A Glimpse of the Latest Developments of the Second Half of Consistency Evaluation through the Top 5 Varieties

CFDA has generated 110 acceptance numbers for the generic drug consistency evaluation applications accepted by April 2, 2018, involving 51 varieties of 53 pharmaceutical enterprises.

CFDA has previously released the lists of two batches of varieties passing generic drug quality and efficacy evaluation, with 17 varieties of 27 specifications completed approval. According to statistics of insiders for varieties completed approval, the average review duration for generic drug consistency evaluation is about 150 days, the variety with the shortest review duration is the Tenofovir Disoproxil Fumarate Tablets of Chengdu Brilliant Pharmaceutical: 92 days, while the one with the longest review duration was Rosuvastatin Calcium Tablets of Zhejiang Jingxin Pharmaceutical: 234 days.

See the following table for the top 5 varieties in consistency evaluation sorted by the application acceptance number, which are separately Amlodipine Besylate Tablets, Rosuvastatin Calcium Tablets, Irbesartan Tablets, Cefuroxime Axetil Tablets, and Escitalopram Oxalate Tablets.

Amlodipine Besylate Tablets

Amlodipine Besylate Tablets is currently the variety with the highest proportion on the calcium antagonist market segment of China, which is about 30.51%. According to data of menet.com, the relevant market size of city public hospitals in China was about RMB 2.919 billion in 2016, wherein, the original drug: Pfizer’s Norvasc accounted for more than 72% market share. There have been 65 approvals for Amlodipine Besylate Tablets in China, and the Chinese enterprise with the highest market share is Yangtze River Pharmaceutical, which is about 4.12%, while the market share of Jiangsu Yellow River Pharmaceutical is less than 1%.

There have been 5 pharmaceutical enterprises filing application for this variety, wherein, Jiangsu Yellow River Pharmaceutical is the first in passing the consistency evaluation, and Yangtze River Pharmaceutical’s application progress is behind Yellow River Pharmaceutical and the enterprise is expected to become the second enterprise that passes the consistency evaluation of that variety.

Rosuvastatin Calcium Tablets

Rosuvastatin calcium belongs to the the third-generation statins, and continues to grow upon better safety and dosage advantage on the Chinese market. The original drug is AstraZeneca’s Crestor which was marketed in China in 2007. The relevant market size in China is about RMB 5 billion, with the imported drug proportion exceeding 50%.

There have been 4 enterprises filing application for this variety, wherein, the 10mg product of Chia Tai Tianqing and 10mg and 5mg products of Zhejiang Jingxin have passed the approval.

Irbesartan Tablets

Irbesartan belongs to angiotensin II receptor blockers and is mainly used to treat essential hypertension, type 2 diabetes with hypertension, and nephropathy. The original drug is Sanofi’s Aprovel which was marketed in China in 2000. From the historical data, the market share of the original product has been over 77% on the Irbesartan Tablets market in China.

There have been 3 enterprises filing application for this variety, wherein, the 75mg, 150mg, and 300mg products of Hisun-Pfizer and 75mg product of Huahai Pharmaceutical have been approved.

Cefuroxime Axetil Tablets

Cefuroxime axetil belongs to the semi-synthetic, second-generation, broad-spectrum cephalosporins, and was a variety among the global top 10 antibiotics by sales. There have been over 10 enterprises marketing this product, with low concentration. The original product is GSK’s Zinacef.

There have been 3 enterprises filing application for this variety, wherein, the 0.25g product of Sinopharm Zhijun is the first in passing the consistency evaluation.

Escitalopram oxalate

Escitalopram oxalate belongs to SSRIs, and is currently the best-selling variety among the antidepressants in China, with the market size of about RMB 2 billion in 2016. The original drug is Lexapro of Lundbeck A/S, which was marketed in China in 2005. From the perspective of the 2017 sales, the original product accounted for about 60% market share, followed by Jewim Pharmaceutical and Kelun Pharmaceutical.

There have been 3 enterprises filing application for this variety, wherein, the 10mg product of Kelun Pharmaceutical is the first in passing the consistency evaluation.

The first-mover advantages benefit variety growth, regardless of whether they belong to 289 Catalog

According to arrangements of the generic drug quality and efficacy consistency evaluation work, the end of 2018 is the deadline for the consistency evaluation of varieties that belong to Catalog of 289 essential drugs, while varieties outside such catalog are not subject to this deadline.

Among the above top 5 varieties, Rosuvastatin Calcium Tablets, Irbesartan Tablets, and Escitalopram Oxalate Tablets are not varieties of Catalog of 289 essential drugs. Seen from the application situation, the competition of Chinese pharmaceutical enterprises for those varieties has already begun, the reason for which may be the big potential market behind those big potential drug varieties. Being the first in getting the admission tickets to consistency evaluation means enterprises can enjoy different policy benefits, and take opportunities to expand market size of own varieties and even beat competitors.

Take Escitalopram Oxalate Tablets for instance, the penetration of the psychotropic drugs is low in China, and Escitalopram Oxalate Tablets is currently the best-selling antidepressant variety in China, therefore, the rapid growth of its market size in the future is expectable, and naturally it will be chased after by the pharmaceutical enterprises. The current market share of Kelun Pharmaceutical is about 10.4%, and the first-mover advantage resulting from its product being the first in passing the consistency evaluation will help Kelun Pharmaceutical significantly increase its market share in the future.

Two growth paths

Among the above top 5 varieties, from the perspective of the market shares of original products, Amlodipine Besylate Tablets, Rosuvastatin Calcium Tablets, Irbesartan Tablets, and Escitalopram Oxalate Tablets are varieties of which the original products have high market shares, with big space and potential of import substitution; latecomers can achieve growth by seizing shares of imported products. While Cefuroxime Axetil Tablets is the variety of which the original product has a low proportion, and the concentration of existing branded products is low, therefore, the enterprise that is the first in passing the consistency evaluation can achieve growth of own variety by capturing shares of other enterprises.

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