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- 2026-04-13 04:34:39
- Company
- ₩150 bil export of Celltrion’s Regkirona on track to
- by Kim, Jin-Gu Dec 10, 2021 05:51am
- Export of Celltrion’s COVID-19 antibody treatment ‘Regkirona (regdanvimab)’ is now fully on track. On the 9th, Celltrion Healthcare announced that it had completed shipping 150,000 vials of the initial load of Regkirona for 9 countries in Europe. Celltrion Healthcare has been discussing exporting Regkirona with 70 countries. In addition to the 9 countries that the company is supplying its initial load to, the company has signed supply agreements with a total of 18 countries. The total amount that has been and will be supplied in December alone is expected to reach ₩150 billion. Demand for the supply of Regkirona has been increasing due to the increased product reliability following the European Commission's (EC) marketing approval and the rapid increase in the number of confirmed COVID-19 cases. Celltrion Healthcare plans to supply the maximum amount this year through close cooperation with Celltrion, which is in charge of production. Regkirona received official marketing authorization in Korea and Europe. Also, the drug received conditional approval or emergency use authorization in other countries including Australia, Indonesia, Brazil, and Peru. Celltrion Healthcare said that the company is expanding discussions to sign new agreements with these countries. As a result, the industry experts expect the company to supply more Regkirona next year compared to this year. An official from Celltrion Healthcare said, “With additional approvals continuing around the world following the EC approval, we plan to continue to increase making supply agreements. In addition to Regkirona, the Celltrion group will continue to contribute to overcoming the global COVID-19 pandemic by developing innovative solutions such as CT-P63 to tackle new variants and inhalable forms of treatment.
- Policy
- The method of writing for HBP combination is improved
- by Lee, Tak-Sun Dec 10, 2021 05:51am
- The method of writing permission for HBP and dyslipidemia combinations is improved more efficiently. Previously, information on individual ingredients was simply listed, but in the future, it will be prepared based on a comprehensive evaluation of combinations. According to the pharmaceutical industry on the 6th, the MFDS prepared a plan to improve the method of writing permission for high blood pressure and dyslipidemia combination drugs and guided them through pharmaceutical organizations. According to the improvement plan, the efficacy of the high blood pressure and dyslipidemia combination will be described in consideration of the purpose of administration, clinical trial results, and primary and secondary therapy. In particular, precautions related to the treatment of individual ingredients for dyslipidemia should not be described. However, in the case of a composite containing Ezetimibe, the matters related to diet, administered drugs, and lipid tests described in the "effect" can be stated in the "Precautions for Use." The precautions for use include prohibition of administration of each main ingredient, careful administration, and general caution related to administration as a complex agent. As for the adverse reaction, the contents of the clinical trial conducted as a composite agent may be first described, and then the adverse reaction may be additionally described as a single agent. However, adverse reactions of unlicensed ingredients can be omitted. For example, in the case of the fourth composite, the adverse reactions of the second to third composite agents should not be described. As the existing permission for high blood pressure and dyslipidemia complex drugs lists information on individual components, it is difficult for the general public to recognize the product characteristics of the combination drugs, and only the attached documents are prolonged. In this improvement plan, the MFDS said, "The permission for complex drugs should provide information so that experts and patients can use the drug safely and effectively." The MFDS explained, "It should be mainly prepared based on information obtained from combination or combined administration, and information obtained when individual ingredients are administered alone can be additionally presented if appropriate." An official from the MFDS said, "There was an opinion that it was difficult to read the existing description method because it lists individual ingredients." The MFDS distributed a revision to the "Guidelines for Clinical Trial of Combination Drugs" along with this improvement plan to guide efficacy, effectiveness, and approval of primary therapy. According to the guidelines, if an unlicensed single agent is developed as a combination agent, in principle, it is possible to obtain permission only for the efficacy of the combination drug through clinical trials (therapeutic confirmation clinical trials, etc.). In order to be approved as a primary therapy, the feasibility of development as a primary therapy must first be proven in consideration of the mechanism of action of individual main components of the complex and clinically recommended treatments. In particular, it is possible when a therapeutic confirmation clinical trial is conducted on patients who need to administer complex drugs from the beginning to reach the target treatment effect, and safety and effectiveness are proven.
