CHINA — China has banned the import and sale of GSK’s Avodart (dutasteride) soft capsules through its national bulk-buy drug procurement program effective immediately and will last until April 2024.
The drug is used in combination with Boehringer Ingelheim’s Flomax for enlarged prostate.
The ban was prompted by an inspection of a plant in Poznan, Poland, which revealed that the company did not perform batch-by-batch and full-item inspections of products shipped to China.
The National Medical Products Administration determined that the company could not prevent and control potential microbial contamination without proper inspection. The practices were in violation of China’s good manufacturing practice (GMP) standards.
GSK purchased the Polish site in 1998 and, according to a 2018 report, spent approximately US$500 million there over a 20-year period, producing 8.7 million tablets and 1.3 million capsules daily for 130 countries.
The drugmaker announced plans for a financial hub in Poznan in March 2019, which will remain in GSK’s hands going forward, according to a release.
No other GSK products are supplied to China through the so-called volume-based procurement (VBP) program, according to a company’s spokesperson.
Avodart made around 300,000 pounds (US$345,900) per year of sales in China, accounting for less than 1% of GSK’s total sales in the country, according to company figures.
Beijing runs a national scheme aimed at encouraging the uptake of generic drugs and bringing down the cost of medicines. As part of the program, drugmakers vie to sell their products in bulk at public hospitals.
The exclusion from the VBP program represents a setback for GSK, which considers China – one of the biggest markets for biopharmaceuticals worldwide.
GSK reported double-digit sales growth in China, which it described as a priority market in its 2021 annual report.
However, much of that ambition is tied up in sales of its branded medicines. For instance, when GSK detailed plans in 2021 for its future as a standalone pharmaceuticals business following the spin-off of its consumer health arm, the company said it was banking on volume demand for products like its shingles vaccine Shingrix to increase in China as well as the United States.
In separate but positive news GSK aims to deliver first respiratory syncytial virus (RSV) vaccine after positive Phase III results, a boost for the pharmaceutical company after falling behind in its quest to develop a Covid shot.
RSV causes a respiratory tract infection that affects 64 million people per year worldwide. It hospitalizes 3 million children under 5 years old and approximately 336,000 older adults annually.
The vaccine against RSV, outperformed its primary goal in the study without causing any safety concerns, becoming the first to demonstrate significant efficacy in adults over the age of 60.
The findings mark a watershed moment in the search for an RSV vaccine, which has eluded scientists for decades.
Other pharmaceutical companies, including Pfizer Inc. and Johnson & Johnson, are also developing anti-viral vaccines, which could represent a multibillion-dollar market opportunity.
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