China CDE Drafts Guideline for Subject Selection in Antitumor Drug BE and PK Studies

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration has released the “Considerations for Subject Selection in Bioequivalence and Pharmacokinetic Ratio Studies of Antitumor Drugs (Draft for Comments)” for public consultation, with a deadline for feedback set on June 6, 2025. This draft outlines proposed regulatory expectations for selecting subjects in clinical studies of biosimilar and antitumor drugs, with a focus on ensuring data reliability and ethical compliance. International stakeholders involved in biosimilar development or conducting BE/PK studies in China are advised to review the draft and assess its potential implications for ongoing or planned trials.

Core Content and Key Considerations

Basic Principles for Subject Selection: The draft emphasizes that the selection of subjects for BE and PK ratio studies of antitumor drugs should be based on the following principles: Scientific Rationality (the study design should accurately reflect the biological equivalence or PK characteristics of the drug), Subject Safety (prioritize the protection of subject rights and avoid unnecessary risks), and Operability (optimize the feasibility of the trial while meeting scientific and ethical requirements).
Applicable Situations for Healthy Subjects vs. Cancer Patients:Potential applicable conditions for healthy subjects:
1. Applicable to low-toxicity, non-cytotoxic antitumor drugs (such as some hormone drugs, small molecule targeted drugs).
2. Need to optimize dosage (such as microdosing trials) or strict safety monitoring to reduce risks.
3. May require sufficient preclinical data to support the rationality of using healthy subjects.
Prioritizable situations for cancer patients:
1. High-risk drugs (such as chemotherapy drugs, immune checkpoint inhibitors).
2. Biosimilar PK ratio studies to ensure consistency with the originator drug in real patients.
Special Considerations for Biosimilar PK Studies:
1. Representativeness of patient populations: Whether to select specific tumor types (such as breast cancer, lung cancer) or disease stages (such as stable phase patients) to reduce variability.
2. Optimization of study design: Such as using crossover design or population pharmacokinetic (PopPK) analysis to improve data reliability.
Ethical and Regulatory Requirements:
1. Informed Consent: Ensure that subjects (especially cancer patients) fully understand the trial risks and rights.
2. Independent Ethical Review: The study protocol must be strictly evaluated by an ethics committee.
3. Risk Minimization Measures: Such as establishing a safety monitoring committee (DSMB) to dynamically assess the safety of the trial.

The CDE will summarize and analyze the suggestions from all parties after the collection of comments and revise the guideline content accordingly. The final version of the document is expected to be released within 2025, which will provide clear regulatory requirements for BE and PK studies of antitumor drugs.

Further Information

To read the original announcement about the draft guidance on subject selection in BE and PK studies of antitumor drugs released by the Center for Drug Evaluation (CDE), please click here.

If you are a pharmaceutical company conducting BE or PK studies for antitumor or biosimilar drugs and have questions about regulatory requirements in China, please contact Cisema.