On May 27, Qilu Pharmaceutical’s marketing application for Atorvastatin Calcium Tablets (CYHS1700609, CYHS1700612) was approved by the National Medical Products Administration (NMPA).
Source: PharmaCube PharmaGo
Qilu Pharmaceutical conducted a bioequivalence study on atorvastatin calcium tablets 20 mg (CTR20171096), adopting the strategy of waiving bioequivalence studies for lower strengths based on data from the higher strength. On March 5, 2018, marketing applications for both the 10 mg and 20 mg strengths were simultaneously submitted under the new classification system for chemical drugs.
Following this approval, Qilu Pharmaceutical became the fourth domestic generic drug manufacturer to market Atorvastatin Calcium Tablets and the fourth company to pass the consistency evaluation for this product.
1. Dozens of Companies Vie to Develop Generic Versions of Blockbuster Lipid-Lowering Drugs
Atorvastatin is a selective inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase. It is indicated for the treatment of heterozygous familial or non-familial hypercholesterolemia and mixed dyslipidemia, as well as homozygous hypercholesterolemia. As the first drug globally to achieve annual sales exceeding $10 billion, it initiated a sales myth for small-molecule drugs in the history of new drug development.
Just before the original Lipitor entered China in 1999 and received administrative protection, Jiulin Pharmaceutical’s atorvastatin calcium tablets (Ale) were approved for market launch. After the administrative protection for Lipitor expired on March 30, 2007, generic atorvastatin calcium tablets produced by Lek Pharmaceuticals and Zhejiang New Donggang were successively approved for market launch after 2009.
As of now, a total of four generic Atorvastatin Calcium Tablets in China have passed the consistency evaluation (Lek Pharmaceuticals’ Shanleting has not yet passed), while eight other enterprises (with joint applications counted as one) have submitted marketing applications for Atorvastatin Calcium Tablets.
Atorvastatin Calcium Tablets (Generic) That Have Passed the Consistency Evaluation
Atorvastatin Calcium Tablets (Generic) Under Review
2. Qilu Pharmaceutical Stirs Up the Domestic Lipid-Lowering Drug Market
Blood lipid levels in the Chinese population are rising steadily. Coupled with factors such as a large population base, accelerating aging, and increasing life expectancy, this has led to a growing number of patients with dyslipidemia in China, thereby driving up the demand for lipid-lowering drugs. According to an announcement by Lepu Medical, the market size for atorvastatin calcium tablets alone in China is nearly RMB 16 billion.
In addition to atorvastatin calcium, the fierce competition for bioequivalence evaluation of rosuvastatin is also in full swing. Currently, rosuvastatin calcium tablets from six manufacturers have passed the bioequivalence evaluation. More than ten companies are jointly vying for the statin lipid-lowering drug market.
Rosuvastatin Calcium Tablets (Generic) Passing the Consistency Evaluation
According to the data analysis results from Medicine Magic IPM, the domestic market for Atorvastatin Calcium Tablets in 2018 was nearly monopolized by two companies: Pfizer’s original Lipitor (73.64%) and Jialin Pharmaceutical’s Aole (23.90%). The market for Rosuvastatin Calcium Tablets was mainly dominated by AstraZeneca (67.25%), Lunan Better (16.93%), and Chia Tai Tianqing (7.28%).
Market Share of Atorvastatin Calcium Tablets
Market Share of Rosuvastatin Calcium Tablets
In the “4+7” City Volume-Based Procurement launched at the end of last year, Atorvastatin Calcium Tablets and Rosuvastatin Calcium Tablets were won by Jialin Pharmaceutical and Jingxin Pharmaceutical, respectively. The originator companies failed to win bids for these two products, which will directly lead to significant changes in the market share of statin lipid-lowering drugs in the “4+7” cities and even nationwide.
Although the new round of volume-based procurement has not yet officially launched and the policy landscape remains unclear, the fact that more capable manufacturers, including Qilu Pharmaceutical, have obtained bidding eligibility by passing the consistency evaluation will undoubtedly introduce further variables into the market dynamics of lipid-lowering drugs in China.