- Company
- Signifor Lar discontinued in the lacking acromegaly Tx mkt
- by Eo, Yun-Ho Dec 09, 2021 05:59am
- A considerable blow is expected in the already lacking acromegaly treatment market with the discontinuation of one of its very few available options. According to industry sources, the domestic supply of the acromegaly treatment ‘Signifor LAR (pasireotide)’ has been discontinued. The decision was made as Novartis sold the rights to Signifor La to Recordati SpA.,an Italian pharmaceutical company. As a result, the drug that had been developed by Novartis and distributed by Samoh Pharm will now be discontinued in Korea. However, the problem lies in the patients. Signifor LAR is a second-line treatment for acromegaly that was listed for reimbursement in November 2017. At the time, Signifor LAR was the only second-line treatment option available in the market. However, Pfizer’s ‘Somavert (pegvisomant)’ was listed in September, adding one more option as a second-line treatment. The discontinuation in its supply would most greatly affect those who are currently receiving Signifor LAR. As a rare disease treatment, around 10 patients in Korea have been using Signifor LAR, but they may experience insurance cuts if they switch to Somavert due to unclear reimbursement standards. And the patients cannot return to the drugs that they had used for first-line treatment after already failing treatment with the same drugs. Also, there are only two options available in the first-line – Ipsen’s ‘Somatuline Autogel (lanreotide acetate)’ and Novartis’ ‘Sandostatin LAR (octreotide).’ Acromegaly is a rare disease in which the pituitary tumor causes hypersecretion of growth hormones to result in facial deformation and hypertrophy of the hands and feet. The key treatment objective for acromegaly is to reduce the level of growth hormones and insulin-like growth factor-1 (IGF-1) secretion. However, 45% of the patients who were treated with first-generation somatostatin analog (SSA) were unable to achieve biochemical control. Meanwhile, in a Phase III trial that compared Signifor LAR with a maximum dose first-generation SSA, Signifor LAR demonstrated superiority in ▲ Biochemical control (mean GH level under 2.5㎍/L and normal range IGF-1 level) ▲GH and IGF-1 control ▲decrease n tumor size Patients whose acromegaly was not adequately controlled after being treated for over 6 months existing SSA (octreotide 30mg or lanreotide 120mg) participated in the trial and were randomly assigned to Signifor LAR 40mg, 60mg, or first-generation SSA for treatment. Study results showed that the proportion of patients that met the primary endpoint of biochemical control at 24 weeks was 15% for the Signifor LAR 40mg group and 20% for the Signifor LAR 60mg group, which was higher than that of the control group (0%).
- Policy
- The ruling party shouted to review the Judiciary Committee
- by Lee, Jeong-Hwan Dec 09, 2021 05:58am
- Democratic Party of KoreaThe ruling party members of the Health and Welfare Committee issued a statement and strongly protested when the revision to the National Health Insurance Act, which included strict regulations on doctor licenses, and the bill to return and refund drug prices, were put on hold at the stage of the Legislation and Judiciary Committee. Members of the Democratic Party of Korea and of the Welfare Committee, urged the bill to be immediately proposed, saying that the leak of national health insurance finances is intensifying due to the brakes of the agenda of the Legislation and Judiciary Committee. On the 7th, the ruling party's welfare committee members adopted and published a statement. The ruling party's welfare committee members asked the People Power Party to withdraw its opposition to the revision of the Health Insurance Act and immediately cooperate with the Legislation and Judiciary Committee on the agenda.This is the second time that ruling party members have issued a statement after the bill on health medicine has been canceled. Earlier on February 26 this year, the ruling party's welfare committee held a press conference and issued a statement after the revision to the medical law, including the cancellation of a serious crime doctor's license, failed to be reviewed during the extraordinary National Assembly in February. In addition, the Democratic Party of Korea's welfare committee criticized the People Power Party for blocking the review of the revision to the Health Insurance Act. Democratic welfare committee members say that despite the administrative litigation of pharmaceutical companies' suspension of execution over the past five years, the People Power Party has prevented the bill from being proposed only with opposition from some pharmaceutical companies. In addition, members of the Democratic Party of Korea pointed out that the Health Insurance Act also included a bill to recover all unfair profits from illegal health insurance recipients such as illegal secretariat hospitals, and that the process was delayed due to opposition from the People Power Party. In addition, the Democratic Party of Korea's welfare committee members said, "An alternative to the Health Insurance Act passed by the ruling and opposition parties at the plenary session of the Welfare Committee was not presented on the agenda of the Legislation and Judiciary Committee on December 8th." They pointed out, "People Power Party argues that the Moon Jae In government's strengthening of health insurance coverage is at stake, but opposes legislation that leaks health insurance finances due to indiscriminate overuse of lawsuits by pharmaceutical companies." He then said, "Alternatives to the Health Insurance Act also included provisions to block illegal supply and demand by collecting all unfair profits from illegal hospitals run by the office manager." They emphasized, "It is a betrayal of interest to leave the office manager's hospital, which gnaws away insurance finances, and insist on protecting health insurance premiums while leaving the health insurance leak intact due to indiscriminate administrative litigation by pharmaceutical companies."
