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Development of Biosimilars is Both Challenging and Exciting
Welcome to Healio Rheumatology. I am delighted and privileged to be the Chief Medical Editor of the publication. I am thrilled to have the opportunity to work with such an extraordinary Peer Perspective Board as well as the professionals from SLACK Incorporated, publisher of Healio Rheumatology, who are committed to make it the leading publication of its kind.
Each issue will bring readers the latest in cutting-edge research and relevant news from the world of rheumatology presented in a way that is understandable and relevant to clinical practice. I look forward to continuing my commitment to rheumatology education by covering and synthesizing not only the peer-reviewed literature, but also adding perspective on the most important meetings in the field worldwide.
In the Cover Story of this premier issue, Healio Rheumatology explores the fast and evolving advances in the development of biosimilars — a long-sought goal for both physicians and patients. The field surrounding the discovery of biosimilar agents, which are defined as a “biologic medical product,” that is a copy of an original product manufactured by a different company, is both challenging and exciting.
The challenges are two-fold. The first challenge is how to create a “perfect copy” of a large macromolecule, such as a monoclonal antibody with multiple chains, complex primary, secondary, tertiary and quaternary structure, as well as the extensive post-translational modifications needed for the biosimilar to behave equivalently to the original product in every way both pharmacologically and clinically. It has been analogized that copying aspirin, a molecule with no amino acids and a molecular weight of 180, is like making a copy of a bicycle. Copying an antibody of molecular weight in excess of 148,000 with allots spatial and posttranslational complexity is like trying to make a copy of the space shuttle. Bioengineering is indeed complex.
Leonard H. Calabrese
The second challenge in the development of biosimilars is regulatory. Global health agencies are creating guidance positions to address the development of such agents and many questions remain. Will approval for one indication give immediate approval for all indications? This is a burning question. How big should the trials be? What are the endpoints and what equivalence windows need to be targeted? As if these issues are not enough to regulate, there are questions about interchangeability. Do rheumatologists want patients to be switched from a brand product to biosimilar and then possibly switched again to the next new biosimilar at the will of a pharmacy or managed care organization without our agreement? Other questions remain about the ramifications for long-term efficacy and toxicity, and how rheumatologists can prove there are no significant risks through clinical trials.
The reason we have come this far through all of these challenges in the development of biosimilars is that the benefits to patients and the economy are potentially huge. It has been estimated that biosimilars have the potential to save the U.S. economy as well as bring in billions of dollars per year. In the United States, the FDA approved the first non-brand complex biosimilar this year in the form of filgrastim-sndz. The cost savings are currently a meager 15% over branded granulocyte-colony stimulating factor. In Europe, particularly Norway, the first biosimilar infliximab (Remsima; Celltrion), was introduced at a 69% initial discount to the branded Remicade. In this election season, I ask each of you to ponder the reasons for such differential pricing.
In closing, I encourage you to read this premier issue of Healio Rheumatology and give us your feedback. Look for monthly publication to begin in March 2016. I look forward to hearing from readers on what important topics they would like covered in future issues. You can reach me by email at calabrl@ccf.org or on Twitter @LCalabreseDO. Thanks for reading.
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- Leonard H. Calabrese, DO, is the Chief Medical Editor of Healio Rheumatology, and Professor of Medicine, College of Medicine of Case Western Reserve University, and RJ Fasenmyer Chair of Clinical Immunology at the Cleveland Clinic.
Disclosure: Calabrese reports he is a consultant for Genentech, Pfizer, Bristol-Myers Squibb, GlaxoSmithKline, Sanofi, Jansen and Abbvie; and is on the speakers bureau for Genentech, Abbvie and Bristol-Myers Squibb and Crescendo Bioscience.