On September 29, 2024, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) published the “Draft Technical Guidelines for the Preparation of Biosimilar Drug Labels” for public consultation. The document aims to provide detailed technical requirements for the writing of biosimilar drug labels, offering guidance to physicians and patients on medication choices, safety monitoring, and risk control. The public consultation period is set for one month from the date of publication.
Since 2015, China has issued several guidance documents in the field of biosimilar drugs, including the “Interim Technical Guidelines for the Research and Evaluation of Biosimilar Drugs,” “Technical Guidelines for the Evaluation of Biosimilarity and Extrapolation of Indications,” “Guidelines for the Naming of Biological Products,” and “Q&A on Issues Related to the Research and Development of Biosimilar Drugs.” These documents have provided principle-based suggestions on the writing of biosimilar drug labels, but detailed standards have not yet been formalized.
The content of biosimilar drug labels should fully reflect the safety and efficacy information of the reference drug. The safety and efficacy information in the reference drug’s label can provide the necessary scientific information required by medical professionals and patients, assisting them in making clinical medication decisions based on recommendations for indications and dosing regimens in the label. Therefore, it is recommended to include relevant information from the reference drug’s label in the biosimilar drug label, with appropriate modifications to aid in clinical medication decisions, ensuring the safety and efficacy of drug use and reducing potential medication errors.
Information from studies conducted to support the demonstration of biosimilarity is generally not included in the biosimilar drug label, unless necessary. For instance, if the clinical data helps medical professionals and patients to safely and effectively use the biosimilar drug, then the biosimilar drug’s clinical trial information and data may be considered for inclusion in its label. The inclusion of relevant data and information from the reference drug’s label in the biosimilar drug label should be tailored according to whether the biosimilar drug is applying for all or fewer than the reference drug’s approved indications (such as indications, dosing regimens), with appropriate modifications to these information. Given the special nature of biosimilar drugs, it should be clearly identified as a biosimilar drug in a conspicuous location on the label.- Flcube.com
