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Company
Tylenol sales jump 140% due to the pandemic
by
Chon, Seung-Hyun
Aug 24, 2021 06:05am
Sales of the OTC antipyretic analgesic ‘Tylenol’ have soared. With the increased demand among people receiving the COVID-19 vaccinations, Tylenol sold ₩43.6 billion in the first half of this year, which is twice more than that sold in the whole term of last year. There has been criticism that the government’s recommendation to take Tylenol in the early phases of inoculation has promoted sales of specific brands. According to the pharmaceutical research institution IQVIA on the 23rd, sales of Tylenol Tab. and Tylenol 8 hours ER Tab. had sold 139.6% more year-on-year to record ₩43.6 billion in the first half of this year. Tylenol’s sales increased 167.9% YOY to record ₩33.6 billion, and sales of Tylenol 8 hours ER Tab. increased 77.0% YOY to record ₩10 billion. Tylenol and Tylenol 8 hours ER are both antipyretic analgesics containing the single-ingredient acetaminophen. Sales of both Tylenol and Tylenol 8 hours ER had surged in Q2 this year. Tylenol’s sales in Q1 increased 25.9% YOY to ₩8.1 billion, but expanded further in Q2 to increase 318.6% YOY to record ₩25.5 billion. Tylenol 8 hours ER sold ₩2.5 billion in Q1, which was a 27.9% decrease YOY to ₩2.5 billion, but sales of the product rebound in Q2 to rise 253.5% YOY and record ₩7.5 billion. Sales have increased with those receiving COVID-19 vaccinations buying Tylenol in advance to prepare for fevers or muscle aches. Inoculations started in Korea in late February, and with the number of people receiving vaccination increasing, demand for antipyretic analgesics has also surged. Also, there has been criticism over the government’s contribution to the surge of sales. The government authorities have informed people receiving COVID-19 vaccinations that “it is good to take Tylenol when fevers or other side effects arise after vaccination.” Since then, the demand for Tylenol took a sudden leap and led to shortages in its stock. Due to the continued instability in the supply of Tylenol, the government belatedly set out to address the issue. In May, the Ministry of Food and Drug Safety had announced that around 60 single-ingredient acetaminophens products are being sold in the market, and guided citizens to purchase other products. In June, the Ministry of Food and Drug Safety, Korean Pharmacists’ association, Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Korea Pharmaceuticals Distribution Association, and Tylenol’s manufacturer Johnson & Johnson had agreed to work together to stabilize the supply of acetaminophen. The Korea Pharmaceuticals Distribution Association had made emergency measures to promptly supply the acetaminophen that they received to all pharmacies nationwide. The MFDS also discussed measures with the Korea Pharmaceuticals Distribution Association and Johnson & Johnson Korea to expand the supply of Tylenol to pharmacies nationwide. However, other acetaminophen products did not enjoy such an increase in their sales. Sales of major acetaminophen agents in Korea have shown that sales of Samjin Pharm’s ‘Geborin’ fell 30.3% YOY to record ₩6.6 billion in the first half of this year. Geborin’s sales fell 6.9% YOY in Q1, then increased 8.3% YOY in Q2, and did not benefit from the increased number of COVID-19 vaccinations. Sales of Chong Kun Dang’s ‘Penzal Q’ and ‘Penzal 8 hours ER’ fell 7.2% YOY to record ₩2.2 billion in the first half of this year. In fact, acetaminophen’s position in the market had become unstable with the constant safety issues that were being raised recently. The MFDS has strengthened the safety measures for prolonged-release forms of acetaminophen-containing agents in 2018 to reduce risks from overdose such as liver damage etc. The authorities reduced the package units to less than the maximum daily dose and indicated the dosing interval (8 hours) in the product name. In 2011, the strength of each dosage unit of prescription acetaminophen products was restricted to 325mg due to the risk of liver damage and allergic reactions. In addition, an impurity concern arose last year. In July last year, the acetaminophen API manufactured and supplied by the Chinese API manufacturing company Anqiu Lu'an Pharmaceutical was found to be contaminated by 4-Chloroaniline. The Ministry of Food and Drug Safety announced that it had collected and inspected a total of 60 lot numbers from all manufactories and that the impurity in question was not detected. However, the sudden spread of the pandemic and the increase in vaccinations have brought an upsurge in sales of Tylenol. Sales of the 4 Tylenol series products including Tylenol Cold S and Women’s Tylenol have recorded ₩45.1 billion, increasing 122.2% compared to the previous year.
