- by Lee, Tak-Sun May 17, 2021 05:53am
The process for the rollout of Moderna COVID-19 vaccine in the first half of this year is gaining momentum. As the possibility obtaining marketing authorization for the imported vaccines on Friday(21st) is high, its rollout in the first half of the year is promising due to the Korea-US Summit event. In addition, the overall inspection of the distribution channels that were conducted prior to the introduction of the vaccine, including the simulation vaccine delivery training and safety inspection of GC Pharma’s logistics center in Ochang, have added strength to the possibility of Moderna’s vaccine being introduced in the first half of this year
On April 12th, GC Pharma had submitted an application for the approval of Moderna’s COVID-19 vaccine. On May 13th, the Central Pharmaceutical Affairs Council (CPAC) concluded that it was reasonable to grant approval of Moderna’s vaccine for use in adults 18 years or older as a two-dose schedule.
CPAC is a legal advisory board of the Ministry of Food and Drug Safety (MFDS), and the ministry is known to generally follow CPAC’s recommendations. However, in the case of COVID-19 treatments and vaccines, the MFDS receives three separate independent evaluations before granting final approval. The last expert meeting, by the ‘Final inspection Committee,' is scheduled to be held on the 21st next month.
Considering that the Final Inspection Committee followed CPAC’s decision for AstraZeneca, Pfizer, and Janssen COVID-19 vaccines as well as Celltrion’s COVID-19 treatment, unless a major issue comes up, the Moderna vaccine is also likely to be granted approval. The MFDS will hold a meeting with the Final Inspection Committee to finalize the labeling details and decide whether to approve the marketing authorization of the vaccine.
As the Korea-U.S Summit is scheduled on the same day, industry officials predict that the government will use the summit as an opportunity to approve the Moderna vaccine and announce its rollout schedule in Korea. Also, there have been media reports that 50,000 doses of the vaccine will arrive in Korea in the last week of May.
If the vaccine is imported this month, the government’s announcement of releasing the vaccine in Korea in the 2nd half of this year will come true. In the case of the Moderna vaccine, as the company prioritized its U.S. supply, the rollout schedules in other countries were expected to be delayed by one quarter. This was why there had been strong expectations that the vaccine will be introduced in the third quarter rather than the second quarter.
However, the mock delivery training for Moderna vaccines and the joint safety inspection conducted at GC Pharma’s logistics center in Ochang have supported the possibility that the introduction of the Moderna vaccine may be more imminent in Korea. In the case of these imported Moderna vaccines, the drug substance of the Moderna vaccine was first produced at the Lonza plant in Switzerland, then filled and finished by a Spanish pharmaceutical company. After its arrival in Korea, GC Pharma will take over its distribution as the license holder.
Apart from the imported vaccines, the CMO deal for producing the Moderna vaccine in Korea is expected to be announced during the Korea-U.S. Summit period. The popular prospect is that Samsung Biologics will be the CMO that fills and finishes the solution in Korea.
On such expectations, Samsung Biologics had publicly stated that “nothing has been finalized.” However, considering that the company drew a firm line on the rumors of a CMO deal for the Pfizer vaccine stating that “it is not true,” the rather unclear position of Samsung Biologics has added fuel to the rumor. Also, as John Rim, the CEO of Samsung Biologics will be at the South Korea-U.S. Summit, this also had added strength on the possibility of the company being the CMO for Moderna.
However, even after a CMO deal, it would take some time for the CMO to actually produce the vaccines, as pharmaceuticals manufactured in Korea are required to receive a separate approval from the MFDS. The vaccines that passed the CPAC review this month were imported vaccines, therefore a separate approval is required for domestically manufactured products. AstraZeneca had also submitted two applications for its vaccine; one for the manufacture and marketing authorization of its products manufactured by its CMO SK Bioscience, and the other for the import authorization of products manufactured outside of Korea, including those from Italy.
