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- 2026-04-16 14:43:37
- Policy
- NHIS expects avg 322 generic pricing negotiations per month
- by Lee, Hye-Kyung Jul 13, 2020 06:12am
- Korea’s National Health Insurance Service (NHIS) is to start negotiating with generics over healthcare reimbursement contracts from the second half of the year. At a press conference convened on July 7, NHIS Reimbursement Executive Director Kang Chung-hee stated, “For the pricing negotiation on generics to be conducted from August to September, the Drug Pricing System Improvement Division previously operated under one team of six staffs in one division would be expanded to two teams of nine staffs in one division.” According to the deliberations done by Health Insurance Policy Deliberation Committee (HIPDC) from last year January to last March, average 322 generic items would be negotiated for pricing every month. When NHIS initiates pricing negotiation with generic, pharmaceutical companies would have a preliminary consultation with NHIS regarding negotiation and contract compliance as they submit an application for reimbursement listing to Health Insurance Review and Assessment Service (HIRA). After HIRA calculates drug pricing, the pursuing company should engage in a pricing negotiation with NHIS for 60 days and a deliberation by HIPDC before the final announcement of listing and pricing is made. Director Kang said, “The negotiation process would be streamlined through preliminary consultation with pharmaceutical companies,” and “the contract would become the focal point of the generic supply and quality management.” For the process, NHIS held a meeting on July 8 with Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), Korea Biomedicine Industry Association (KoBIA) and Korean Research-based Pharmaceutical Industry Association (KRPIA). At the meeting, NHIS explained about detailed guidelines of revised ‘Regulations on National Health Insurance Reimbursement Criteria’ and ‘Pharmaceutical Decision and Adjustment Standards,’ which mandate a 60-day drug pricing negotiation on generics listed through authorized pricing calculation, instead of pricing negotiation. Answering the industry representatives’ concern on the pricing negotiation delaying the listing process, Director Kang said, “The Ministry of Health and Welfare would decide on the detailed guideline,” and “the delay would be minimized by conducting a preliminary consultation first.”
- Policy
- Clarifying the conditional approval target
- by Lee, Tak-Sun Jul 13, 2020 06:12am
- Chief Ho-sang Jeong (left) & team leader Jeong-won Oh (right), who conducted briefings with the reporters on the 7thThe MFDS strictly enforces the Advanced Bio Act (the Act on the “Safety and Support of Advanced Regenerative Medical and Advanced Biopharmaceuticals”), and said that concerns about safety are only a concern. However, the conditional approvals subject to the enacted legislation will maintain the previous conditions. Ho-sang Jeong, chief of the Cell Gene Therapy Products Division, and Jung-won Oh, leader of the permission team of the MFDS, who is in charge of the screening and licensing parts of the cell and gene therapy products, said in a press briefing on the 7th. On August 28, the MFDS issued an administrative notice by setting up 'Regulations for Permit and Examination of Items for Advanced Biologics' prior to the implementation of the Advanced Bio Act. Accordingly, advanced biopharmaceuticals such as cell therapies and gene therapies that have been applied to the existing the pharmaceutical affairs law will be subject to the new regulations within the framework of the new law. Although the number of licensed items for cell and gene therapies in Korea is small, it is a new kind of treatment, and there are many items developed by listed ventures, which is of interest. In addition, the necessity for strengthening the permit screening is being raised through the case of Invossa, a gene therapy product that has been canceled. Some are also raising concerns about whether drugs subject to expedited review or drugs subject to conditional approval, such as exemption of a phase III, will be screened with neglecting safety. In response, the MFDS explained that safety measures were faithfully reflected in the law to prevent safety problems. For example, a follow-up management system, such as a long-term follow-up survey, was established. ""In fact, even before the law was enforced in August, the screening system for cell and gene therapies was prepared similarly to the standards of developed countries," said Ho-sang Jeong. He said, "The Advanced Bio Act supports high-tech biopharmaceuticals while strengthening safety at the same time, and the rapid review regulations that existed at the public notice level have been enacted, so that the drugs subject to rapid review can be approved within a short period of time." In the meantime, "the criteria for rapid review or conditionally approved products have been clarified, so that there are no concerns about safety due to the misuse of conditionally licensed medicines at some point." He added, "The management became tighter while clarifying the measures for under-conditional items." The MFDS is also considering the input of screening personnel tailored to this. The conditional approval was mainly a system to conditionally phase III clinically and approve items in phase II completion. It was possible because there were no existing treatments, significant life-threatening diseases, or endpoints that could predict clinical benefit. However, these conditions were abstract, and there were few cases where conditionally approved drugs were actually used in patients. The MFDS recognized this problem and explained that the Advanced Bio Act clarified the requirements for conditional approval or expedited examination. Accordingly, it is expected that there will be fewer cases of disagreement over the conditional approvals with companies. The MFDS recently filed a lawsuit against Pharmicell for a conditional license for 'Cellgram-LC' and lost it. However, it is the policy that the conditional permits and pre-licensed items will maintain the previous conditions. The Advanced Bio Act states that licensed items must be re-applied within one year after promulgation. Accordingly, 16 items of cell therapy products must be re-applied. Some of these items are licensed under the condition of phase III. "The three items are conditionally approved under the premise of phase III clinical trials, and the items under phase III clinical trials are planned to maintain the existing license conditions until the re-application is made," said Jeong-won Oh. "On the 3rd, the information submitted to companies with re-permitted items was guided. Basically, safety and effectiveness data have similar requirements according to the pharmaceutical affairs law. They have to submit the data in CTD version," he explained.
