The Biosimilars Working Group (BWG) provides meaningful outcome to promote public health through more affordable biosimilar products.
Mandate
1. General considerations
The expiration of patent of original biological products enables the regulatory pathway for follow-on biological products, which were produced to be similar to already licensed original products. EMA was a pioneer for establishing legislation and guidelines from 2005 and called the product according to this process ‘biosimilar’. Japan, Canada, Korea as well as WHO published their guidelines for biosimilar product.
Many biosimilar products are already licensed in many countries. As a result of the experience for last 7 ~ 8 years, necessity for regulatory convergence arose due to the global development trend of biosimilars. In the ICH meeting held in Osaka, 2013, it was agreed to establish an IPRF Working Group on Biosimilar products to discuss emerging issues and to promote regulatory convergence.
Biosimilars are biotherapeutic products that are generally composed of complex biological substances, which may demonstrate a degree of variability (e.g. microheterogeneity). This variability is may be the potential challenge to develop a highly similar (biosimilar) version of the biological medicine since they are relatively new and further experience needed to be gained in the global environment.
In these circumstances, the need for discussion group for regulatory issues has been increased to promote convergence of review and regulation of biosimilar products. The IPRF biosimilar working group will contribute to provide meaningful outcome to promote public health through more affordable biosimilar products.
2. Objectives
- For regulatory convergence of technical requirements for biosimilar products in facilitating the regulatory process
- To support international regulators develop safe and effective regulatory frameworks for biosimilar products
3. Scope
- To discuss regulatory challenges and potential topics/areas for harmonization or convergence regarding biosimilars
- To consider how regulatory convergence can be achieved and how regulatory information can be exchanged without compromising confidentiality
- To explore work sharing process with other international bodies and to collaborate in terms of training of international regulators
4. Composition
The working group is comprised of international regulatory authorities.
5. Rules of procedure
a. Responsibilities and term of chairperson
- To develop a draft longer-term plan of discussion topics
- To draft agendas for each meeting
- To facilitate and conduct the Forum face-to-face meetings
- To organize periodic teleconferences, and/or videoconferences, and to lead the group in making progress on topics or sunsetting those topics in which progress cannot be made
- A co-chair will also be appointed from the membership, for the same renewable terms lengthe, and will assist the Chair, sharing the management workload and helping maintain progress on the work indertaken by the Forum.
b. Organization of meetings and reporting arrangements
- Biosimilar WG will meet every 3~4 month from end of March via teleconference
- The Chair will organize the teleconference by providing multi-connecting phone and pin number
- The Chair will draft agenda and circulate to members at least one week before teleconference (Co-chair to assist)
- The Chair and co-chair will facilitate teleconference to make conclusion, action points, next steps
- The co-chair will draft meeting minute for circulation
- The chair will circulate meeting minute and take comments from members to finalize it.
6. Deliverables
See Work Plan.
Please find the main deliverables here (click to go to the page):
- Reflection Paper on Extrapolation of Indications in Authorisation of Biosimilar Products
- Training Manual on the Basics of Analytical Comparability of Biosimilar Monoclonal Antibodies (English, Spanish, Russian)
- Nonclinical Comparability Exercise of Biosimilar Monoclonal Antibody for Regulatory Reviewers
- Training Manual on the Basics of the Clinical Comparability Exercise for Biosimilar Monoclonal Antibodies
Please find a knowledge base on Biosimilars here (click to go to the page):
- Principles of Biosimilars Approach
- NRA Regulations and Guidelines
- NRA Biosimilar Q&A Resources
- NRA Biosimilar Review Report