Unlike small molecule drugs, biologics have complex structures and therefore require a strong understanding of analytical techniques and equipment that is required for demonstrating the critical structural attributes of the biosimilar, as well as sensitive methods for demonstrating product purity.
TORONTO (PRWEB)
March 02, 2023
Biological medicines have had a tremendous impact on the treatment of medical conditions, such as diabetes, Crohn’s disease, various forms of cancers and more. As these innovator drugs come off patent, the production of “generic” biologics, or biosimilars, has increased as a means to allow these critical medicines to be more widely accessible to the public and at a reduced cost compared to the original product. In this webinar, the featured speakers will dive into the importance of establishing biosimilarity and take attendees through the analytical techniques to confirm sameness.
Unlike small molecule drugs, biologics have complex structures and therefore require a strong understanding of analytical techniques and equipment that is required for demonstrating the critical structural attributes of the biosimilar, as well as sensitive methods for demonstrating product purity. Furthermore, most regulatory authorities also require orthogonal approaches to demonstrate similarity of critical quality attributes which requires specialized knowledge, as well as additional time and resources.
This webinar will cover key aspects to consider when conducting a sameness program, including: An introduction to the regulatory scope for biosimilarity submission packages; Similarity assessment (Biosimilarity): Head-to-head comparison for safety, purity, structure and potency; Identifying techniques which can report on critical quality attributes; Showcasing techniques utilized for showing product sameness, including strengths and weaknesses of different techniques; And analytical challenges unique to peptides.
During this webinar, the speakers will also highlight important attributes to consider when planning and developing a biosimilarity program to help in choosing the right CRO for the sameness package and achieving a successful filing.
Register today to learn more about the analytical strategies for biosimilarity and sameness testing to fulfill FDA submission requirements.
Join Megan Bergauff, PhD, Principal Scientist, Biologics and Small Molecule Mass Spectrometry Team Leader, SGS Health Science – West Chester; Rebecca Strawn, PhD, Principal Scientist, Biophysical and Physicochemical Team Leader, SGS Health Science – West Chester; and Robert T. Cartee, PhD, Senior Director, Biopharmaceutical Services NAM, SGS Health Science – Fairfield, for the live webinar on Thursday, March 23, 2023, at 12pm EDT (9am PDT).
For more information, or to register for this event, visit Biosimilarity and Sameness Testing: Analytical Strategies to Fulfill FDA Submission Requirements.
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