- Opinion
- [Reporter's view] Improving guidelines excluding PVA
- by Lee, Hye-Kyung Dec 09, 2021 05:58am
- The NHIS announced the revision of Article 6 (1) and (2) of the Price-Volume Agreement (PVA) detailed operation guidelines for "Article 6 (Drugs Excluding Negotiations)." According to the policy, The NHIS guidelines will be implemented immediately after the revision is made, but this time, they will be applied from January 1 next year after inquiring opinions as opposition from the pharmaceutical industry is expected. The revision calls for expanding the "same product group with an annual claim of less than 1.5 billion won" to "less than 2 billion won" in Paragraph 1, Paragraph 2, "items with an upper limit of less than the arithmetic average of the main component code." The NHIS unveiled a plan to improve the PVA (excluding) system at the 10th public-private consultative body held on the 2nd. The reason is that PVA has been reserved for drugs with small insurance financial savings in consideration of the burden of the pharmaceutical industry and administrative costs required to conduct drug price negotiations, but guidelines have been improved due to various problems. When the health authorities made the guidelines in 2014, the standard for making the exclusion clause for PVA was a drug with a small effect on insurance financial savings. While operating PVA for 7 years and 4 months, drugs with a large effect of reducing insurance finances were often excluded from negotiations for reasons below the arithmetic average, or they voluntarily cut drug prices to avoid PVA. These drugs included blockbuster drugs with an annual claim of more than 80 billion won, which went against the PVA system. As a result of the NHIS' analysis of drugs that have avoided PVA negotiations with voluntary cuts within the past two years, a total of 39 drugs have been cut by 1 won, and some of them have exceeded the arithmetic average price. If the NHIS suddenly lowers its arithmetic average exclusion standard from 100% to 90%, the pharmaceutical industry will face a backlash. The NHIS said it has set the PVA negotiations to be omitted if it accepts a 10% drop in drug prices according to the "weighted average of alternative drugs 90%" of the new drug negotiations criteria. Like new drugs, it means to voluntarily cut 10% of the usage, or otherwise proceed with the NHIS and PVA. PVA will be able to proceed smoothly if it is a pharmaceutical company that makes a trick at the arithmetic average price, but it is also understandable that the pharmaceutical industry will protest if the arithmetic average price is reduced by 1%. There is no reason for the pharmaceutical industry to oppose the expansion of claims for the same product group under paragraph (1) 1. If the NHIS' simulation results raise the billing amount from 1.5 billion won to 2 billion won, 23 out of 59 items under the same regulation that completed PVA negotiations this year will be excluded from the list. The NHIS will receive opinions from the pharmaceutical industry on the PVA guidelines containing such information. KPBMA, KRPIA, and KOBIA, which have already participated in public-private consultations, have opposed the revision of the guidelines. There are two main contents of this amendment. The pharmaceutical industry may want only the criteria for expanding the amount of claims to be reflected and the criteria for reducing the arithmetic average to be not reflected. However, the NHIS may not be meaningful in improving the PVA guidelines with just one thing. The association's opinion is important during the opinion inquiry period, but it is also important to reflect the opinions of individual pharmaceutical companies according to their size. This is why it is important for pharmaceutical companies to express their opinions on improving PVA guidelines during this period.
