The National Medical Products Administration (NMPA) has decided to suspend the import, sales, and use of GlaxoSmithKline’s (GSK, NYSE: GSK) Avodart (dutasteride) in China. The drug had previously won a spot during the fifth round of volume-based procurement (VBP). However, recent overseas non-on-site inspections revealed that not all batches of the drug exported to China were inspected in accordance with filing standards. Additionally, the inspections found insufficient prevention and control of microbial contamination risks.
Regulatory Actions and Consequences
On the same day, the national drug alliance procurement office released a notification indicating that Avodart was stripped of its VBP winning status. GSK was also added to the violations list, meaning the UK company will be ineligible for VBP filing from October 31, 2022, to April 29, 2024. The procurement cycle for the drug ended at the end of October, and no substitute procedure will be initiated.
Background on Avodart
Avodart was first approved in the US in November 2001 and was granted import approval in China in April 2011. The drug is used to treat urinary retention and prostatic hyperplasia by reducing the volume of the prostate and improving lower urinary tract symptoms. It works by inhibiting the transformation of testosterone to dihydrotestosterone (DHT) and reducing DHT levels in the prostate. In China, domestic companies such as Guowei Pharma, Hengrui Medicine, and Qilu Pharma are also approved to manufacture the product. Both GSK and Hengrui Medicine won spots for the drug during the fifth VBP round.-Fineline Info & Tech