Company
Ono Pharma Korea’s Braftovi has been approved in Korea
by
Aug 24, 2021 06:05am
Ono Pharma Korea announced on the 23rd that it has been approved by the MFDS on the 19th by Braftovi (Encorafenib), a direct bowel cancer treatment. BRAF inhibitor Braftovi can be used as a combination therapy with Erbitux (Cetuximab) in adult patients with direct colon cancer with previous treatment experience and confirmed BRAF V600E mutation. In Korea, the positive BRAF V600E gene mutation is found in 4.7% of patients with direct bowel cancer. There were no approved drugs based on effectiveness in BRAF gene-variant bowel cancer, requiring a new treatment choice. This approval is based on the results of BEACON CRC study in patients with non-ablastic progressive or recurrent direct colon cancer showing BRAF V600E mutation after primary or secondary treatment. In the study, combined therapy of Braftovi-Cetuximab is a control group, and the overall survival period (OS) compared to Irinotecan (Iritecan)-Cetuximab based combination therapy showed statistically significant extensions (HR 0.60, p=0.0003). OS median was 8.4 months for Braftovi group and 5.4 months for control group.
Policy
The effectiveness of NIP expansion policy?
by
Aug 24, 2021 06:05am
Moon Jae-in president announced to expand under the age of 17 for vaccine against cervical cancer vaccination for free, while the few people seemed to be criticizing as 'show off'. President Moon said he would expand the vaccination target from the age of 12 to the age of 17 to mark the 4th anniversary of the petition. In the past, people aged 13 to 17 were eligible for free vaccination, and 70 to 80% had already been vaccinated. Some point out that it is a show off policy because the number of people actually receiving support is small. President Moon said in a video on the 19th, "We will allow all women and teenagers to receive free vaccination benefits," marking the 4th anniversary of the introduction of Cheongwadae's petition. Cervical cancer is the only cancer that can be prevented by vaccination, but many asked for more support due to the cost of ₩600,000. Recently, the price of inoculation has increased and the burden has increased, leading to a national petition. If the expansion plan is implemented, women aged 13 to 17 will also have a chance to receive a free vaccine. However, not many people are expected to receive actual benefits. The expanded number of female teenagers aged 13 to 17 was already eligible for free vaccination. The human papilloma virus (HPV) vaccine to prevent cervical cancer has been designated as NIP since 2016 and has been implemented for 12-year-old girls. People born in January 2003 and December 2004 were the first targets. These are the 17-year-olds, the highest-age group President Moon said he would expand. It is pointed out that it seems to include an age that was not previously applicable while targeting people who were vaccinated for free in the past. Even if the expansion plan is implemented immediately, only those of female teenagers aged 13 to 17 who missed the timing of vaccination in the past can receive support benefits. According to the KDCA, the primary vaccination rate in 2003 was 61.5% in the first year. The primary inoculation rate was 72.6% for those born in 2004. 87.2% of those born in 2005 have already been vaccinated. President Moon said, "For women aged 18 to 26, we will gradually expand the scope of vaccinations by allowing low-income people to receive free vaccinations." Also, there was no mention of men implemented by half of the 36 OECD countries, including advanced countries such as the United States, Canada and the United Kingdom. Kim Jae-yeon, chairman of the Korean Association of Obstetricians & Gynecologists, said, "It is an ineffective demonstration policy to expand the scope to female teenagers aged 13 to 17 who have already received free vaccinations." He pointed out that "in effect, the government should suggest ways to increase the vaccination rate and prevent cervical cancer."
Company
Will the issue of GLT-2 inhibitors be resolved in 3 years?
