Regulatory Strategies for the Analytical Development of New Biological Entities and Biosimilars

Life Sciences, Pharmaceutical Regulation, Drug Discovery & Development, Biosimilars,
  • Wednesday, April 17, 2019

The webinar will focus on the relationship between analytics of biotherapeutic products and the interpretation of data to build and support a solid regulatory Chemistry, Manufacturing and Control (CMC) strategy. The importance of data interpretation is illustrated in the development of biosimilars and new biological entities, as well as in regulatory specifications regarding biotherapeutic products. 

The successful development of a biosimilar requires an upfront investment into its manufacture to match the molecular attributes of the originator and establish in vitro biosimilarity. The broad definition of the similarity concept in regulatory guidelines does not directly prescribe a path for this task. Despite this uncertainty, several manufacturers have been successful and numerous follow-on biologics are approved in the US and EU as of today. An analysis of recently approved US biosimilar products with respect to the chosen analytical similarity or comparability approach will be presented in this webinar to highlight the various quality parameters investigated for an effective follow-on strategy. The biosimilarity analysis is enabled with a precise selection of the reference material to allow for an exact definition of the design space for the various quality attributes. This overview is complemented with analytical examples from functional assays and glycan structure analysis to illustrate the significance of data interpretation in support of the regulatory dossier.

In the context of new biological entities, presented case studies will illuminate examples with respect to oxidation and acidic variant formation. The examples focus once more on the importance of understanding the data and analyzing similarity by interpreting differences within the molecular context utilizing prior knowledge.

Third and last, common specifications for biotherapeutic products will be presented. This discussion will include common push back and observations from North American and European regulators. Further case studies will be presented to illustrate strategies used to successfully avoid common regulatory traps.

In summary, a strong analytical portfolio paired with prior knowledge is essential for the development of a comprehensive analytical strategy for biotherapeutics. When it comes to the interpretation of data, a careful assessment of the differences utilizing prior knowledge is essential.


Thomas Linnemann, PhD, Head of Regulatory CMC Customer Solutions, Solvias

Dr. Thomas Linnemann completed his PhD thesis in biochemistry at the Max Planck Institute of Molecular Physiology in Germany. He was a post-doc at the Howard Hughes Medical Institute at the University of California, San Francisco before moving to the biotech industry. He developed strategies to identify novel protein therapeutics at FivePrime Therapeutics, CA and contributed to biologics development at Novartis in the technical analytical function and in Regulatory CMC before joining Solvias.

Message Presenter

Who Should Attend?

This webinar will benefit those working in the pharmaceutical, biotech, generics and biosimilars industries.

Relevant job titles include:

  • Project Leader
  • Director of R&D
  • Business Development Manager
  • Project Manager
  • Process Development Chemist
  • Technology Development Manager
  • Principal Fellow
  • Discovery Chemist
  • Laboratory Head
  • Lead Buyer
  • Key Account Manager
  • Director of Sales & Marketing
  • Leading Scientist
  • Associate Scientist
  • Principal Scientist
  • Senior Scientist
  • Purchasing Manage
  • Team Leader
  • Consultant
  • Scientific Officer



What You Will Learn

In this webinar, attendees will gain insight on:

  • Effective CMC strategy development
  • How analytical similarity is achieved in biosimilars based on recently approved products in the US
  • Interpreting data from functional assays, glycan structure analysis and other tests in the development of biosimilars and new biological entities
  • An overview of US and EU regulations and best practices to avoid common regulatory traps

Xtalks Partner


Solvias is a world leader in contract research, development and manufacturing. The industries we serve include pharmaceuticals, biotech, medical devices and cosmetics. Solvias is mainly management- and employee-owned and headquartered near Basel, Switzerland. Over 450 highly-qualified employees work together as a team to understand our customers’ needs. We take pride in delivering innovative solutions that meet the highest quality standards. With our excellent infrastructure and unrivalled expertise, we develop, analyze and test a wide range of biological and chemical substances and products. Drawing on our well-established scientific experience and proven track record, we provide integrated services, products and technologies that enhance the value chain for customers worldwide.

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