- [Reporter's View] It's up to pharmaceutical companies
- by An, Kyung-Jin May 17, 2021 05:53am
- Drug quality management is at stake. Over the past two months, four companies, including Binex, Vivozon, Chong Kun Dang and Hanall Biopharma, have been caught violating drug quality control. A total of 62 products are under administrative disposition due to violations of quality control by four companies. Including pharmaceutical companies in consignment contracts, the impact is even greater.
Thirty-four pharmaceutical companies that have entrusted production to four companies are also focusing to whether the MFDS will dispose of them further. A total of 38 companies are on the verge of being kicked out of the market because of the trustee's deviant behavior. The pharmaceutical industry fears it will spread to distrust of consignment generics. It is only a matter for some companies, and the consignment act itself should not be a problem.
In July 2018, the Valsartan crisis, which shook the global pharmaceutical market, was unprecedented in overseas countries as carcinogenic substance N-Nitrosodimethylamine (NDMA) was detected in Valsartan manufactured by China's Zhejiang Huahai.
NDMA was not originally subject to standard checks on Valsartan. Until Zhejiang Huahai reported that more NDMA was detected than the standard, no pharmaceutical company in the world cared about NDMA detection. The FDA and the EMA were not aware of the need for inspections, but rushed to investigate and come up with measures to determine the cause. It was just an unexpected accident. Chinese raw medicine and generic are starting to be blamed as if they were the causes of "low quality." It is also from this time that regulations on consignment generic have been tightened in Korea.
Health authorities set up a "Generic Drug System Improvement Council" and began to come up with measures to curb generic disorder. The MFDS has removed all deregulation granted to Entrusted generic. From next year, mandatory production of licensed products, which had been exempted from consignment generics, will be implemented again. It is also pushing to exclude consignment generics from generic exclusivity.
Following the reorganization of the drug price system, which took effect in July last year, the standard for calculating the drug price of consigned generic has also been lowered. The 53.55% upper limit price can be maintained compared to the original drug before the patent expires only when all requirements are met to conduct biological equivalence tests directly and use registered raw material drugs. The regulation on joint development of drugs under discussion at the National Assembly is also key to restricting the permission of consignment generic. Some amendments to the Pharmaceutical Affairs Law, which limits the number of drugs licensed in one clinical trial, passed the Health and Welfare Committee, leaving procedures for future plenary sessions, the Legislation and Judiciary Committee, and the plenary session.
The government's justification for tightening regulations on generic seems to be somewhat out of standard. The MFDS defines "generic" as a officially licensed drug based on the same quality as the original developed drug. It is not appropriate that the large number of generic drugs authorised by the Government is of low quality.
Nevertheless, pharmaceutical companies are largely to blame. If unreasonable regulations and misunderstandings are unfair, they should prevent repeated violations and come up with self-rescue measures to improve competitiveness in drug quality. The drug quality control agenda has already been controversial, although it was not originally due to generic. It is up to pharmaceutical companies to restore generic drug reputation.
- Off-label use of Olumiant and Botox denied
- by Lee, Hye-Kyung May 17, 2021 05:53am
- An application for the use ‘Olumiant(baricitinib) in patients with alopecia areata was rejected by the health authorities in Korea.
In addition, the application to administer Botox injections for the primary suture of facial lacerations and recurrent pancreatitis was also disapproved due to lack of medical evidence.
The Health Insurance Review and Assessment Service (HIRA) reviews applications in advance for the off-label use of drugs beyond the scope approved by the Ministry of Food and Drug Safety (MFDS) to prevent the use of medicines that lack medical evidence or have potential safety concerns.
According to the cases of off-label use disapprovals recently disclosed by HIRA, 8 cases of disapprovals including Olumiant and Botox were added this month, to make the cumulative number of disapproved cases to 209 in total.
In the case of Olumiant, a medical institution had applied to prescribe the 2mg or 4mg Olumiant tablet to a patient with alopecia areata for 12 months, but the application was turned down due to lack of medical evidence.
