Biosimilarity and Sameness Testing: Analytical Strategies to Fulfill FDA Submission Requirements

Life Sciences, Pharma Manufacturing & Supply Chain, Biosimilars,
  • Thursday, March 23, 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 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.


With more than 600 approved biosimilars for 45 innovator products in 50 countries on the market today, the biosimilar market was valued at $13B in 2021 and is expected to increase to $60.8B by 2027, driven mainly by the expiration of patents of blockbuster biopharmaceuticals.

Since creators of biosimilars often use a different manufacturing process than that of the innovator product, biosimilars must be confirmed to have the same quality as the original product. Although each country has unique regulations for the approval of biosimilar products, all regulations, including the US Food and Drug Administration (FDA), require a demonstration of similarity to the innovator product by extensive structural and functional characterization. The degree of similarity and product quality dictates the scope and breadth of preclinical and clinical evaluation which, in turn, impacts the cost of the biosimilar product.

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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
  • 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.


Megan Bergauff, SGS Health Science – West Chester

Megan Bergauff, PhD, Principal Scientist, Biologics and Small Molecule Mass Spectrometry Team Leader, SGS Health Science – West Chester

With more than 13 years of experience with mass spectrometry, including nearly 11 years with SGS in pharmaceutical/biopharmaceutical characterization, Dr. Megan Bergauff serves as the Team Leader for the Small Molecule and Biologics Mass Spec Teams at SGS’s Philadelphia site. Her area of expertise focuses on method development for mass spectrometric analysis of peptides and small molecules. Dr. Bergauff has additional expertise covering a wide range of applications, including those for determination of process residuals, impurities, enantiomeric purity and extractables/leachables, using LC-MS and GC-MS. Dr. Bergauff earned a PhD from the University of Montana in analytical chemistry and a bachelor’s degree in biology and chemistry from Butler University.

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Rebecca Strawn, SGS Health Science – West Chester

Rebecca Strawn, PhD, Principal Scientist, Biophysical and Physicochemical Team Leader, SGS Health Science – West Chester

As the Team Leader for the Biophysical and Physicochemical Teams at SGS’s Philadelphia site, Dr. Rebecca Strawn lends 12 years of pharm/biopharm experience, including eight years with SGS to helping clients develop and characterize drug products. Her areas of expertise range from ligand binding theory and allostery, protein-protein interactions (self-assembly), protein production and purification, to all standard biophysical methodologies for assessing HOS and thermodynamics of proteins and peptides, to full in silico computation. Dr. Strawn earned a bachelor’s degree in chemistry from Shippensburg University and a PhD from Princeton University in biophysics.

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Robert T. Cartee, SGS Health Science – Fairfield

Robert T. Cartee, PhD, Senior Director, Biopharmaceutical Services NAM, SGS Health Science – Fairfield

With 13 years of experience in the development of biopharmaceuticals, Dr. Robert T. Cartee provides strategic and technical guidance for analytical testing in his role as Senior Director of Biopharmaceutical Services for North America at SGS.

Dr. Cartee also has extensive experience in the development of biopharmaceutical manufacturing processes and assay and formulation development, including 12 years leading the development of protein and polysaccharide-based vaccines against bacterial pathogens. Dr. Cartee received a doctoral degree from the University of Alabama at Birmingham (UAB) and a bachelor’s degree in molecular biology from Auburn University.

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Who Should Attend?

  • Biotech leaders/companies looking to outsource sameness testing for abbreviated new drug application (ANDA)/biosimilar submissions
  • Scientists looking to understand more about biosimilarity testing, techniques and technical challenges

What You Will Learn

Attendees will gain insights into:

  • The US Food and Drug Administration (FDA) expectations for abbreviated new drug application (ANDA)/biosimilar submissions
  • Techniques utilized for showing product sameness
  • Strengths and weaknesses of different analytical techniques
  • Analytical challenges unique to peptides

Xtalks Partner


A leading contract service organization for over 40 years, SGS provides best-in-class services to support drug development from molecule to market, helping clients deliver high-quality, safe, and effective medicines to patients. With more than 20 GMP facilities worldwide, our global network of scientific experts accelerates drug development using innovative techniques and a consultative approach to development and formulation; as well as comprehensive quality control testing for raw materials, APIs, and finished products; and manufacturing to support phase 1 – 3 clinical trials.

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