The 6 most noteworthy medicine conformance evaluation varieties in 2019

Towards the end of 2018, the overall progress of the consistency evaluation is not ideal. It is not clear whether the country will adjust the consistency evaluation time limit of 289 varieties, but the signal sent by the 4+7 band purchase of national organizations is no longer clear: only through the consistency evaluation is the passing line of generic drugs, can the country be qualified to enter the market to replace the original research.This is exactly the reason why many non-289 varieties of enterprises rush ahead to carry out consistent evaluation work.

Up to now, although only 105 drugs (according to the acceptance number) have passed the consistency evaluation, there are many generic drugs of BE that enterprises have submitted applications or are carrying out, among which there are some blockbuster products and no enterprises have passed the consistency evaluation, so the market competition pattern is good.Today, we used PharmaGo and PharmaBI databases of the rubik's cube for medicine as tools to screen 14 most notable consistent evaluation varieties in 2019 for your reference.

Note: none of the 14 weighty varieties listed in this paper has passed the conformance assessment, including two situations: 1) some enterprises have submitted supplementary application for conformance assessment (CYHB), which has not been approved.2) some enterprises have submitted the listing application (CYHS) according to the new registration category 4, and the approval will be deemed to pass the consistency evaluation, but the approval has not been obtained.

NO.1 budesonide suspension for inhalation

Budesonide is an inhaled glucocorticoid with highly effective local anti-inflammatory effect for the treatment of bronchial asthma and asthmatic chronic bronchitis.Budesonide suspension for inhalation is the largest inhalation preparation variety in China with a sales volume of 4.29 billion yuan in 2017.

The market concentration degree of inhalation preparation is generally high. Inhalation budesonide suspension is monopolized by the primicoresulinshu of astrazeneca in China, and it has been monopolized for 14 years since it entered China in 2004. No domestic generic drugs have been listed for competition.

In the first half of 2018, cp tianqing, shenzhen wife pharmaceutical co., ltd. and changfeng pharmaceutical co., ltd. successively submitted their listing applications in accordance with the new 4 categories. If any of them can be approved in 2019, they will be deemed to have passed the consistent evaluation, breaking the situation that astrazeneca is the only one in China.

However, healthyuan released a notice on November 19, saying that it had received a clinical trial notice issued by the food and drug administration, and that it expected to re-launch the BE test and delay the listing process.The winner will be born in zhengda tianqing and changfeng pharmaceutical co., LTD.

No.2 teggio capsule

Tigeo capsule is a fluorouracil derivative oral compound anticancer chemotherapy, the active ingredients include tigafine, gemacil and otiracil, used for unresectable local advanced or metastatic gastric cancer.In 2017, the domestic sales of this variety is 2.8 billion yuan, and the manufacturers include shandong new era, hengrui, qilu and fuzhou haiwangfu pharmaceutical (tablet) in addition to the original research company dapeng in Japan.Among them, shandong new era occupies nearly 60% of the market share.

In terms of BE test registration, there is no competition except for listed manufacturers.Among them, both hengrui and qilu have completed BE and submitted supplementary applications for consistency evaluation.The BE test registered by shandong new era, which has the largest market share, is currently in the state of showing the completion of recruitment, but has not yet submitted the application for consistent evaluation.

No.3 capecitabine tablet

Capecitabine is a fluorouracil drug, a TYMS inhibitor, and a commonly used oral chemotherapy drug in clinical oncology, mainly used for the treatment of advanced breast cancer, colorectal cancer and gastric cancer.In 2017, the domestic sales of this variety is about 2.3 billion yuan, and the main manufacturers include roche (which entered China in 2007), cp tianqing, hengrui and qilu.

Hengrui applied for the consistency evaluation for the first time in January this year, but it was not approved. Instead, it got the approval of clinical trial and required to redo BE. It can BE seen that the consistency evaluation requirements of this variety are quite strict.Qilu has just submitted a conformance evaluation application on December 19.