The application for the off-label use of Botox was for its use in patients who receive primary suture for facial lacerations and avulsions at emergency centers or outpatient clinics, and for patients with recurrent pancreatitis that have been excluded from all causes of acute pancreatitis such as gallstone, alcohol, hereditary, and autoimmune manifestations and is at high risk of pancreatitis due to ERCP procedures. The application was also denied approval.
Also, applications to administer ‘Carmine Injection 0.8%’ to women in the childbearing age who were diagnosed with infertility, or is suspected of infertility due to tubal factors (fallopian tubes, fallopian tube adhesions, paratubal cyst, fallopian tube plastic surgery subjects) to check the bilateral tubal patency of the fallopian tubes during laparoscopic surgery; and to administer ‘Antiroid tablet’ to patients in need of taste tests whose information on their PROP phenotype is deemed clinically useful, were also disapproved.
In addition, applications for the off-label use of 'Mabthera injection', 'Eglandin injection', and 'Valcyte 450mg' on RPGN patients, hospitalized patients after kidney transplant, and patients with glioblastoma without kidney failure, respectively, were rejected on the grounds of lacking medical evidence.
- 1+3 restrictions bill for generics & IMDs was passed
- by Lee, Jeong-Hwan May 17, 2021 05:53am
- The number of joint biological equivalence tests and joint clinical trials of generic and data IMDs is expected to be limited to three consignment companies per manufacturer. Only three additional medicines can be licensed for biological equivalence tests or clinical trials.
However, biological drugs such as high-tech new drugs and vaccines and medicines designated by the head of the MFDS may be exempted from regulations on "Common Biological Equivalence Testing and Clinical 1+3 Restriction."
On the 28th, the National Assembly's Health and Welfare Committee passed the 1+3 restrictions bill on drug co-development. The first bill subcommittee of the Welfare Committee voted to revise the bill of Seo Young-seok and Seo Jung-sook. Only three additional medicines can be licensed for biological equivalence tests or clinical trials.
The first bill subcommittee of the National Assembly's Health and Welfare Committee on the 28th passed some revisions to the Pharmaceutical Affairs Law proposed by Seo Young-seok and Seo Jung-sook, respectively, reflecting the MFDS' amendment.
The bill subcommittee's resolution will succeed in legislation if it passes the procedures of the Welfare Committee, the Legislation and Judiciary Committee and the plenary session. It was designed to establish a sound pharmaceutical industry by limiting the number of items in the pharmaceutical market.
In particular, recent GMP violations by the domestic companies such as Binex, Vivozon, and Chong Kun Dang have increased the feasibility of legislating regulations on generic and IMD regulations.
The MFDS, which had previously considered IMD regulations carefully, also expressed its support for regulations on IMDs after the GMP crisis, helping pass both bills.
Specifically, if the same manufacturing process is manufactured by the same manufacturer with the same manufacturing method as the pharmaceutical company's drug that directly conducted the BA test, the use of biological equality data will be limited to three times. In short, the number of consent to use biological equivalence test data for one drug is up to three items.
Clinical trial data can also be used for up to three items other than drugs from pharmaceutical companies. However, non-Rx drugs, biological preparations such as advanced biopharmaceuticals and vaccines, and other medicines determined by the head of the MFDS are not subject to the 1+3 restriction.
- Combination of Epidiolex & Clobazam are reimbursed
- by Lee, Hye-Kyung May 17, 2021 05:52am
- Starting this month, detailed standards for the health insurance application of "Epidiolex (Cannabidiol)," used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex, have been unveiled.
The HIRA recently released 'Question and Answer on Applying Benefit Standards to Epidiolex' and guided details on targets and methods of evaluation. Epidiolex was Emergency Use Medication by the MFDS for the use of "the treatment of Lennox-Gastaut syndrome and seizure related to Dravet syndrome" in patients over the age of two.
It was supplied to Korea through the Korea Organ & Essential Drug Center from April 1st.