- Policy
- Mixed responses on exempting PE for antibiotics
- by Eo, Yun-Ho Jul 10, 2020 06:14am
- The people are voicing both positive and negative reactions on the pharmacoeconomic evaluation (PE) exemption track opened to antibiotics. Considering the unique characteristic of the drug, expanding the coverage on antibiotics with the difficulty of conducting PE is an improvement. But there is a dispute brewing on the definition of antibiotics. In March, Korea’s Ministry of Health and Welfare (MOHW) and Health Insurance Review and Assessment Service (HIRA) preannounced the revised regulation of pharmaceutical healthcare reimbursement subject evaluation criteria and procedure, and started accepting relevant public opinion. The noticeable changes in the regulation related to PE exemption track is expanding the subject scope, currently limited to rare disease only, to include tuberculosis treatment, antibiotics, and emergency antidotes essential to promote public health. ◆A definition of antibiotics could cause confusion The controversial issue is in the definition of ‘antibiotics,’ which could get limited to ‘antibacterial.’ Apparently, the government has expressed intention to positively review the issue as raised by Korean Research-based Pharmaceutical Industry Association (KRPIA). As a medical term, antibiotics means ‘antimicrobial medicine’ functioning as ‘antibacterial (treating bacterial infection),’ ‘antifungal (treating fungal infection),’ and ‘antiviral (treating viral infection).’ And constant rise of antimicrobial resistance (AMR) has been addressed as the most alarming public health issue around the world. Usually, many people interchangeably use the term antibiotics as antibacterial or antimicrobial. But medically speaking, drugs used to impede growth of microbe, like bacteria, fungus and virus, are categorized as antimicrobial medicines. President Choi Jung Hyun (Infectious Disease Division of the Catholic University of Korea Eunpyeong St. Mary’s Hospital) of Korean Society for Antimicrobial Therapy (KSAT) said, “As PEs were conducted without full understanding of newly developed antibiotic and antifungal drugs targeting antibiotic-resistant bacteria, which cannot be treated with other existing options, the drugs were impossible to enter the Korean market. The sources of infectious diseases like bacteria, fungus and virus should be handled by taking in account of possible development of AMR during treatment. ◆The background of introducing PE exemption track on antibiotics The objective of revising the regulation is to revisit some of criteria in PE exemption track to include drugs, challenged to produce PE results but essential to public health improvement. The clinical trial on antibiotics tests non-inferiority against a reference drug. As antibiotics have to treat infectious disease, it is unethical to confirm superiority or to use a drug with developed AMR and diminished treatment effect as a reference drug to confirm superiority. Under such circumstances, PE has been pointed out as the cause of delay in listing antibiotics regardless of the high medical needs. The industry highly anticipates the revised PE exemption benefit would contribute in promptly and reliably supplying new antibiotic and antifungal drugs to Korean market. The U.S. Food and Drug Administration and the European Medicines Agency (EMA) also approve new antibacterial and antifungal drugs based on non-inferiority clinical trial results. President Choi stressed, “We would like to express our appreciation for the government’s effort to secure infectious disease treatment crucial in responding against severe infection seriously threatening the public health. The regulation revision would provide the foundation to have stable access to antibiotic and antifungal drugs to treat antibiotic-resistant bacteria. It would also be a great help for developing the antimicrobial stewardship and resistant bacteria practice guideline the academic society is leading.” Introduced in 2015, the PE exemption track, also known as ‘special PE benefit,’ excludes rare disease treatment or anticancer treatment from the PE data submission requirement, a part of pharmaceutical reimbursement review process. The drugs listed with PE exemption track are applied with expenditure cap type risk sharing agreement (RSA). However, the public has been constantly demanding for the PE exemption subject to expand as drug other than anticancer or rare disease treatment struggling to prove the cost-effectiveness. This marks the first revision made since the system was established in 2015.