by
Eo, Yun-Ho
Aug 23, 2021 10:28pm
Attention is focusing on whether the issue of combined benefits of DPP-4 inhibitors and SGLT-2 inhibitors will finally be solved. According to academia, the HIRA will hold a meeting of experts on September and discuss the combined benefits of oral diabetes treatment DPP-4 inhibitors and SGLT-2 inhibitors. The issue, which has been almost three years, was put on full hold in 2018 when the government planned a "public notice of improvement of the benefits standard for each drug" to strengthen convenience at the medical sites and patient guarantee, but pointed out that there was insufficient evidence of validity of drugs without separate clinical research. It was the opinion of the medical community that the government should discuss expanding the combined benefits of diabetes drugs. Each drug in the same category has different indications, causing side effects such as confusion at the prescription site and cuts in insurance benefits. The same was true when the combined benefits between DPP-4 inhibitors and TZD-related drugs expanded in 2013. However, the results are different. The medical community, which has emphasized the importance of clinical experience and expert judgment rather than permission and financial impact, is also unusual. It started in 2013 when Yoon Gun-ho, a professor at Seoul St. Mary's Hospital who actively expressed his opinion to expand the benefit of diabetes drugs, became the chairman of the Korean Diabetes Association. He conveyed to the government that health insurance can be applied by affiliates as an expert's recommendation, and in August last year, the MFDS said it would "simplify" the registration method of diabetes drugs. It said that it was to reflect permits from the U.S. and Europe and the demands of the medical community and industry, but many in the industry believed that it was a cornerstone for preparing standards for combination therapy. As a result, pharmaceutical companies submitted simplified labels for the efficacy of diabetes treatments from November of the same year, and the MFDS approved Jardiance, Forxiga, Suglat, and Steglatro sequentially in the first half of this year. Companies with such drugs immediately submitted applications for expansion of combined benefits, but so far, the agenda has not been submitted to the Subcommittee. An industry official said, "We hope that this expert discussion will solve the unfulfilled demand of clinical sites. As we have accumulated experience in prescribing SGLT-2 inhibitors in Korea, we expect positive results."
Policy
Over 40mil COVID-19 vaccines cleared for release in 6 mos
by
Lee, Tak-Sun
Aug 23, 2021 05:55am
Ministry of Food and Drug Safety The number of COVID-19 vaccines granted National Lot Release in Korea has exceeded 40 million. The large-scale batches of Pfizer vaccines introduced in late July have accelerated the number of vaccines approved for lot release. According to the Ministry of Food and Drug Safety on the 22nd, 1.6 million doses (for 800 thousand people) Pfizer Korea’s ‘Cormirnaty inj. (tozinameran)’ were approved for National Lot Release on the 20th. The cumulative number of doses approved reached 41.263 million with the release, exceeding 40 million doses for the first time in 6 months since the first lot of COVID-19 vaccines were released on February 17th. The National Lot Release system is the final quality inspection system conducted by the MFDS before releasing appropriate products for marketing approval. Only COVID-19 vaccines that were officially approved are counted, and vaccines supplied by COVAX Facility or from other countries are not subject to the national lot release. With vaccinations now in full scale for people less than 50 years of age in Korea, most of the vaccines approved for lot release are Pfizer vaccines. Over 1 million doses of the Pfizer vaccine have been supplied since the end of July. 코로나19백신 국가출하승인 현황(식약처 자료 발췌) However, the amount approved for national lot release and the number of people vaccinated differ. The use of vaccines that did not go through the national lot release system and the use of the low dead space syringe has increased the number of those vaccinated. According to the Korea Disease and Prevention Agency, 25,866,970 people received their first vaccination, and 11,562,518 people completed vaccinations as of 22nd, 12:00 p.m. In other words, 50.4% of the population has received the first dose, and 22.5% of the population has been fully vaccinated. Among those that received the first dose of the COVID-19 vaccine, 10,836,390 received the AstraZeneca vaccine, 11,620,319 received the Pfizer vaccine, 2,280,477 received the Moderna vaccine, and 1,129,784 received the Janssen vaccine. Only 101,000 doses of the Janssen vaccine were approved through the National Lot Release, however, much more people were able to be vaccinated with Janssen vaccines that were provided by the U.S., which did not pass through the National Lot Release system. A total of 2,454,000 doses of the Moderna vaccine, which had seen a disruption in supply recently, were approved through the National Lot Release system. Currently, the Korean Ministry of Food and Drug Safety has approved 4 COVID-19 vaccines from AstraZeneca, Pfizer, Janssen, and Moderna.
Policy
Perjeta's price was down 10% to ₩2,214,600
by
Kim, Jung-Ju
Aug 23, 2021 05:55am
Five drugs that succeeded in insurance benefits in Korea due to Risk Sharing Agreement (RSA) have been re-contracted by lowering drug prices to the expiration of the contract. According to the industry, the MOHW is recently pushing to revise the list of drug benefits aimed at the 1st of next month for a total of five successful drugs negotiated by the NHIS and the pharmaceutical companies. The drugs are Roche Korea's Perjeta (Pertuzumab) and Novartis' Meqsel (Trametinib Dimethyl Sulfoxide) , which will reduce existing drug prices by at least 0.5% and at most 10%. Perjeta's prices were down 10% from ₩2,465,60 to ₩2,214,600. The price of Meqsel will be reduced from ₩128,344 to ₩127,639, and Meqsel 0.5mg will be lowered from ₩32,086 to ₩31,910, respectively.
