billion, an increase of 17.3%. Prescription amount for Plavix increased 28.1% in two years from ₩69.4 billion in 2017. Original drugs, such as AstraZeneca's Crestor, Boehringer Ingelheim's Twynsta, Ezai's Aricept and Novartis' Exforge, also showed a rise in prescriptions from last year. Due to the nature of the original drug and generic insurance cap, the focus on the original increases. On the other hand, in the non-reimbursed drug market, where suppliers such as erectile dysfunction drugs set the price, it is analyzed that generics have increased their market share by aggressively operating at lower prices than the original drugs. Looking at the sales of erectile dysfunction treatments by company, Chong Kun Dang is facing a challenge to Hanmi Pharm. Sales Trend of Erectile Dysfunction Therapeutics by Company (Unit: KRW 1 million,%, Source: IQVIA) Hanmi Pharm recorded 25.8% of the total market last year with sales of ₩29.4 billion with Palpal and Gugu. The gap was widened with latecomers with a growth rate of 8.5% year-on-year. Chong Kun Dang recorded 6.1% year-on-year growth with the joint venture of ₩11.3 billion in three generics: Cendom, Cengla, and Yaila. Chong Kun Dang succeeded Hanmi Pharm with a 11.5% market share. Chong Kun Dang is gradually expanding its influence in the Viagra market even though it has fallen behind competitors. Chong Kun Dang signed a business alliance with Bayer in 2007 and renamed Levitra under the name of Yaila, failing to enter the Viagra generic market in 2012. Chong Kun Dang entered the Cialis market shortly after clearing his partnership with Bayer in 2015, and in 2017 launched Cengla, generic for Viagra, five years later than its competitors. Cengla's sales last year stood at ₩1.9 billion, ranking third among the generics for Viagra after Palpal and Nurigra. In 2018, Chong Kun Dang was licensed under Yaila, which previously sold Levitra. Chong Kun Dang is the only company that has all three generic drugs for erectile dysfunction. Pfizer made a joint venture between Viagra and Viagra L film last year at ₩10.1 billion. Chong Kun Dang was the second-largest market share, down 3.3% from the previous year. Sales of two types of erectile dysfunction treatment drugs, SK Chemicals and Daewoong Pharmaceuticals, exceeded Cialis, and ranked 4th and 5th, respectively.
- Company
- Janssen Korea breaks through KRW 300 bln for the first time
- by An, Kyung-Jin Mar 05, 2020 06:33am
- Janssen Korea’s yearly sales revenue (left) and operating profit (right) (Unit: KRW 100 million) Source: Financial Supervisory Service and Yuhan IR Janssen Korea broke through the 300 billion won-line in Korea for the first time. Leveraged by outstanding performance of star products like Remicade, Simponi and Stelara, the global pharmaceutical company manifested impressive sales revenue and operating profit. According to performance data of last fourth quarter provided by Yuhan on Mar. 2, Janssen Korea has made overall 311 billion won last year with 17.5 percent increase from the previous year. 36 years since the Korean office was founded, Janssen Korea has for the first time generated more than 300 billion in a year. The operating profit was surged by 111.7 percent and reached 37.9 billion won. Compared to 38.7 billion won made in 2007, last year was the second most profitable year. However, the figure could change in coming months as it is from tentative data before an audit by an accounting firm. According to the partnership investment deal inked between Yuhan and the U.S.-based Johnson and Johnson (J&J) in May of 1983, Janssen Korea was established. J&J owns 70 percent of the share (746,760 shares), and Yuhan as a second largest shareholder owns the rest of 30 percent (320,040 shares) of the share. Due to equity method, Yuhan has been disclosing its associate, Janssen Korea’s business performance via quarterly IR data since the second quarter of 2014. Yuhan receives a set ratio of dividend from Janssen’s net profit. Yearly sales revenue of Janssen Korea’s major pharmaceutical products (Unit: KRW 100 million) Source: IQVIA Autoimmune disease treatments like Remicade (infliximab), Simponi (golimumab) and Stelara (ustekinumab) have led the massive revenue hike. Pharmaceutical market research firm IQVIA found the three products have generated total of 99.3 billion won last year with 14.1-percent increase. Compared to 2015, the revenue volume has leapt by 93.3 percent. The sales revenue of interleukin antagonist Stelara showed the steepest surge. Making 22.2 billion won last year, Stelara’s sales volume was boosted by 54.2 percent. The figure has quadrupled since 2015. The company’s top seller, Remicade also made 46 billion won last year with 2.0-percent increase than the year before. Although the yearly increase was not so significant, Remicade is the company’s biggest cash cow as it leads the TNF-alpha inhibitor market in Korea. Remicade’s follow-on TNF-alpha inhibitor Simponi has been absorbing the market share fast since its release in 2013. Simponi also climbed up 13.0 percent last year and generated 31.0 billion won. The medication, available in both subcutaneous and intravenous injections, stepped up above Pfizer’s Enbrel and sold the third most volume in the TNF-alpha inhibitor market.