- Policy
- Dongkuk's DKF-313 entered clinical trial phase III
- by Lee, Tak-Sun Jul 10, 2020 06:13am
- The prostate hyperplasia complex developed by DongKook Pharmaceutical enters Phase III clinical trials. YuYu Pharma is also developing the same prostate hyperplasia complex, which attracts interest in the competition between the two companies. On the 9th, the MFDS approved the clinical trial phase III trial (IND) for 'DKF-313', which DongKook Pharmaceutical applied for. DKF-313 is known as a combination of Dutasteride and Tadalafil currently used in prostatic hyperplasia. This trial is a multicentre, randomized, double-blind, double placebo, parallel group, phase III clinical trial to evaluate the efficacy and safety of DKF-313 in 654 patients with benign prostatic hyperplasia. The test will be conducted at Asan Medical Center. Dutasteride-Tadalafil combinations are currently not commercially available. It will be the first in the world If developed. YuYu Pharma was approved for a phase III clinical trial plan for 'YY-201,' a candidate for the same ingredient in March 2018. Therefore, it is noted who will succeed in commercialization first. The size of the domestic prostate hyperplasia treatment market is about ₩200 billion , and the original drugs of foreign pharmaceutical companies occupy most of the market share. Representative drugs include Harnal (Tamsulosin HCl, Astellas Korea), Avodart (Dutasteride, GSK), and Proscar (Finasteride, MSD). Tadalafil (Cialis, Lilly) is more famous for erectile dysfunction, but is also used for benign prostatic hyperplasia in low doses. For reference, Dutasteride is effective for prostate hyperplasia as well as hair loss. Therefore, if a combination drug is developed, it is expected that it will be spotlighted in patients with erectile dysfunction and hair loss accompanied by prostate hyperplasia. It seems to be the key to commercialization whether it is possible to increase the solubility of the two components in a single formulation in view of the fact that Dutasteride is a poorly soluble drug that is insoluble in water.
- Company
- General hospitals to prescribe Jeil Pharmaceutical Lonsurf
- by Eo, Yun-Ho Jul 10, 2020 06:13am
- Major general hospitals in Korea are readying prescription of Jeil Pharmaceutical’s Lonsurf indicated to treat patients with colorectal cancer. According to pharmaceutical industry sources, Lonsurf (tipiracil/ trifluridine) has been passed by drug committees (DCs) at the Big Five—Seoul National University Hospital, Samsung Medical Center, Seoul Asan Medical Center and Severance Hospital. Jeil Pharmaceutical won the sales license in Korean market over Lonsurf from Japan-based Taiho Pharmaceutical. The drug is indicated to treat patients with metastatic colorectal cancer previously treated with fluoropyrimidine‑, oxaliplatin‑ and irinotecan‑based chemotherapy, an anti‑vascular endothelial growth factor (VEGF) biological therapy, and an anti‑epidermal growth factor receptor EGFR therapy (if confirmed as RAS wild type). It was approved for Korean market in October last year. The drug uses tipiracil to inhibit thymidine kinase that breaks down trifluridine to maintain the blood concentration. A clinical study confirmed Lonsurf’s statistically meaningful improvement in overall survival (OS) against the best supportive care and the treatment meeting the primary clinical endpoints. The drug’s safety was also confirmed in another clinical study conducted previously. As of 2016, according to Korea Central Cancer Registry (KCCR) report, the number of patients diagnosed with colorectal cancer in Korea reached 28,127, coming second after stomach cancer. And the demand for drugs to be used in patients, who do not respond to standard of care, is rising. Specifically, Lonsurf is taking the limelight as a new treatment option that meets the demand. Lonsurf is approved in 75 countries and regions around the world including Korea as a treatment for metastatic colorectal cancer. In last year, the drug was also indicated to treat metastatic stomach cancer in the U.S., Japan and Europe. The drug globally generates approximately USD 30 million. The U.S. National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO) guidelines respectively recommend Lonsurf as ‘Category 2A’ and ‘Level 1/ Grade B’ to patients with metastatic colorectal cancer who have failed to respond to standard of care.