Company
Accumulated exports of K-Biosimilars reach ₩9Tril
by
Chon, Seung-Hyun
Aug 23, 2021 05:55am
Cumulative exports of biosimilars developed by Celltrion and Samsung Bioepis exceeded ₩9 trillion. Growth has slowed compared to the products’ first market entry, however, the products have been marking stable growth based on their solid pipeline. ◆Celltrion Healthcare exports ₩789.5billion in H1…cumulative sales exceed ₩6 trillion According to the Financial Supervisory Service on the 19th, Celltrion Healthcare’s exports reached ₩789.5 billion, a 1.6% increase from the ₩777.2 billion in the same period last year. Although growth was not as explosive as in the previous year, the company still recorded large-scale overseas exports. Celltrion Healthcare is an affiliate of Celltrion that has Celltrion Healthcare Holdings (share 24.3%) as its largest shareholder. Celltrion Healthcare sells antibody biosimilar products that it received from Celltrion to global distributors. In other words, Celltrion Healthcare’s sales refer to the export performance of biosimilars developed by Celltrion. Celltrion Healthcare is selling 4 biosimilar products including ‘Remsima,’ ‘Truxima,’ ‘Herzuma,’ and ‘Remsima SC’ in the global market. Remsima’s original is Janssen’s ‘Remicade.’ Remsima SC is a subcutaneous injection formulating of Remsima. Truxima and Herzuma are biosimilars of ‘MabThera’ and ‘Herceptin,’ respectively. By each product, Remsima sold the most in exports, recording ₩302.1 billion in H1 this year. Adding Remsima SC(₩35.1), the Remsima brand sold ₩337.3 billion in exports in H1 this year. Remsima is the first biosimilar product that was approved in 2012. It had annually recorded the highest export sales among all Celltrion’s biosimilars but was outrun by Truxima’s record of ₩786.8 billion last year. However, this year, sales of Remsima again surpassed that of Truxima and became the No.1 product in exports. Truxima’s export sales fell 25.3% YOY from ₩365.8 billion to ₩273.3 billion in H1 this year. The company explained that Truxima’s sales in Q1, which saw a 32.6% YOY decrease to mark ₩109.7 billion, was due to a temporary adjustment in the supply schedule of its products. Herzuma’s export sales in H1 this year were ₩102.3 billion, a 25.7% YOY increase. Herzuma’s share in the European market in Q1 was 15%, a slight decrease from the 19% it held in Q1 last year. However, in the Japanese market, its share exceeded that of its originator Herceptin, to record 50%. This was more than a twofold market expansion in a single year from the 25% share it held in Q1 last year. Celltrion Healthcare, which was listed on KOSDAQ in 2017, has been recording its export performance in its business report since 2014. Since 2014, Remsima and Remsima SC have recorded the most in exports with a cumulative record of ₩3.7123 trillion. Truxima, which started making export performance in 2017, marked ₩1.9925 trillion, and Herzuma’s cumulative exports amounted to ₩575.1 billion. On whole, Celltrion Healthcare’s cumulative exports from 2014 to H1 this year marked ₩6.3 trillion. ◆Samsung Bioepis makes ₩354.2 billion in H1… cumulative sales record ₩2.0889 trillion Samsung Bioepis’s operating profit last year was ₩145 billion, an 18.1% YOY increase from the same period of the previous year. Since it recorded its first profit in 2019 with ₩122.8 billion, its profit has grown even more in a single year. Samsung Bioepis recorded ₩187.5 billion in sales in Q2, which is a 22.7% YOY increase. The company had continued on a downward roll since Q3 of last year, when it recorded its all-time high with ₩236.9 billion, however, in only 2 quarters since then, the company has recovered its performance to a level similar to its pre-COVID-19 performance. The accumulated sales of Samsung Bioepis in the 1H of this year rose 5.5% compared to the same period of last year, to record ₩354.2 billion Most of its sales were generated from overseas sales of the company’s self-developed biosimilars. Samsung Bioepis had succeeded in commercializing 5 biosimilars of biopharmaceuticals – ‘Enbrel,’ ‘Remicade,’ ‘Herceptin,’ ‘Humira,’ and ‘Avastin.’ In the global market, the company has signed marketing partnership agreements with multinational pharmaceutical companies such as Biogen and Organon to sell its products. Biogen is in charge of the local distribution and sales of the three autoimmune treatments, ‘ Benepali,’ ‘Flixabi,’ and ‘Imraldi.’ Organon (formerly known as MSD) is selling the three products in countries other than the U.S., Korea, and China, as ‘Renflexis (Remicade biosimilar), ‘Brenzys (Enbrel biosimilar),’ ‘Hadlima (Humira biosimilar).’ Organon is also in charge of selling the two anticancer drugs - the Herceptin biosimilar ‘Ontruzant’ and Avastin biosimilar ‘Avincio’ – abroad. According to performance reports by Biogen and Organon, biosimilars of Samsung Bioepis had made $573 million (approximately ₩675 billion) in H1 this year. Sales made by Biogen rose 4.3% YOY to record $407 million (approximately ₩470 billion). Sales made with biosimilars through Organon were $166 million (approximately ₩195 billion). Although the drugs sold less in comparison to its performance in the European market, its growth of 43.4% YoY has been received positively due to its growth potential. Due to the preorders that were made in Q1, sales in Q2 had decreased, then rose sharply in the second half of the year with the technology fee (milestone payments) from signing biosimilar license agreements with Chinese companies such as S Bio and C-Bridge Capital in 2019 being reflected in the revenue. This year, sales have stabilized to record ₩166.7 billion in Q1 and ₩187.5 billion in Q2. Samsung Bioepis, which was established in 2012, had shown full growth since recording ₩147.5 billion in sales in 2016. Last year, sales increased over fivefold compared to four years ago. Since its launch in 2012, Samsung Bioepis has recorded a cumulative sales of ₩ 2.8895 trillion. Most of Samsung Bioepis' sales come from overseas sales of biosimilars or technology fees. Its domestic sales contributions are small compared to exports. In other words, Celltrion and Samsung Bioepis’ combined exports of biosimilars recorded over ₩ 9 trillion in total.
Policy
AstraZeneca vaccine has been approved in 121 countries
by
Lee, Tak-Sun
Aug 23, 2021 05:55am
The most widely approved coronavirus vaccine in countries around the world was AZD1222, co-developed by AstraZeneca and Oxford University. AZ vaccine was the first approved COVID vaccine in Korea in February. According to the MFDS, the KOBIA, abd the national vaccine safety technology support center, AZ vaccine was approved in 121 countries around the world, with the largest number of licensed countries among COVID-19 vaccines. AZ vaccine has been tested in the largest number of countries, with 35 clinical trials in 19 countries. Developed by Pfizer and BioNTech, BNT162b2 has been licensed in 97 countries around the world. It was also granted the second COVID-19 vaccine in Korea following AZ in March. Pfizer vaccine was found to have carried out 31 clinical trials in 17 countries. The third most licensed vaccine was Sputnik V, developed by Russia's The Gamaleya Research Institute of Epidemiology and Microbiology, which was licensed in 70 countries. It is a product that has not yet been licensed in Korea, and Huons, which produces the vaccine on consignment, applied for a preliminary review before applying for permission in April. Unlike AZ and Pfizer vaccines, Sputnik V did not receive WHO's Emergency Use Authorization. The fourth most licensed vaccine is Moderna's mRNA-1273 vaccine, which has been approved for use in 65 countries. Moderna vaccine was approved in May in Korea. It was approved in the order of Ad26.COV2.S (59 countries), Sinopharm's BBIBP-CorV (53 countries), India's Serum Institute's Covishield (45 countries) and Sinovac's CoronaVac' (32 countries). In Korea, a total of four types of vaccines, including AZ, Pfizer, Modena and Janssen, have been granted, and vaccinations are underway. The WHO's EUA includes seven vaccines: Moderna, Pfizer, Janssen, AZ, Serum Research Institute, Sinopharm and Sinovac. The WHO's Emergency Use Authorized vaccines can be used by reference to countries that have difficulty in screening drugs alone.