- Company
- Boryung Bio releases 'self-sufficient' quadrivalent vaccine
- by An, Kyung-Jin Mar 05, 2020 06:33am
- Boryung DTaP-IPV Vaccine On Mar. 2, Boryung Biopharma announced the release of ‘Boryung DTaP-IPV Vaccine’ for infants and children. ‘Boryung DTaP-IPV Vaccine’ is a quadrivalent vaccine consisting of DTaP vaccines preventing diphtheria, tetanus and pertussis and inactivated polio vaccine (IPV) against poliomyelitis. Total six doses is required when administering single DTaP vaccine and IPV separately on six-month-old or younger infants, but the combination vaccine could ease the administration by reducing the number of dose down to three. Boryung Biopharma official claimed, “For the first time as a Korean pharmaceutical company, the company has successfully manufactured DTaP-IPV combination vaccine in its own production facility.” As DTaP-IPV combination vaccine requires infants to get shots exactly at second, fourth and sixth month, securing a stable supply of the vaccine is crucial. The combination vaccine has been only supplied by multinational companies and some infants have reportedly missed the right timing of the immunization as vaccine supply was unavailable due to problem in importing procedure or distribution channel. Seven years since the pipeline was set on, Boryung Biopharma was able to develop and manufacture self-sufficient ‘Boryung DTaP-IPV Vaccine.’ According to the provided data, the Korean company has initiated four-year-long transnational clinical trial, including Korea, and confirmed equivalent level of efficacy with compared group in first and second efficacy evaluation. And adverse drug reaction or event did not show significant difference. Based on the clinical result, the Korean-manufactured combination vaccine won Ministry of Food and Drug Safety’s (MFDS) approval last August. Vaccine Division of Boryung Biopharma stated, “Made in Korea’s first ever vaccine manufacturing facility, the newly released ‘Boryung DTaP-IPV Vaccine’ would provide essential vaccine supply. We hope to contribute in reducing medical industry’s struggle with insufficient supply of DTaP-IPV vaccine and in easing the immunization process for infants and their parents.” From last January, National Immunization Program (NIP) has included ‘Boryung DTaP-IPV Vaccine.’ Infants aged two, four and six months may receive free shots of the vaccine at a public health center or designated medical institute in Korea.
- Company
- BMS-Celgene merger restructures Korean office
- by Eo, Yun-Ho Mar 04, 2020 06:27am
- The basic frame of Bristol-Myers Squibb (BMS) and Celgene’s merger company has been unveiled. Recently, BMS presented a newly formed division and appointed the head of Business Unit for the merger. The Commercial Business Unit, including marketing and sales, would undergo the biggest change. BMS has decided to integrate BMS’ existing Oncology division and Celgene’s Hematology division based on the latest reorganization decision. As a result, various anticancer immunotherapies, including Celgene’s star product Revlimid (lenalidomide), multiple myeloma pipeline and BMS’ Yervoy (ipilomumab) and Opdivo (nivolumab), would be promoted under a single Business Unit. The merged Oncology and Hematology Business Unit would be led by Senior Direct Lee Seunghun, who used to lead BMS’ Oncology Unit. Medical Affairs division has been integrated as well. Similar to Marketing and Sales divisions, individual account executives would take over multiple myeloma, lymphoma and anticancer treatment under the single roof of Medical Affairs division. As for the heads of Market Access division and Corporate Affairs division, Executive Director Yeo Dongho (a former Market Access manager at Celgene) and Senior Director Park Kye-hyun were appointed, respectively. Government Affair division and other business support divisions would maintain the existing system. The newly merged BMS-Celgene company would house the Region Office within ‘China & Asia Cluster Office,’ located in Singapore. The company’s China & Asia Cluster Market has welcomed Jesus Acebillo, originally from Novartis, as a new CEO.
