On July 18, China National Joint Drug Procurement Office announced the official list of 327 products for the 7th volume-based procurement (VBP).
The 327 products are owned by 217 bid-winning companies, which will supply the products to public health institutions. Among the companies, 6 are international enterprises—Hetero Labs, Bracco Sine, Almirall, Sandoz, and Pfizer. Please refer to BaiPharm's previous report for their bid-winning products' detailed information, including prices.
Therapeutic Areas of the Bid-winning Products
The 327 products are classified into 60 categories based on the types and content ratios of active ingredients in finished dosage forms. Among the 60 categories,
12 categories are anti-infection medicines, such as Ornidazole Tablets, Clindamycin Phosphate Injection, and Roxithromycin Tablets;
3 categories are for hypertension;
3 for diabetes;
2 for non-small cell lung cancer.
Other drugs' indications include influenza, thrombosis, seizures, pancreatic cancer, thyroid cancer, etc.
Benefits and Limits of VBP
Basically, VBP is a program carried out by Chinese governments to make drugs affordable to more patients.
For pharmaceutical companies, VBP is a remarkable channel to sell drugs in bulk volumes. But due to lower unit prices, the profit from each sold product decreases.
Among the 60 bid-winning drugs in the 7th VBP, 56 are generics while only 4 are originators. This is mainly because generics have larger space for price reduction than innovator drugs, whose companies mostly tend to not slash prices due to their high R&D costs.
How to Bid for VBP
Firstly, China's National Joint Drug Procurement Office will announce the requirements for drug to apply for joining in the VBP. Usually, the qualified drugs are limited to
Originator drugs or reference listed drugs;
Generic drugs that have passed the quality and therapeutic equivalence evaluation;
In the marketing authorization applications, generic drugs that have proven they are equivalent with the originator drugs / reference listed drugs in quality and efficacy.
These drugs are required to have obtained marketing authorization before a specific date. For example, drugs applying for joining the 7th VBP should have marketing authorization licenses issued no later than July 7, 2022.
Companies need to prepare the following documents:
Commitment letter on VBP application;
Letter of authorization from the legal person;
The application information form (sealed in an independent package);
Document proving that the drug is qualified for the VBP application;
The company's qualification documents (only one set of documents is required if the company has multiple drugs applying for joining in the VBP)
Document specifying that the active pharmaceutical ingredient (API) is produced by the finished dosage form manufacturer itself (a copy of the drug registration certificate is required when the API manufacturer and the finished dosage form manufacturer share the same legal person);
Commitment letter on production capacity.
The companies should first register at the Office's procurement service platform and later send representatives with the application documents to the bid site on the designated day. The preliminary and final bid results will be announced by the Office on its website.
Articles on VBPs:
