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Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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According to Raoult’s law, the partial vapor pressure of a solvent in a solution is equal or identical to the vapor pressure of the pure solvent multiplied by its mole fraction in the solution. However, Raoult's Law is only valid for ideal solutions. For a solution to be ideal, the solvent-solute interaction must be just as strong as a solvent-solvent or solute-solute interaction. This suggests that both the solute and the solvent would use the same amount of energy to escape to the...
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Many common substances around us exist as a solution, such as ocean water, air, and gasoline. All solutions are mixtures of substances that are composed of varying amounts of two or more types of atoms or molecules. A mixture with a non-uniform composition is a heterogeneous mixture, whereas a mixture with a uniform composition is a homogeneous mixture. The components that make the homogeneous mixture are evenly spread out and thoroughly mixed. 
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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Similar or the Same? Why Biosimilars are not the Solution.

Lisa Diependaele1, Julian Cockbain1, Sigrid Sterckx1

  • 1Lisa Diependaele, LL.M., is an Assistant Academic Staff member at the Department of Philosophy and Moral Sciences at Ghent University. She obtained a M.A. in Moral Sciences (Ethics) at Ghent University (Belgium) in 2011, and a LL.M. in International and European Law at the Vrije Universiteit Brussel (VUB, Belgium) in 2012. Julian Cockbain, D.Phil., is a Consultant European Patent Attorney based in Gent, Belgium. After taking a degree and a doctorate in chemistry at Oxford University, he joined the patent and trademark attorney firm Dehns in London in 1979, qualifying as a UK patent attorney in 1983 and as a European Patent Attorney in 1984. He was appointed partner at Dehns in 1985, a position he held until 2012. He has published widely on patent-related matters. Sigrid Sterckx, Ph.D., is Professor of Ethics and Political and Social Philosophy at the Department of Philosophy and Moral Sciences of Ghent University. She lectures courses in theoretical and applied ethics as well as social and political philosophy. Her current research projects focus on: patenting in biomedicine and genomics; human tissue research and biobanking; organ transplantation; end-of-life decisions; and global justice. She has published widely on these issues. Diependaele, Cockbain, and Sterckx are all members of the Bioethics Institute Gent.

The Journal of Law, Medicine & Ethics : a Journal of the American Society of Law, Medicine & Ethics
|October 19, 2018
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Summary

Developing biosimilars, or generic biologics, is complex and costly, failing to significantly lower prices or improve access. A mandatory cell line deposit during regulatory approval is proposed to address these challenges.

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Area of Science:

  • Biotechnology
  • Pharmaceutical Sciences
  • Regulatory Science

Background:

  • Biologics, manufactured from living cells, face challenges with generic versions called biosimilars.
  • Biosimilar development aims to reduce costs and increase access to complex biologic drugs.
  • Current biosimilar pathways present significant hurdles in cost, time, and safety validation.

Purpose of the Study:

  • To analyze the challenges in biosimilar development and market introduction.
  • To examine how biologic production complexities affect patent and regulatory exclusivity.
  • To propose a novel regulatory mechanism to improve biosimilar accessibility and reduce costs.

Main Methods:

  • Analysis of the biologics production process and its impact on biosimilarity.
  • Review of traditional patent protection and regulatory exclusivity frameworks.
  • Proposal of a mandatory cell line deposit system for regulatory approval.

Main Results:

  • Biosimilar development is resource-intensive, leading to limited price reductions and persistent safety/interchangeability concerns.
  • The complexity of biologic manufacturing creates unique challenges for generic competition.
  • Current regulatory and patent systems may not adequately incentivize true biosimilar competition.

Conclusions:

  • The development of biosimilars has not met expectations for cost reduction and increased access.
  • Mandatory deposit of the original biologic's cell line at regulatory approval is proposed as an effective remedy.
  • This mechanism could enhance transparency and potentially facilitate the development of more affordable biosimilars.