Qilu Pharmaceutical's Ibandronate Sodium Injection, a Nearly RMB 1 Billion Market Product, Receives Approval for Generic Drug Consistency Evaluation

Highlights

On August 5, the official website of the National Medical Products Administration (NMPA) indicated that Qilu Pharmaceutical's Ibandronate Sodium Injection was approved via a supplemental application to pass the quality and efficacy consistency evaluation, making it the second company to pass the evaluation for this product. Data from Menet shows that in recent years, sales of Ibandronate Sodium Injection at the terminal end of China's public medical institutions have grown rapidly, approaching nearly RMB 1 billion in 2020. Among them, Hebei Medical University Biotech holds the largest market share, exceeding 30%, with Chengdu Yondon Biopharmaceutical closely trailing in second place.

Notice on the Release of Information Regarding Drug Approval Certificates Ready for Collection on August 5, 2021

Data indicate that ibandronate sodium is a third-generation bisphosphonate developed by the Swiss pharmaceutical company Roche. The injectable formulation was first approved in the European Union in June 1996 for the treatment of hypercalcemia of malignancy and the prevention of skeletal-related events (pathological fractures, and bone complications requiring radiotherapy or surgery) in patients with bone metastases from breast cancer.

Sales of Ibandronate Sodium Injection at the Terminal of Public Medical Institutions in China in Recent Years (Unit: RMB 100 Million)

Source: Competitive Landscape of China's Public Medical Institution Terminal

Data from Menet indicates that terminal sales of ibandronate sodium injection at China's urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (collectively referred to as China's public medical institutions) have grown rapidly in recent years, reaching nearly 1 billion RMB in 2020. Among the manufacturers, Hebei Medical University Biological holds the largest market share at over 30%, followed closely by Chengdu Yuandong Biological Pharmaceutical in second place.

Review Status of Supplemental Application for Consistency Evaluation of Ibandronate Sodium Injection

Source: MENET MED2.0 China Drug Evaluation Database

There are nine manufacturers of Ibandronate Sodium Injection in China, including Chengdu Yuandong Biopharmaceutical, Qilu Pharmaceutical, Tianjin Hongri Pharmaceutical, and Sichuan Meidakang Jiale Pharmaceutical. In March this year, Chengdu Yuandong Biopharmaceutical became the first company to pass the consistency evaluation for Ibandronate Sodium Injection. With this recent approval, Qilu Pharmaceutical has become the second manufacturer to pass the consistency evaluation for this product. Currently, the supplemental application for consistency evaluation submitted by Nanjing Hengsheng Pharmaceutical for Ibandronate Sodium Injection remains under regulatory review.

Source: Official website of the National Medical Products Administration, Menet Database