Epidiolex can be reimbursed if ▲ the requirements for not showing a reduction in seizure frequency with other antiepileptic drugs are met or ▲ has a history of administration of antiepileptic drugs before Epidiolex.
However, the history of administration of antiepileptic drugs before administration of the drug means "the history of more than five of the 11 antiepileptic drugs prescribed in the detailed recognition criteria for care benefits being administered at sufficient internal medicine capacity."
The administration history should be checked by detailed medical records. The requirement for patients who have not shown a decrease in seizure frequency with other antiepileptic drugs refers to "the frequency of seizures did not decrease by more than 50% compared to the time of initial antiepileptic drugs even though more than five of the 11 drugs were administered with sufficient internal medicine."
Patients who administer Epidiolex only can be reimbursed in combination with Clobazam. If Clobazam cannot be administered, Epidiolex will be reimbursed if detailed medical records confirm it.
The HIRA also detailed the 'methods of assessment for sustainable investment'. It explained that for an additional 3 months after the first 3 months of Epidiolex administration, the seizure frequency should be reduced by more than 50% for the first 3 months of the drug, and for continuous additional administration after the first 6 months of the drug, the seizure frequency should be reduced by 50% or more.
In order to evaluate the appropriateness of continued administration of Epidiolex and prevent drug abuse, patients or guardians should fill out the seizure log with frequency of seizures and whether Epidiolex is administered, and medical institutions should manage it.
As for patients who have already been administered Epidiolex since April 1st, it is considered to meet the requirements for the benefit ▲if the criteria for detailed recognition of medical benefits at the time of initial administration of the drug, ▲if the 'subject to administration' requirements are met and can be verified through the details of the medical records, and ▲ five or more of the 11 types of antiepileptic drugs can be checked in detail in the medical records, and the necessity and appropriateness of the drug launch are considered to meet the requirements of the benefit unit if confirmed by a specialist.
It can be administered continuously if the assessment method for patients three months after Epidiolex administration for non-reimbursement meets Da-1 of the criteria for detailed recognition of medical benefits at the time of initial effectiveness assessment (three months after administration of the drug), or if the seizure frequency is maintained by more than 50% compared to the initial dose of the drug, or if it is confirmed by experts that treatment effects and continuous administration are necessary after the drug is started.
- Negotiations on the drug price of Onivyde have begun
- by Eo, Yun-Ho May 14, 2021 05:50am
- The new pancreatic cancer drug "Onivyde" is in the final stages of listing insurance benefits.
According to related industries, Servier Korea has recently entered pharmaceutical negotiations with the NHIS for the registration of Onivyde (Irinotecan HCl) under the order of the MOHW. As a result, attention is being paid to whether a new insurance benefit application drug can be created in the area of pancreatic cancer, which does not have many treatments.
Onivyde's application for benefits, which passed the HIRA's Pharmaceutical Benefits Advisory Committee on the 8th of last month, was approved. It is a combination of 5-FU/LV and secondary treatment in patients who fail Gemcitabine based primary care.
Through a global multi-organ three-phase clinical NAPOLI-1 study, Onivyde significantly improved treatment performance in combination with the existing secondary treatment option 5-FU/LV in patients who failed to receive Gemcitabine-based primary care.
Yoo Chang-hoon, a professor of oncology at Asan Medical Center in Seoul, said, "We currently talk a lot about secondary and tertiary drugs with a considerable number of pancreatic cancer patients. Since benefits are not applied, we will also examine whether there is an Indemnity Health Insurance Plan. "Onivyde has global phase 3, Asian data, and Korean RWE, but it's a pity that benefits are not yet applied." Leclaza (Lazertinib), the third-generation epithelial cell growth factor receptor (EGFR) of Yuhan, which passed the Pharmaceutical Benefits Advisory Committee with Onivyde, is also under drug negotiation. Considering the negotiation deadline, it is expected that the registration of both drugs will be decided between June and July.