IGBA Biosimilars Committee Positions
IGBA member companies are the pioneers and global leaders in the development and marketing of biosimilar medicines. The objectives of the IGBA Biosimilars Committee shall be to represent, support and develop, where appropriate and necessary, the common scientific and technical interests of the biosimilar medicines industry, members of IGBA. One of the key objectives is promoting and supporting globally the scientific concept of biosimilarity.
- IGBA identifies streamlined development through reduced comparative clinical studies and appropriate use of global comparator product as key to greater biosimilar access (July 2024)
- IGBA position on Streamlined Development (April 2024)
- In Support of Global Comparator for Biosimilars. Waiving bridging studies concerning local versus global reference products (August 2023)
- IGBA Biosimilars Committee White Paper "Embracing Science with Confidence: Adopting the Revised 2022 WHO Biosimilars Guideline" (November 2022)
- Webinar - Unlocking the Global Biosimilar Opportunity in Tackling NCDs (webinar recording - November 2021)
- IGBA Biosimilars Committee White Paper "A Biosimilar medicines Access Policy Blueprint" (October 2021)
- IGBA Reflection Paper – Challenges and Opportunities for Access to Biosimilar Insulins and Analogs (August 2021)
- IGBA Applauds UK MHRA Biosimilar Guidance Revision: Science-driven Evolution for Sustainable Access to Biologics (May 2021)
- IGBA Policy Paper: Developing a Regulatory Policy Framework Supporting Biosimilar Competition: The Opportunity for Tailored Clinical Biosimilar Development (September 2020).
- IGBA Peer-Reviewed Scientific Paper on “The Path Towards a Tailored Clinical Biosimilar Development" (07 April 2020)
- IGBA Presentation on The Importance of Global Regulatory Harmonization for Biosimilar Medicines (November 2019)
- IGBA Position on Identification of Biological, including Biosimilar Medicines 2019 Update of Facts & Figures (June 2019)
- IGBA Comments on the FDA’s Nonproprietary Naming of Biological Products: Update (May 2019)
- IGBA Contribution: Pricing implications of policies on biosimilar cancer medicines (April 2019)
- IGBA Reflection on Regulatory System Strengthening for Biosimilar Medicines (March 2019)
- IGBA presentation on Global Comparator Product and waiving of bridging studies (March 2019)
- IGBA Comments on FDAs Questions and Answers on Biosimilar Development and the BPCI Act (Revision 1) (February 2019)
- IGBA Reflection Paper on waiving bridging studies for biosimilar medicines applications (September 2018)
- IGBA submission to HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs [RIN 0991-ZA49]
- Communication slide deck on biosimilar medicines
- IGBA position on regional naming developments (October 2017)
- IGBA comments to TGA's Consultation: Naming of Biological Medicines (September 2017)
- IGBA commentary on FDA’s Draft Guidance on Labeling for Biosimilar Products (June 2016)
- IGBA calls for full transparency and new timelines for impact assessment with regard to the voluntary WHO biological qualifier (BQ) proposal (March 2016)
- IGBA letter to FDA regarding their biologics naming proposals (November 2015)
- IGPA Letter Regarding TGA Guidance titled “Evaluation of Biosimilars"(September 2013)