- Company
- 66 companies complain choline alfoscerate coverage reduction
- by Jul 10, 2020 06:13am
- A group of pharmaceutical companies filed a complaint against the government’s decision to reduce coverage on choline alfoscerate drugs. Choline alfoscerate drugs in Korea On July 8, 66 pharmaceutical companies with choline alfoscerate issued a joint statement about their complaint filed for Korea’s Health Insurance Review and Assessment Service (HIRA) to reassess the reimbursement adequacy. The companies reprimanded the decision contrasts against the government’s objective of adopting selective reimbursement system as the pharmaceutical expenditure among senior citizens would rise significantly, it does not properly reflect social demand on the drug, and they claimed the unreasonable decision goes against the order of executing clinical reevaluation first followed by reimbursement reevaluation. The 66 companies argued, “Steeply raising the patient copayment rate from 30 percent to 80 percent on some of choline alfoscerate’s indications (mild cognitive impairment and depression) completely contradicts the foundational goal of National Health Insurance coverage enhancement initiative that provides coverage on non-reimbursements (selective reimbursement system) to lower patient’s burden on medical expense and to improve medical accessibility.” The companies added, “While the global medical scene is still seeking for a proper dementia treatment, lowering the coverage rate on choline alfoscerate that delays the progression of dementia in order to save finance also contradicts the National Dementia Management Program.” The government's decision would leave no choice for the economically vulnerable senior citizens but to give up on using the drug. The companies also rebuked the decision does not properly reflect the social demands based on financial impact, medical importance, affected age group, and patient’s financial burden. To accommodate the social demand, the current special case in patient copayment imposes differentiated rate by categorizing depression as a mild case (copayment rate at 40 percent to 50 percent when prescribed in general hospital), and stroke as a severe disease (copayment rate at 5 percent). However the pharmaceutical companies states the new reevaluation on choline alfoscerate has fixed the copayment rate at 80 percent for all three indications—emotional and behavioral change, senile pseudo-depression, and secondary symptoms induced by mild cognitive impairment and stroke with risk of progressing into dementia. They also complained the order of reimbursement reevaluation was shuffled. The companies criticized, “Generally, drugs undergo reimbursement listing procedure after receiving an item approval, but choline alfoscerate had its reimbursement feasibility evaluation before re-verifying the safety and efficacy of the drug,” and “as a result, the affected pharmaceutical companies’ motivation to conduct the clinical reevaluation on choline alfoscerate has greatly diminished.” The 66 companies urged, “Choline alfoscerate has been prescribed for over two decades in Korea, and even the clinicians stress the reimbursement should be reevaluated based on the Ministry of Food and Drug Safety’s (MFDS) approval details.” On June 11, HIRA has decided to grant selective reimbursement on choline alfoscerate after reevaluating the drug’s reimbursement feasibility. A patient diagnosed with dementia taking choline alfoscerate drug to improve symptoms like cognitive impairment would maintain the copayment rate of 30 percent. But patient prescribed with the drug without the diagnosis would pay 80 percent of the pharmaceutical expense as copayment.