- Company
- Whan In has signed domestic monopoly rights of 'Cariprazine'
- by Jung, Hye-Jin Mar 04, 2020 06:27am
- Whan In Pharm (CEO Won-bum Lee) announced on the 2nd that it has signed an exclusive contract to introduce Cariprazine, a schizophrenic drug from Gedeon Richter, Hungary. Under this contract, Whan In Pharm is responsible for commercializing, distributing and selling products such as domestic clinical trials and product approval of Cariprazine. Gedeon Richter will supply to Whan In. Cariprazine is a once-daily oral medication for schizophrenia, currently approved and released in 15 countries including the United States and Europe. The U.S. product name is 'Vraylar' and the European product name is 'Reagila'. Cariprazine is sold by Allergan in the United States as a treatment for adult type 1 bipolar disorder and schizophrenia. In Europe, it is approved for the treatment of adult schizophrenia and is sold by Recordati and Gedeon Richter. Won-bum Lee, CEO of Whan In Pharm, said, “We will build a partnership with Gedeon Richter to further strengthen neurology and Psychiatry influences of Whan In Pharm, and we are pleased to offer new treatment options to Korean medical staff and patients through Cariprazine”.
- Company
- In the aftermath of the COVID-19, the BA test was disrupted
- by Chon, Seung-Hyun Mar 04, 2020 06:27am
- COVID-19 infections have also influenced the generic development strategies of pharmaceutical companies. Due to the risk of infection with COVID-19, the bioequivalence task of medical institutions has been disrupted. This is an embarrassing situation for pharmaceutical companies that are conducting bioequivalence tests to reduce drug prices ahead of the reform of the generic drug price system. They are concerned whether the new generics' approval schedule may be delayed or the authorization for drug price maintenance will affect the generic bioequivalence test. According to the industry on the 1st, H Plus Yangji Hospital recently announced the suspension of bioequivalence testing due to the spread of COVID-19 to pharmaceutical companies and analysis agencies. Yangji Hospital has decided to suspend face-to-face testing related to bioequivalence tests, including first-dose monitoring, screening, monitoring, and initiation meeting, by March 15. Tests that have been completed on stage I will proceed normally. Although there were no COVID-19 confirmed patients at the hospital, the company decided to minimize face-to-face work to prevent infection. Yangji Hospital said, “We have made a lot of efforts to conduct a safe test in accordance with the spread of COVID-19, but decided to suspend the work on our own because it is too dangerous”. Yangji Hospital is a medical institution where the largest number of generic bioequivalence tests are conducted in Korea. Last year, 190 of 259 approved bioequivalence studies were performed at Yangji Hospital. Three out of four bioequivalence studies are in charge of Yangji Hospital. Yangji Hospital performed 116 of the 178 approved bioequivalence studies in 2018, accounting for 65.2%. Many medical institutions, except Yangji Hospital, are reportedly conducting bioequivalence testing, such as medication and blood collection. However, if the spread of COVID-19 accelerates in the future, the possibility of business disruption is raised. As a result, pharmaceutical companies are inevitable on generic development strategies. In particular, the development of new generics in preparation for the reform of the drug price system and the strategy of licensed generics may also be affected. The revised drug price plan, which is scheduled to be implemented in July, has the key point that the company must maintain the upper limit of 53.55% compared to the original before the expiration of the patent only when both the bioequivalence test and DMF. Whenever one requirement is not met, the upper limit drops by 15%. In the case of registered generics, the upper limit can be maintained at 53.55% if the bioequivalence test and DMF requirements are met within three years. In the case of new generic drugs, if they do not carry out direct bioequivalence tests, they will receive lower prices than before. The prolonged discontinuation of bioequivalence testing could be a variable in the plan to get higher prices for new generics. There is also same situation with licensed generics. Pharmaceutical companies can maintain their existing high prices only after conducting bioequivalence tests and judging suitability prior to July 2023 for generics licensed under preconditioning. Indeed, pharmaceutical companies are aggressively undertaking bioactivity testing. Approval Status of Monthly Bioequivalence Test Plan (Unit: Case, Source: the Ministry of Food and Drug Safety) According to the Ministry of Food and Drug Safety, 26 bioequivalence plans approved last month were up 85.7% year-on-year. A total of 44 bioequivalence plans were approved in January and February this year, 13 more than 31 January and February last year. A total of 91 bioequivalence plans were approved in the first half of last year, and increased significantly to 168 in the second half of last year. Licensed generics are actively tested. It is a bioequivalence test for the purpose of changing a manufacturer to produce generics approved by a consignment directly in its own manufacturing facility. If the biopharmaceutical test is conducted with generics produced through the drug product research and the equivalent result is obtained, the drug price reduction can be avoided through the change permit. Some pharmaceutical companies are considering launching bioequivalence trials for as many as tens of generics. The delay in the schedule of bioequivalence due to the spread of COVID-19 is a burden. An official of a pharmaceutical company said, “If the COVID-19 situation is prolonged, and the long-term interruption of bioequivalence testing will affect the generic development strategy and in addition to generics, it is also a concern to conduct normal clinical trials of new or improved drugs”.
