Biosimilars offer cost-effective alternatives to approved biologic drugs. These biotherapeutics are derived from living organisms, with no clinically meaningful differences from the original biologic drugs used, for instance, in oncology or autoimmune diseases. Their access to the pharmaceutical market must be supported by a rigorous development process, ensuring safety, efficacy and regulatory compliance.
In this webinar, a comprehensive overview of biosimilars will be provided, exploring their growth in the pharmaceutical market and the challenges manufacturers face in ensuring comparability, quality and market approval.
Robust physicochemical and functional characterization provides crucial insight on the substances’ behavior under different conditions and will contribute to comprehensive comparability studies. Analytical approaches to characterization will be discussed, as well as chemistry, manufacturing and controls (CMC) considerations for product release, forced degradation and stability assessment. Expert presenters Luc-Alain Savoy, Fouad Ouasti and Sahil Shah will examine safety, identity, strength, purity and quality (SISPQ) considerations for biosimilar product development.
For manufacturers looking to understand the challenges of biosimilar development, this webinar presents a unique opportunity to gain expert insights.
Agenda
- Introduction to biosimilars
- Physicochemical characterization – the foundation of biosimilarity demonstration
- Functional characterization – a critical step in biosimilar development
- Method implementation for quality control (QC) and release
Who should attend:
This webinar will be of interest to biopharma professionals involved in the development, manufacturing and market approval of biosimilars, including research and development (R&D) scientists, bioprocess development specialists, analytical chemists, biotechnologists and quality assurance/control (QA/QC) teams.
This event takes place on May 19, 2025, at 2:00 pm GMT.