- Policy
- Safety verification data should be submitted for Metformin
- by Lee, Tak-Sun Jul 10, 2020 06:13am
- When applying for the approval of Metformin, a diabetes treatment drug for which carcinogenic substance NDMA has been detected, additional safety verification data should be submitted in the future. In particular, data that can prove that NDMA is not generated during the process should also be attached. According to the industry on the 8th, the Convergence Innovation Product Support Group of the MFDS recently prepared a 'Metformin Raw Material and Containment Authorization Management Plan', and provided information through associations. On May 26, the MFDS discontinued and recovered 31 items of Metformin in which NDMA, a carcinogenic substance, was detected excessively. It was instructed to submit process verification data demonstrating that NDMA is managed below the standard in the manufacturing process of the drug product by August 31st. The management plan prepared this time is about the permission, notification and registration (change) of raw materials and containing agents. According to the management plan, if new raw materials and containing agents are managed under NDMA management (maximum allowance of 96 ng per day), permission, notification and registration are processed. In addition, it is planned to check the evidence only for quality-related changes (raw drug and its quantity, manufacturing method, manufacturer, storage method, and usage period). Safety data includes 'process verification data' that can prove that NDMA is not generated during the process, and 'stability data' that has undergone long-term preservation tests. Specifically, the process verification data includes process variables that may affect NDMA production, NDMA generation potential review data due to the effect between Metformin and other components, storage conditions tests, and packaging and container reviews, In the future, NDMA occurrence in the manufacturing process or preventive/corrective measures that can be adjusted within the maximum allowable capacity per day, and NDMA detection variability between manufacturing lot numbers are considered. It also includes considerations for NDMA test results and test method validation data (when using its own test method), manufacturing process, process inspection, and standards. The stability data is based on the new drug, and the period of use is set by the long-term preservation test, but the period of use is set within 24 months based on the long-term preservation test for 12 months, the accelerated test for 6 months. NDMA detection list is added to the stability test, and in the case of the test method, validation data is exempted when using the test method by domestic and foreign regulatory agencies such as the MFDS. However, at least one actual production batch data should be submitted when selecting a stability test lot. The MFDS plans to supplement and submit safety proof data in connection with the process of complaint handling in the case of permits, reports, and changes to Metformin.
- Policy
- Government asks Gilead to import Remdesivir for 5,360 people
- by Lee, Jeong-Hwan Jul 10, 2020 06:13am
- While COVID-19 Pandemic was prolonged, it was found that the government limited the amount of Remdesivir, which was known to be effective in COVID-19 treatment, to 5,360 servings. The Central Disease Control Headquarters requested an emergency import of Remdesivir for 360 people and the pandemic preparation for 5,000 people. Kang Giyun, a member of United Future Party said on the 8th, "As a result of confirming the private internal documents of the KCDC, only requested the import of Remdesibir for 5,360 people." An antiviral drug, Remdesibir, was approved by the US FDA on May 1st for emergency use following the announcement that the recovery period for COVID-19 inpatients has been reduced by 31%. Currently, the United States has announced plans to secure 92% of Gilead's production of Remdesibir by the end of September. It means that countries around the world have jumped into the battle to secure the quantity of Remdesibir, and the competition has become fierce. Provided by Kang Ki-yoon In this situation, the KCDC asked Gilead Korea on the 3rd of last month to import Remdesibir for 5,360 people. According to data released by Kang Giyun, the KCDC officially sent Gilead a request of Remdesivir for urgent use (for 360 people) and the pandemic (for 5,000 people). Earlier, the KCDC received a portion of the free supply from Gilead in July and supplied Remdesivir to 29 domestic patients as of July 6th. Some of the quantities supplied by the KCDC in July have not been revealed, and the company plans to continue to purchase Remdesivir through price negotiations with the goal of importing 5,360 people from August. A member Kang said that the U.S. government is swearing that all Americans will get treatment whenever they want, and it is not possible to specify when the pandemic will end and when a domestic outbreak will occur. Also he added that it is necessary to properly check whether the amount of 5,360 servings is appropriate in terms of scale and secure sufficient treatment.
- Company
- No obligation to notify the originals of the split strategy
- by Kim, Jin-Gu Jul 09, 2020 06:27am
- In the patent dispute of Galvus (Vildagliptin),” a diabetes treatment for DPP-4 inhibitors that was recently completed, a blind spot in the licensed patent linkage system occurred. Generic company did not “notify” the original company of the fact that they applied for an item license in the process of challenging patents with a so-called “split indication” strategy. The original company claimed that it was in violation of the Pharmaceutical Affairs Law and the item license was invalid. In response, the MFDS, "It is not considered a violation of the Pharmaceutical Affairs Law." If there is another attempt to overcome the patent with the indication splitting strategy, it is still necessary to decide whether to notify according to the current regulations. ◆Controversy over the violation of the Pharmaceutical Affairs Law in the process of Hanmi's Galvus' patent dispute GalvusHanmi voluntarily withdrew its approval for Vildagle 50mg, generic for Galvus on the 6th. As a result, the patent dispute over Galvus was ended. 'Split indication', which received attention as a new patent overcoming strategy, lost its power. The controversy over the “violation of the Pharmaceutical Affairs Law” was raised in this dispute. The original company, Novartis, filed a claim that Hanmi was violating the Pharmaceutical Affairs Law because it did not notify them of the application for an item license in the process of challenging the patent. According to the licensed patent linkage system stipulated in he Pharmaceutical Affairs Law and the Patent Law, the generic company must notify the patent holder of the application for permission within 20 days from the filing date when applying for a license for a drug listed on the patent list. Hanmi Pharm said there was nothing wrong with it. It was argued that there was no obligation to notify, as the application for an item license was made to the extent that the patent rights were ineffective. Hanmi applied without excluding one of the five Galvus indications. It is a narrow interpretation of the effect of patent rights applied to Galvus. The reason was that Galvus patent is limited to 3 out of 1 to 5 indications. The MFDS has accepted the application. In January of this year, Vildagle was licensed. In April, insurance benefits were also registered. However, Hanmi did not release the product due to ongoing patent disputes. ◆How is the notification obligation required for registration? Novartis filed a lawsuit against the MFDS to revoke the license. It was alleged that the permission of the MFDS was also invalid, because the notice obligations prescribed by the licensed patent linkage system were not observed. As a result, the dispute ended with happening because Hanmi lost the patent trial and voluntarily withdrew the item license from Vildagle. If another generic company challenges the patent with a splitting strategy, it is unclear whether or not the original company should be notified of the application for an item license.. ◆The MFDS, "It is difficult to understand it as a violation of the Pharmaceutical Affairs Law" The MFDS said that there would be no problem without notifying the original company. An official from the MFDS said, “There is no change. It is not a violation of the Pharmaceutical Affairs Law if the scope of the application for item licensing is not related to the extended patent content." "It is legally dependent on what the permission is," he said. "It can be interpreted based on the contents of the extension of the patent office.” However, he said, “The patent judge interpreted the scope of the patent right as specified in Article 95 of the Patent Act as a trial decision. As Hanmi failed to avoid Galvus patents (with a splitting strategy), it is highly unlikely that other pharmaceutical companies will pursue the same strategy.”
- Company
- Amgen won the second trial of 'Enbrel' patent
- by Kim, Jin-Gu Jul 09, 2020 06:26am
- Samsung Bioepis, Benepali in Europe, and Eticovo in US Samsung Bioepis' Enbrel biosimilar 'Eticovo' (Etanercept) is expected to postpone the US debut. A patent lawsuit was conducted that could affect the Eticovo's early launch strategy, but the US court sided with the original company. According to the pharmaceutical industry on the 6th, the U.S. Federal Court of Appeals earlier this month has sided with the original company in a patent lawsuit between Enbrel's patentee, Immunex and biosimilar maker Sandoz. Immunex is a subsidiary of Amgen. This is the same result as the first trial made by the New Jersey District Court. The court respected the original trial that Sandoz company's failure to provide sufficient grounds to prove Amgen's patent invalidity. As a result, Amgen succeeded in maintaining and defending Enbrel's patent until 2029. However, the possibility of reversal remains. Immediately after the second trial was announced, Sandoz announced its intention to appeal the third trial. The reason that Sandoz and Amgen's litigation has attracted attention is that this ruling also affects Samsung Bioepis' Eticovo. Sandoz and Samsung Bioepis are actually in a patent dispute with Amgen. Enbrel biosimilar ‘Erelzi’ by Sandoz was approved by the U.S. Food and Drug Administration (FDA) in 2016. Eticovo by Samsung Bioepis was approved in April 2019. However, the two companies are unable to release products to the US market. They have the challenge of overcoming Amgen's patent. It is analyzed that Eticovo’s case is likely to follow the results of Erelzi’s case. It means that it is also determined whether Eticovo will be launched early according to the results of the patent lawsuit between Sandoz and Amgen, which will be judged by the US Supreme Court. Samsung Bioepis is actually watching the lawsuits between Sandoz and Amgen. It is said that there is no full-scale pleading after the lawsuit under the licensed patent linkage system began in April of last year. An official from Samsung Bioepis said, "We are watching the results of the lawsuit between Sandoz and Amgen." Samsung Bioepis currently has four biosimilars in the United States. Eticovo, Remicade biosimilar 'Renflexis', Humira biosimilar 'Hadlima', and Herceptin biosimilar 'Ontruzant', etc. Of these, Renflexis and Ontruzant are currently on sale. Eticovo & Hadlima have been postponed due to patent. However, Hadlima can be released after 2023 according to an agreement with the original company, AbbVie.