- Policy
- 6 cases of Ultomiris & 1 case of Spinraza were pre-approved
- by Lee, Hye-Kyung Dec 09, 2021 05:58am
- Benefits for pre-approval of six new PNH patients for Ultomiris administration were approved and four cases were rejected. There were no applications for new salary administration for Soliris, but two applications for pre-approval for new aHUS patients were not accepted. In the case of Spinraza, a treatment for Spinal Muscular Atrophy (SMA), one application for new patient benefits and two data supplementations were decided. Of the 25 monitoring reports, 23 were approved and 2 were disapproved. The HIRA conducted deliberation on six items, including Soliris and Ultomiris, and whether hospitalization fees were recognized. According to the results of the deliberation on the 2nd, Soliris decided to approve 33 PNH monitoring applications, to disapprove 2 new aHUS cases, to disapprove 1 retrial, to approve 2 monitoring cases, and to disapprove 1 case. Ultomiris has approved 6 out of 10 new patient approval applications for PNH, 4 disapproval, 3 re-deliberation, and 1 monitoring approval. Soliris is 5,132,364 won per vial (30 ml), and if three vials are administered every other week, the drug price per year alone is 400 million won. Ultomiris was listed at 5,598,942 won per bottle on June 7, and should be administered once every eight weeks after the initial dose per patient is administered. Soliris and Ultomiris are ultra-high-priced new drugs, so they implement a pre-approval system to determine whether they are eligible for medical care benefits, and the agency must administer Soliris or Ultomiris within 60 days from the date of notification of the results of the deliberation. If it is intended to be administered after 60 days, it must be re-applied. In one case, data supplementation was requested, and in the other case, data supplementation was required as it was necessary to confirm whether the patient could receive spinal canal injection stably due to the long course of the disease. Spinraza is an ultra-high-priced new drug of 92.35 million won per bottle of 5ml, and medical institutions that want to take it must apply for pre-approval and submit a monitoring report every four months after approval of salary. Details of the deliberation can be found in the case of www.hira.or.kr or biz.hira.or.kr > Comprehensive Review Standards Service> Criteria> Review Standards> Public Deliberation.
- Policy
- Patients fume over non-deliberation of Kymriah·Keytruda
- by Lee, Jeong-Hwan Dec 09, 2021 05:58am
- Patients have set out to demand PBAC's prompt deliberation of the new reimbursement listing for Novartis Korea’s cancer immunotherapy Kymriah in acute lymphoblastic leukemia and diffuse large B-cell lymphoma and reimbursement expansion for MSD Korea’s non-small cell lung cancer treatment Keytruda to first-line in NSCLC. The patients expressed strong regrets after it was found that the agenda related to the reimbursement of Kymriah and Keytruda was not put up for deliberation by the Pharmaceutical Benefit Assessment Committee on the 2nd, the last meeting set for this year. On the 1st, the Korea Alliance of Patient Organizations (KAPO) said, “The non-deliberation of the agenda at the PBAC meeting reduces the will to fight the disease and threatens the lives of leukemia, lymphoma, and NSCLC patients in Korea." Novartis had applied for the reimbursement of its leukemia and lymphoma treatment, the CART-T therapy Kymriah, on March 3rd this year through the ‘approval-reimbursement review linkage system,’ and received a conditional nod from the Cancer Disease Deliberation Committee deliberation 7 months later on October 13th. Keytruda, which was listed for reimbursement as a second-line treatment, applied to extend its reimbursement to first-line monotherapy in NSCLC in September 2017 but failed 9 times. After 4 years and numerous attempts, the agenda had finally received a conditional nod at the CDDC meeting on July 14th, 2021. The life expectancy of recurrent·refractory leukemia and lymphoma patients that need treatment with Kymriah is only 3 to 6 months. In other words, patients who cannot bear the non-reimbursed 460 million won cost of the drug are dying waiting for the reimbursement listing. Also, Stage 4 NSCLC patients had borne the 70 million to 100 million won drug cost of Keytruda for the past 4 years to receive treatment or received partial support with their indemnity medical insurance or MSD's non-reimbursement drug cost support program. Others received treatments from hospitals that have been pilot operating the new DRG system or received treatment with another anticancer drug then used Keytruda as second-line with disease progression. KAPO said, “Deliberations on Kymriah and Keytruda have barely passed the CDDC on condition and are being delayed, but this is not due to the clinical efficacy of the drugs. Kymriah and Keytruda are representative drugs that are directly related to life, and there is little controversy about their therapeutic effect. It is just that the drugs’ prices are very expensive and patients so many. The concern over the increased burden on NHI finances, the drug price, and fiscal concerns are what has been delaying the listing of these drugs.” The patient organization stressed that the access to treatments that are directly related to life should not be obstructed due to administrative procedures for reimbursement listing. It said, “Patients who meet the MFDS indication can even now receive non-reimbursed treatment with Kymriah or Keytruda. The harsh reality is that the late-stage patient’s life or death, and extension of life depends on their economic ability, on whether they have the ability to pay for the high priced non-reimbursement cost for their treatments. For new drugs directly related to life such as Kymriah and Keytruda, the government should spend NHI finances to save the patients’ lives first, then decide on how to list and set their drug price through formal procedures as they are doing now.” Currently, no system in Korea allows for the priority use of NHI finances even if the new drugs are directly related to life. Therefore, KAPO demanded that the government and the National Assembly introduce a constitutionally guaranteed 'rapid NHI listing system for new drugs directly related to life'. The organization also plans to propose the introduction of this system as a presidential campaign to presidential candidates. It added, "Pharmaceutical companies develop and market new drugs to save the lives of patients. Also, the nation operates a NHI system to ensure that no citizen is left untreated due to reasons of cost if there are drugs available. To fulfill this objective, we need to quickly complete Kymriah’s reimbursement listing process that has been ongoing for 9 months and Keytruda’s first-line reimbursement that is being discussed for over 4 years.”
