Nuggets: Is the product that failed the reference preparation a point of opportunity?

According to the current national centralized procurement rules and provincial centralized procurement rules, the national centralized procurement rules target chemical drugs that have passed the consistency evaluation and biosimilar drugs that have completed clinical research on the market

There are mainly two types of products under the provincial centralized procurement rules.

Generic drugs must first have a reference preparation to declare consistency evaluation.

Recently, CDE has released a list of products that have not passed the reference preparation.

It is worth noting that the reference preparation of oxaliplatin for injection previously announced by the state is the original Sanofi, because "after the review of the consistency evaluation expert committee, it is planned to transfer the reference preparation due to the oxalid prepared by the terminal sterilization process.

Oxaliplatin for injection is mainly sold in hospital terminals.

What is more ambiguous about the policy now is the National Bureau’s standard for “if one company passes the consistency evaluation, it must complete the consistency evaluation within three years, otherwise it will not be re-registered”.

If the products on the list of products that failed the reference preparations are not listed in the country, it means that there is no opportunity for imitations to be marketed in the future

As analyzed above, a product with the same route of administration and the same generic name without a reference preparation is like having a "freedom-free gold medal" and can continue to lie down for a longer period of time

This article will focus on selecting three products that failed the reference formulations issued by CDE:

Acarbose Chewable Tablets

Market potential: more than 500 million yuan

Listed manufacturers: Hangzhou Zhongmei East China

The reason for the rejection of the reference preparation: After the deliberations of the Consistency Evaluation Expert Committee, this product is a modified dosage form, and there is no such dosage form in the original research

Market value: The biggest risk lies in the provincial centralized procurement renewal group, whether it will compare the price with ordinary tablets

Metronidazole vaginal gel

Market potential: over 100 million yuan

Listed manufacturer: Tongfang Pharmaceutical

Reasons for refusal of the reference preparation: After review by the Consistency Evaluation Expert Committee, the proposed reference preparation is a generic drug marketed in the United States and does not have the status of a reference preparation.

Market value: National centralized procurement products are oral solid preparations, vaginal gel is not an oral medication, and the price is not affected by centralized procurement

Acetylcysteine ​​injection

Market potential: over 100 million yuan

Listed manufacturers: Hangzhou Minsheng, Shanxi Guorun, Ruiyang Pharmaceutical

Reasons for rejection of the reference preparation: After review by the Consistency Evaluation Expert Committee, complete and sufficient safety and efficacy data were not provided, and the review was not passed

Market value: There is no need to pass the consistency evaluation, and the products of listed manufacturers can continue to maintain the existing market and price, unless they enter the provincial centralized procurement for price wars

The above three products are all good products from the current policy.