Policy
Women under the age of 17 will be given Gardasil 9 for free
by
Lee, Jeong-Hwan
Aug 23, 2021 05:55am
President Moon Jae-in is answering directly to celebrate the 4th anniversary of the petition. He promised the government will expand the scope of free cervical cancer vaccinations from women under the current age of 12 to under the age of 17 so that all women and teenagers can receive free vaccination benefits. He said he would also make efforts to expand the workforce and improve the working environment and treatment of nurses at health centers who are responding to COVID outbreak. On the 19th, President Moon directly responded to the public to mark the 4th anniversary of the petition. President Moon has declared more support for cervical cancer vaccinations. This is the answer to 18,817 people's petition to oppose the increase in the amount of the cervical cancer vaccine Gardasil 9 and to apply insurance premiums. There are a total of 48 requests for cervical cancer vaccine support. The standard is to respond when more than 200,000 people agree, but President Moon said, "A small number of agreements does not mean less important." President Moon said, "Cervical cervical cancer is the only cancer that can be prevented by vaccination, but it is often not vaccinated due to the cost of up to ₩600,000." He said, "We will expand the scope of free vaccination for cervical cancer from women under 12 to under 17 years of age and receive free benefits for all female teenagers." President Moon said, "We will allow low-income women aged 18 to 26 to receive free vaccinations and gradually expand the scope." It also mentioned hiring nurses and improving treatment at health centers, which are essential workers in response to COVID-19. 65,385 people have joined the petition to prevent nurses at health centers from collapsing. "We have hired 1,273 nurses in the first half of this year, and we are hiring 2,353 more people to respond to infectious diseases this month," President Moon said. "We will continue to expand the number of nurses and improve the working environment and treatment." In addition, President Moon promised to expand medical support for the infertility and strengthen support for vacation, preferential vaccination of COVID to caregivers and delivery call centers and visiting service workers. Furthermore, President Moon announced his plan to introduce a system that will allow government agencies such as the National Assembly, courts, Constitutional Court and the National Elections Commission to file petitions online at the end of next year.
Policy
Lyrica CR generics begin development...PMS expires next July
by
Lee, Tak-Sun
Aug 20, 2021 05:56am
Development for generics of Pfizer’s pain reliever ‘Lyrica CR,’ whose post-market surveillance (PMS) period expires in July next year, has begun. Unlike Lyrica, which is taken twice a day, Lyrica CR is a once-daily formulation and is used for peripheral neuropathic pain in adults. With more than 80 pharmaceutical companies participating in the development of Lyrica generic, attention is focused on whether such avid interest will be shown for Lyrica CR as well. On the 17th, the Ministry of Food and Drug Safety approved the bioequivalence study protocol for Dasan Pharmaceutical’s DSP2102. The study will assess the bioequivalence of Dasan Pharmaceutical’s ‘DSP2102’ and Pfizer Pharmaceuticals Korea’s ‘Lyrica CR 300mg’ on 34 healthy adult participants. Dasan’s study will be the first to compare a drug with Lyrica CR. The PMS period for Lyrica CR, which was approved in July 2018, will expire in July next year. The move to conduct bioequivalence tests for the development of generics has begun as approval for generics is possible upon expiry of the PMS period. Lyrica is a leading product in the domestic pain reliever market. Lyrica sold 52.9 billion won according to IQVIA last year. However, Lyrica CR’s performance is not as significant as Lyrica’s as it has been released relatively recently, has a limited indication, and has viable competitors. In the same period, Lyrica CR only made 700 million won in sales. However, when considering that around 80 generic companies entered the market after Lyrica’s substance patent expired in 2012, the possibility remains that latecomers in the field will show an interest in the more convenient, less frequently taken Lyrica CR. However, with market competitors already existing in the market and new regulations in place for development, the number of companies jumping in to develop Lyrika CR generics is expected to be less than that for Lyrica. Six other companies including Yuhan Corp. own once-daily drugs containing the same ingredient as Lyrica CR. The products entered the market only a few months after the original, and the companies have been enjoying the first-mover advantage. Also, due to the restriction limiting each consigner to share its bioequivalence tests with only three consignees, the burden of companies needing to develop generic drugs themselves will have an effect in reducing the number of products seeking market entry. The use of Lyrica CR is limited compared to Lyrica, as it can only be used to treat peripheral neuropathic pain in adults. On the other hand, Lyrica is additionally indicated for epilepsy (as adjunctive therapy for partial-onset seizures with or without secondary generalization) and fibromyalgia.
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