- Policy
- Impurity detected Cozaar is excluded from recovery
- by Lee, Tak-Sun Dec 08, 2021 06:01am
- In the case of a single drug in Losartan formulation where impurities were detected, it is interpreted that only the original drug was excluded from recovery, exposing the risk of domestic generics again. It is analyzed that the reason why the original drug was excluded from the collection list is because the raw material process is different. The MFDS announced on the 7th that it will recover 295 items (98 companies) of Losartan drugs that have been excessively detected with Azido-based impurities. The majority of the 306 (99 companies) items in circulation are included. As impurities were confirmed to be within the daily intake allowance, 11 items were excluded from the collection, 5 items from foreign pharmaceutical companies and 6 domestic pharmaceutical companies. In particular, in the case of Losartan potasium, only "Cozaar" and "Cozaar 100mg" of Organon, Korea were excluded from the recovery list. All of the remaining identical generic drugs were included in the recovery list. An official from the MFDS explained, "We estimate that this impurity was caused by unintended residue from the use of Azide during the raw material process," adding, "However, we know that the original did not use Azide." However, the official explained that there are products that are currently shipped below the standard by improving the raw material synthesis process for generic drugs. The original and generic materials are the same ingredients, but there was a difference in the synthesis process. Finished drugs were included in the collection list one after another due to consignment. There are 16 factories in Korea that produce Losartan single 5-mg finished products. These 16 places are connected by consignment and consignment structures supplied to 88 pharmaceutical companies. As a result, if a problem occurs in one finished product factory, products from various companies will also be recovered. This consignment structure has also been problematic in the Valsartan formulation, where the NDMA impurity crisis first occurred. Accordingly, the government has been implementing a policy since last year to discriminate against generic items entrusted with biological equivalence tests for consignment production when registering drug prices. In addition, from July this year, a revision to the Pharmaceutical Affairs Act was implemented to require one trustee to supply products to only three consignment companies to restrict consignment production through sharing of biological equivalence tests. As a result, it can be seen that the Losartan impurity incident also showed generic risks. However, experts say that it is dangerous to interpret that there is a difference in quality between the original and generic in that the generic raw material process was initially approved by the MFDS.
- Policy
- No recall crisis expected to arise from losartan impurities
- by Lee, Tak-Sun Dec 08, 2021 06:00am
- Although 295 antihypertensive treatments that were found with impurities were ordered recalled, due to the low risk and specificity of the targeted items, no disruption is expected from the exchange, re-prescriptions, or re-dispensing of such drugs. The Ministry of Food and Drug Safety announced on the 7th that 295 losartan items that were found to contain azido impurities that exceed the allowed daily intake of 1.5㎍/day (1.7~88.7㎍/day) will be recalled. However, the ministry emphasized that the risk of its harm to the human body is very low and that the patients should not discontinue taking the drugs. The azido impurities that were detected this time occur specifically in the losartan ingredient, and although the properties of genetic mutations have been confirmed in the ingredient carcinogenicity has not been yet identified. In particular, an assessment of its health effect on the majority of patients who took losartan that had an excess amount of impurities than the allowed daily intake showed that the added risk of cancer from the impurities was 0.54 out of 100,000, which was a very low and negligible level. An MFDS official said, “The evaluation was based on the representative value (median value) that was set with losartan drugs that had impurities exceeding the amount allowed for daily intake. We also took into account the possibility that the drugs that had a higher amount of impurities will be taken for life (70 years).” As a result, the MFDS emphasized that even if one takes losartan drugs that contain an excess amount of impurities, it has little effect on one’s health, and that patients who were prescribed the product should not arbitrarily discontinue taking the drugs. However, the exchange, re-prescriptions, or re-dispensing measures were prepared to resolve anxiety for patients with health concerns. The exchange, re-prescriptions, or re-dispensing of the drugs can be done at no out-of-pocket cost on the patient’s part. However still, the number of re-prescriptions or re-dispensing is not expected to be high. Although all lot numbers of 241 items will be fully recalled, only some lot numbers of 54 items and none from 11 items are recalled, and identifying the drugs that are subject to recall is also a complicated process. Also, some of the items for which full recalls are being conducted for all lot numbers, some are being re-released as normal items, and may only be exchanged at hospitals rather than be re-prescribed or re-dispensed at hospitals. In fact, only 4 cases of consumer exchanges arose for sartan drugs that were recalled due to excess impurities in September. Due to this, there had been some criticism that the authorities had wasted too much time on the consumer exchange process that did not have many actual cases, delaying the recall period for the harmful drugs in business.