Cp tianqing has not submitted the application for consistency evaluation, and it is still in the process of recruitment according to the progress shown in BE test.In addition, although no new 4 categories of the species have been reported, nanjing youke (completed) and chengdu yuandong biological (under recruitment) have also registered the BE test, which are worthy of attention.

No.4 Voriconazole for injection

Voriconazole belongs to the triazole class of antifungal drugs, which can induce fungal cell rupture and apoptosis by inhibiting the activity of 14-a-sterol demethylase dependent on fungal cytochrome P450.The main dosage forms of this variety are tablets and injections. In 2017, the domestic sales of voriconazole for injection was 1.67 billion yuan, of which Pfizer accounted for 45%.

The domestic manufacturers of voriconazole for injection include zhuhai yibang, lizhu, sichuan meidakang huakang and jincheng haisi.

At present, these four enterprises have not submitted the application for consistent evaluation.It is worth noting that qilu pharma and puli pharma are applying under the new four categories.In particular, the consistency evaluation of puli pharmaceutical injection is in the forefront in China, and voriconazole for injection has just been registered and approved by FDA on December 2, which does not rule out the possibility of coming from behind.

No.5 Sevoflurane for inhalation

Sevoflurane is a kind of flurane anesthetic, mainly used in preoperative anesthesia.Sevoflurane for inhalation is the best selling inhaled anesthetic at present, which belongs to the national class b medical insurance and has considerable difficulty in preparation technology.In 2017, the domestic sales volume of this variety is about 1.65 billion yuan.Domestic manufacturers include hengrui, lunan bate, hebei yipin, abbvi, Baxter medical and marushi pharmaceutical, among which hengrui occupies about 60% of the market share.

Among the domestic manufacturers mentioned above, hengrui has taken the Lead in submitting the application for consistent evaluation, while other manufacturers have not reported it.It seems that hengrui is far ahead, but what is interesting is that a company called fujian haixi united pharmaceutical co., ltd. has entered the stage of "approval" according to the new four categories of application, and if it is approved to go public, it may have an impact on the market pattern of this variety of hengrui.

No.6 valsartan capsule

Valsartan belongs to angiotensin II receptor antagonist class blood pressure drugs, through the antagonism of angiotensin Ⅱ type I receptor (AT1) and play the role of dilate blood vessels and reduce blood pressure.In 2017, the domestic sales of this variety will be about 1.45 billion yuan, accounting for 96% of the share of the original research company novartis.

Valsartan capsule belongs to 289 varieties, involving 10 domestic enterprises such as changzhou siyao, hainan aomeihua, China resources secco and tianda pharmaceutical co., LTD.In the last article, progress in consistency evaluation of the Top10 varieties of 289 catalog sales volume, it was also mentioned that lop was in the leading position in consistency evaluation and was expected to become the first enterprise to pass the consistency evaluation of valsartan capsules.

Changzhou siyao has just completed BE, and it is expected to submit a supplementary application soon. Yongxin, China resources secco, qianjin xiangjiang, shaanxi dongtai and other enterprises are carrying out BE tests.

Summary:

In this paper, oral solid preparation was used as the main method for selection and consistency evaluation of varieties, but some inhaled preparations and injections with distinctive characteristics were also included.At the same time, the progress of consistency evaluation of endemic varieties in China was also concerned.

Ned suspension liquid suction cloth (board) the weather is fine, for gonow capsule (hengrui or qilu), capecitabine tablets (qilu), voriconazole for injection (qilu pharmaceutical or split), the inhaled sevoflurane (fujian hercynian hengrui pharmaceutical or joint) and valsartan capsules (Germany), raigor column for mo nai (he) in jiangsu, thiazole amine capsule (tasly or double heron), succinic acid metoprolol zyban guide (south), escitalopram omeprazole magnesium enteric-coated metformin hydrochloride (terry) in suzhou, if all goes well in 2019 approved, will have a significant impact to the existing generics market pattern.