Sandoz's Rosuvastatin Calcium Tablets Become First Imported Generic Drug to Pass China's Consistency Evaluation

Recently, Novartis announced that its generic drug subsidiary Sandoz’s “Rosuvastatin Calcium Tablets” had passed the Generic Drug Consistency Evaluation conducted by the National Medical Products Administration (NMPA). This product is the first drug manufactured by a foreign pharmaceutical company to be marketed in China after passing the domestic consistency evaluation, marking a milestone for imported generic drugs in the Chinese market. The approval of Sandoz’s Rosuvastatin through the consistency evaluation signifies that imported generic drugs are now also required to participate in the consistency evaluation process.

Data from the National Medical Products Administration (NMPA) website indicates that rosuvastatin, manufactured by Lek Pharmaceuticals d.d., a subsidiary of Sandoz, is available in multiple strengths, including 5 mg, 10 mg, and 20 mg. The manufacturer, Lek, is located in Slovenia and was previously acquired by Sandoz. Furthermore, according to the standardized package insert displayed in the database, the drug is primarily indicated for primary hypercholesterolemia in patients whose dyslipidemia cannot be adequately controlled through dietary management and other non-pharmacological interventions, such as exercise and weight reduction. Additionally, this medication is a prescription drug and must be used under the guidance of a physician. It is contraindicated during pregnancy, lactation, and in women of childbearing potential who are not using appropriate contraceptive measures.

As a popular blockbuster lipid-lowering agent, rosuvastatin represents one of the largest pharmaceutical markets in China. The originator drug is Crestor, manufactured by AstraZeneca. To date, five domestic pharmaceutical companies have passed the consistency evaluation for their generic versions, with the specific distribution as follows:

Chia Tai Tianqing: 10 mg specification, December 27, 2017;

Jingxin Pharmaceutical: 5 mg/10 mg strength, February 9, 2018;

Hisun Pharmaceutical: 5 mg/10 mg strength, 2018/7/6;

Simcere Pharmaceutical: 10 mg specification, 2018/10/8;

Lunan Pharmaceutical: 5 mg/10 mg strength, February 26, 2019.

According to data from Menet, the terminal sales of rosuvastatin calcium tablets in Chinese public medical institutions reached RMB 5.02 billion in 2017. Among them, AstraZeneca accounted for 56.71%, Lunan Better 13.70%, Jingxin Pharmaceutical 13.37%, Chia Tai Tianqing 12.61%, Hisun Pharmaceutical 1.98%, and Simcere Dongyuan 1.63%.

With Sandoz’s product now passing the consistency evaluation, a total of six manufacturers will engage in fierce head-to-head competition with AstraZeneca, the originator of Crestor.

(Image source:Pharmaceuticals(Compiled by Cloud Studio)

Intensifying Market Competition Continues to Escalate: On April 26, the Center for Drug Evaluation (CDE) website announced that Zhejiang Jiangbei Pharmaceutical had submitted a New Drug Application (NDA) under Category 4 for a generic version of rosuvastatin. Despite the challenges, this active pharmaceutical ingredient (API) manufacturer has ventured into the finished dosage form sector, making Jiangbei Pharmaceutical the sixth domestic company to seek market approval for rosuvastatin calcium tablets. Data from the Menet database shows that, in addition to generic products that have already passed the consistency evaluation, there are 13 rosuvastatin calcium tablet applications currently in the supplementary submission stage for consistency evaluation, and 27 applicants conducting bioequivalence (BE) studies. In total, 79 manufacturers in China have filed applications, illustrating the fierce competition in the rosuvastatin market.

Although AstraZeneca currently holds a significant market share in China (in 2018, Crestor’s sales in China reached $456 million, representing a 22% increase), Zhejiang Jingxin Pharmaceutical won the bid for rosuvastatin in the “4+7 Volume-Based Procurement” initiative at the end of last year, with a price of RMB 21.8 per box (10 mg × 28 tablets), marking a 76% price reduction. This means that other companies have virtually lost their rosuvastatin market in these 11 cities.

Early this year, AstraZeneca and Luye Pharma signed an agreement granting AstraZeneca exclusive promotional rights for the proprietary Chinese medicine Xuezhikang capsules in mainland China. This move set a precedent for large multinational pharmaceutical companies entering the field of proprietary Chinese medicines, sparking widespread discussion within the industry. Xuezhikang is Luye’s patented traditional Chinese medicine indicated for the treatment of hyperlipidemia and remains one of Luye’s flagship products. Some industry observers view AstraZeneca’s acquisition of the promotional rights to Xuezhikang as a strategic pivot and fresh start following the loss of its statin franchise.

It is argued that for Novartis, although Sandoz’s rosuvastatin has successfully passed the consistency evaluation, the overheated domestic competitive landscape is clearly not optimistic. It will inevitably face head-to-head competition with both the originator company and local enterprises such as Jingxin Pharmaceutical. Perhaps the key takeaway from the harsh competitive environment surrounding rosuvastatin is that passing the consistency evaluation is not a shield but an entry ticket; only by leveraging multiple dimensions, including marketing, can one emerge as the ultimate winner amidst significant industry changes.