New Batch of Generic Drug Reference Listed Products Announced: 54 Varieties Included

　　【Pharmaceutical Network Industry DynamicsOn February 15, 2022, the National Medical Products Administration (NMPA) issued the announcement on the publication of the 51st batch of reference listed drugs for generic drugs (Announcement No. 9 of 2022).
 

According to the 51st List of Reference Preparations for Generic Drugs, a total of 54 drugs are included. Products from several large pharmaceutical companies such as Novartis, AbbVie, and Pfizer are on the list of reference preparations for generic drugs.
 

Among the 54 drugs, including six original research drugs marketed in China such as Sodium Cefpirome Sulfate for Injection, Loteprednol Etabonate and Tobramycin Eye Drops, and 37 unimported original research drugs such as Anidulafungin for Injection, Deferasirox Granules, Upadacitinib Extended-Release Tablets, Lanreotide Acetate Extended-Release Injection (Pre-filled), Roxatidine Acetate Hydrochloride Extended-Release Granules, and Pediatric Cefalexin Compound Granules.
 

The author learned that among the six original research drugs listed in China, there are some varieties that have drawn much attention within the industry and are relatively familiar, such as Basilea's Cefpirome Sodium for Injection.
 

This variety is a formulation for intravenous injection.Cephalosporins, jointly developed by Basilea and Johnson & Johnson, exhibits rapid and broad-spectrum antibacterial activity. It inhibits a variety of Gram-negative and Gram-positive bacteria, including methicillin-sensitive Staphylococcus aureus (MSSA), methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-intermediate Staphylococcus aureus (VISA), and vancomycin-resistant Staphylococcus aureus (VRSA), among other pathogens. It is mainly used to treat community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP) in adult patients but does not include ventilator-associated pneumonia (VAP).
 

According to the data, on September 28, 2017, Shenzhen CR Nine New Pharmaceutical Co., Ltd. signed a technical licensing agreement with Basilea for ceftobiprole. The agreement stipulates that CR Nine New Pharmaceutical possesses the development, production, and commercialization license for the fifth-generation cephalosporin ceftobiprole in mainland China, Hong Kong, and Macao. It is reported that this product has been approved for marketing in the EU, Australia, China, and other countries or regions for the treatment of adult hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP) and community-acquired bacterial pneumonia (CABP).
 

The document notes that selecting non-imported reference products for generic drug research must meet their quality requirements as well as the requirements of the current edition of the Chinese Pharmacopoeia and relevant guidelines. Additionally, after the reference product list is announced, varieties not yet officially published will undergo special research, and further announcements will be made based on the research results.
 

According to the public information from the National Medical Products Administration, since the beginning of this year, two rounds of the generic drug reference formulation directory have been announced. On January 7, 2022, the 50th batch of the generic drug reference formulation directory was released, including a total of 70 varieties. According to incomplete industry statistics, so far, all 51 batches of the directory have cumulatively released 4,858 reference formulations.
 

Reference Listed Drug (RLD) refers to the control drug used for the development of generic drugs, which is one of the key factors in the research and development process of generic drugs. It is also an important condition for effectively carrying out the development of generic drugs and conducting consistency evaluation work. It is reported that since 2016, China has cumulatively released 51 batches of directories of reference listed drugs for chemical generic drugs. The issuance and implementation of relevant policies and directories for the selection of reference listed drugs for chemical generic drugs have effectively promoted the progress of China's consistency evaluation work for chemical generic drugs, and laid a solid foundation for the scientific regulation of drug safety and efficacy.
 

　　Disclaimer:In no event shall the information or opinions expressed in this article constitute investment advice to any person.