- Company
- Hanmi’s poziotinib enters final phase for commercialization
- by Kim, Jin-Gu Dec 08, 2021 06:00am
- ‘Poziotinib,’ a drug licensed out by Hanmi Pharmaceuticals, is entering its last phase for authorization in the US. The variables that remain to approval are the US FDA’s interpretation of the clinical trial results and the on-site investigations on the company’s production and manufacturing facilities. If these progress as planned, Hanmi Pharmaceuticals will be able to achieve its first global commercialization landmark with the new drug technology export earlier next year. On the 6th (local time), the US company Spectrum Pharmaceuticals submitted a new drug application (NDA) for poziotinib. It is indicated for the treatment of locally advanced and metastatic HER2 Exon20 mutant-positive non-small cell lung cancer (NSCLC) in patients who have previous treatment experience. Poziotinib received the fast-track designation in March from the FDA. Drugs that receive the fast-track designation receive various support from the FDA in the stages of its development. Also, when applying for marketing authorization, the drugs are allowed to submit data sequentially under a rolling review as soon as data is available and are allowed to be discussed for priority review, etc. In particular, the priority review would shorten the FDA's marketing authorization review period from 10 months to 6 months. Considering the circumstances, Spectrum expects poziotinib to be approved in the US by the first half of next year. If poziotinib receives FDA approval, it would be a first for Hanmi to succeed in the global commercialization of a new drug that it had exported technology for. The variables that remain to approval now are poziotinib’s clinical trial data and on-site investigation. Spectrum submitted the NDA based on the cohort 2 results of the ‘ZENITH20’ clinical trial. Trial results showed that the objective response rate (ORR) of patients with HER2 Exon20 mutant-positive non-small cell lung cancer (NSCLC) with treatment experience was 27.8%, the median duration of response (mDOR) 5.1 months, and the median progression-free survival (PFS) 5.5 months. However, the drug showed somewhat less encouraging results in a clinical trial that was independently conducted in Europe. Professor Arsela Prelaj of the IRCCS National Cancer Institute Foundation in Italy compared data of 30 patients who were administered poziotinib to 28 that did not. No significant difference was found, with the overall survival (OS) of the poziotinib-treated group being 19.2 months compared to the 18.2 months in the control group. However, when matched by propensity score and calculated by Cox's proportional hazard regression model, the risk of death in patients who took ‘poziotinib’ was reduced by 34% at the most. Although no significant OS improvement was demonstrated in the study, the study still had meaning as it identified the possibility that the drug can reduce the risk of death. The results were announced at the ESMO virtual congress in September. The study was an investigator-led study without sponsorship from Hanmi or Spectrum. The other variable that remains is the on-site investigation. In the case of ‘Rolontis,’ another one of Hanmi’s technology export new drugs that Spectrum applied marketing authorization for, the on-site investigation had deferred what was on the brink of approval. The FDA determined that there were some problems with Hanmi’s factory in Pyeongtaek and sent a complete response letter (CRL) to Spectrum. Although Rolontis was expected to be approved in October last year, the FDA’s CRL has pushed back the schedule by over a year. Hanmi believes such an issue will not arise for poziotinib because the two drugs have different manufacturing facilities. An official from Hanmi said, “Rolontis is manufactured at Hanmi’s Pyeongtaek plant, whereas poziotinib is manufactured in the US. Also, most of the FDA’s requests for supplementation have been now addressed.” Therefore, the industry’s eyes are focused on whether Hanmi will be able to overcome its two previous failures and succeed in its third attempt. The FDA had deferred approval of Hanmi’s two technology export new drugs ‘Oraxol’ and ‘Rolontis’ in March and August this year. The company had licensed out the technology for its metastatic breast cancer drug Oraxol to Athenex but the FDA deferred its approval due to neutropenia concerns.
