Biosimilars & Biologics
Key legal info on biosimilars & biologics in China. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for GBP 99.
1. Are biosimilar medicines considered the same as generic medicines in your country?
The basic principles of research and evaluation of biosimilar medicines are similar to that of generic medicines, but the regulation in practice is different. Biosimilar medicines are included in the category of biologics for the purpose of regulation.
2. Are all biologic medicines, including biosimilar medicines patentable in your country?
There is no specific legal restriction on the patentability of biologic medicines. As long as biologic medicines meet the requirements for a patent, they can be registered.
3. Is there a specific regulatory framework for the marketing authorization of biosimilar medicines in your country? If yes, what is the regulatory framework for the authorization of biosimilar medicines?
The NMPA promulgated the Technical Guidelines for Research and Development and Evaluation of Biosimilars in 2015. Generally, there is no specific regulatory framework for the marketing authorization of biosimilar medicines in China.
4. What kind of data package is needed to obtain approval for a biosimilar drug? Is this any different to the requirements for the original Biologics drug?
The research and development of a biosimilar drug is based on the similarity study between the biosimilar and original biologics drug, which supports the safety, effectiveness and quality control of the biosimilar drug.
In addition, in practice, the Centre for Drug Evaluation (hereinafter referred to as the “CDE”) of the NMPA suggests the sponsor collect the immunogenicity data of all subjects in all clinical studies (including human PK or PD studies). Reasonable sampling time and the follow-up period should be set according to the immunogenicity characteristics of different products. The duration of any treatment course, pharmacokinetic characteristics of preparations and the occurrence time of the humoral immune response should be taken into account. The CDE suggests the sponsor may discuss with CDE case by case. Attention should also be paid to any difference of immune response between biosimilar and the original biologics drug, and the causes of the difference and their impact on the effectiveness and safety should be analysed.
5. What are the requirements for the choice of the reference comparator product?
Please refer to Question 6.
6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?
According to an academic paper written by a team of the CDE, the reference comparator product should be the original biologics drug which has obtained the PRC marketing authorization, and products from the same origin should try be used as the reference comparator product in each stage of research and development. For those that cannot be obtained in China through commercial channels, other appropriate channels can be considered, but bridging comparative studies of the reference comparator product from different sources are required, or comparable evidence between reference comparator products from different sources should be provided.
In addition, the original biologics drug which has been approved for import registration or clinical trials in China should be selected as the reference comparator product for clinical trials of biosimilars. Only after the consent of the CDE, can the original biologics drug from the place of origin which has not been approved be used for clinical trials. The reference comparator product selected for the comparative study of similarity in each stage of research and development should be the product from the same origin.
7. How are the prices of biosimilar medicines regulated? Is this any different to the requirements for the original Biologics drug?
There is no regulation on the pricing of biosimilar medicines in China and there are no difference from the requirements for the original biologics drug.
8. What is the reimbursement policy for biosimilar medicine? Is this any different to the requirements for the original Biologics drug?
Once the biosimilar medicines are included in Drug Catalogue (as defined in Question 7, Chapter: Orphan Drugs and Rare Diseases), the prices of biosimilar medicines can be reimbursed (mostly) and covered by national medical insurance.
This is not different from the requirements for the original Biologics drug.
9. Does biosimilar competition impact the reimbursement policy of the originator reference products?
10. What is the legal framework for biosimilar medicines prescribing (clinical decision maker) and dispensing (pharmacy level, hospital or retail)? Is this any different to the requirements for the original Biologics drug?
There is no legal framework for prescribing and dispensing biosimilar medicines.
11. Is the system considering physician-led switching and/or pharmacy-level substitution (without involvement of the clinical decision maker)?
Physician-led switching applies.
12. What are the post – authorisation requirements (including pharmacovigilance, risk management plans, post-approval studies) for biosimilar medicines? Is this any different to the requirements for the original Biologics drug?
Currently, there are no such specific requirements for biosimilar medicines.
13. Are there specific policies and requirements in terms of biosimilar medicines labelling in the event of second medical use patents? Is this any different to the requirements for the original Biologics drug?
According to the academic paper written by a team of the CDE, the labelling of biosimilar medicines should not affect the clinical use and should be conducive to the safety monitoring after marketing.
In practice, at present, it is advisable to add such description in the header of the first page of the package insert as “The biosimilar medicine (XXX) refers to the biosimilar drug of the reference comparator product (XXX)”; to add the definition of “biosimilar medicine” at the bottom of the first page: “Biosimilar medicine means the data supporting the marketing authorization of this biological product has proved that this biological product is highly similar to the reference comparator product approved by the NMPA, and there is no difference in clinical significance. This package insert is consistent with that of the original biologic drug.”
The clinical trial data in the package insert of biosimilar medicines should reflect the effectiveness and safety, not the similarity. As to the use of names of biosimilar medicines in the package insert, it is necessary to differentiate from the name of reference comparator product, the name of similar drug and the generic name. When quoting the clinical research data of reference comparator product, it is advisable to use the generic name of the reference comparator product instead of the brand name.
14. Have there been any significant legal/judicial developments in relation to biosimilars in your country? (Including but not limited to IP, procurement, competition, misleading information campaign, access to reference comparator product)
The significant legal development is that in order to improve the accessibility of biosimilars to meet the needs of patents, more and more regulations and guidelines on research and development of biosimilars have been promulgated.
15. Are there proposals for reform or significant change to the legal, regulatory, procurement of biosimilars? If yes, when are they likely to come into force?
The draft of the Technical Guidelines for Similarity Evaluation and Indication Extrapolation of Biosimilar Drugs (生物类似药相似性评价和适应症外推技术指导原则) has been issued for comments. After the comment stage ends, the Guidelines are likely to be promulgated and come into force soon.