Pharmaceutical companies are actively engaged in the evaluation of generic drug consistency, and another company has successfully passed the evaluation at the start of May.
[Pharmaceutical Network Industry Dynamics] Compared to originator drugs, generic drugs have lower R&D costs and relatively more relaxed approval requirements for market entry. To promote the high-quality development of generic drugs, the Consistency Evaluation program for generic drugs has been introduced, serving as a prerequisite for centralized procurement. It is reported that since the implementation of the generic drug consistency evaluation policy, many pharmaceutical companies have actively participated in this initiative.
As we enter May, another pharmaceutical company has announced that its drug has successfully passed the bioequivalence evaluation for generic drugs. Specifically, on the afternoon of May 5, Lissheng Pharmaceutical Co., Ltd. announced that it recently received the "Notice of Approval for Supplementary Drug Application" issued by the National Medical Products Administration for Donepezil Hydrochloride Tablets 5mg, confirming that the drug has met the standards for quality and therapeutic equivalence in generic formulations.
Lisheng Pharmaceutical stated that the company's generic drug has passed the evaluation of quality and therapeutic equivalence, which will help enhance the product's market competitiveness.
According to available data, donepezil hydrochloride is a second-generation cholinesterase inhibitor, clinically used for the treatment of mild, moderate, or severe symptoms associated with Alzheimer's disease. It is currently believed that the pathogenesis of Alzheimer's dementia involves, in part, impaired cholinergic neurotransmission. Donepezil hydrochloride may exert its therapeutic effects by enhancing the function of cholinergic neurons. Specifically, it reversibly inhibits acetylcholinesterase, thereby preventing the hydrolysis of acetylcholine and increasing its concentration in the brain.
The Lissheng Pharmaceutical Donepezil Hydrochloride Tablets (trade name: Fusk) were approved for marketing in 2004. In 2019, Lissheng Pharmaceutical initiated the bioequivalence evaluation of its Donepezil Hydrochloride Tablets. Through detailed analysis of both the reference and generic formulations, the company redeveloped the generic product based on the reference formulation's prescription and manufacturing process. Key quality attributes were effectively controlled, and stability studies demonstrated that the product's in vitro characteristics were equivalent to those of the reference preparation.
In vivo evaluations included a single-center, open-label, balanced, randomized, single-dose, two-period, two-sequence crossover bioequivalence study conducted in healthy adult subjects under both fasting and postprandial conditions. The results indicated that the oral administration of the 5 mg Donepezil Hydrochloride Tablets from the test formulation exhibited bioequivalence compared to the reference preparation, regardless of whether administered under fasting or postprandial conditions.
It is understood that Lisheng Pharmaceutical is fully committed to advancing the consistency evaluation process. As of now, Lisheng Pharmaceutical has successfully completed the consistency evaluation for 12 product specifications, among which 3 are the first domestically approved.
The author has learned that several other pharmaceutical companies have recently had their drug products evaluated. For instance, Teiyi Pharmaceutical recently announced that it has received the "Drug Supplementary Application Approval Notice" for its "Aluminum Magnesium Carbonate Chewable Tablets," issued by the National Medical Products Administration after review. The company confirmed that the aforementioned drug has successfully passed the evaluation of quality and therapeutic equivalence with generic chemical drugs.
Jianyou Shares recently announced that the company has received from the National Medical Products Administration (NMPA) the "Notice of Approval for Supplementary Drug Application," confirming that its marketed enoxaparin sodium injection has successfully passed the bioequivalence evaluation for generic drugs.
Recently, Sinopharm Modern also announced that its wholly-owned subsidiary, Sinopharm Rongsheng, has received the "Notice of Approval for Supplementary Drug Application" issued by the National Medical Products Administration (NMPA), approving the injection-grade Acyclovir (0.25g) to have passed the evaluation of quality and therapeutic equivalence with generic drugs.
According to data statistics, a total of 144 approvals or deemed approvals for consistency evaluations were granted in April, covering 84 varieties from 93 companies. Among these, 16 varieties marked the first generics to pass the evaluation. In terms of companies that achieved approval, China Resources Double Crane, Sichuan Kelun, Yangtze River Pharmaceutical Group, Shijiazhuang No.4 Pharmaceutical, and CSPC Ouyi each had three varieties successfully evaluated in April.
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