Latest:
IP Attorneys Propose a New Biosimilar Pathway in Case of ACA Repeal
© 2023 MJH Life Sciences™ and Center for Biosimilars®. All rights reserved.
Authors
Ted Mathias, JD
Ted Mathias focuses on trying patent cases. In the last 2 years, he tried 2 cases to judgment and served as lead counsel in a case involving 33 patents that settled favorably on the eve of trial. Mathias has litigated patent cases and handled successful appeals to the Federal Circuit in the areas of medical devices, pharmaceuticals, mechanical devices, e-commerce and software.
Latest:
Opinion: Purple Book Patent Listings Are Only a First Step
Intellectual property attorneys from Axinn discuss the limitations of the Purple Book patent disclosure requirements and the burden these impose on biosimilar developers.
Lindsey Mulrooney
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Julie Reed On How the Biosimilars Forum is Helping FDA Catch Up on Biosimilar Inspections
Julie M. Reed, the executive director of the Biosimilars Forum, dives into the efforts that the Forum is taking to ensure that FDA can catch up on their inspections backlog and get biosimilar approvals back on track.
Joseph Park, PhD
Joseph Park, PhD, is the senior manager of regulatory strategy and policy at Samsung Bioepis. Park obtained his PhD from the Korea Advanced Institute of Science and Technology.
Latest:
Contributor: Interchangeability Is a Dispensing Issue, Not a Prescribing One
As more biosimilars are granted interchangeability status, 2 representatives from Samsung Bioepis stop misinformation in its tracks by clarifying that the designation will primarily impact pharmacy dispensing instead of prescription habits.
Peter Pitts
Peter Pitts is president and co-founder of the Center for Medicine in the Public Interest. He also serves as a visiting professor at the University of Paris School of Medicine. Pitts is a former member of the United States Senior Executive Service and Associate Commissioner of the US Food & Drug Administration where he served as senior communications and policy adviser to the Commissioner. He supervised FDA's Office of Public Affairs, Office of the Ombudsman, Office of Special Health Issues, Office of Executive Secretariat, and Advisory Committee Oversight and Management. He served on the agency’s obesity working group and counterfeit drug taskforce. He is a member of the Council for International Organizations of Medical Sciences (CIOMS) Expert Working Group to help advance patient involvement in the development and safe use of medicines.
Latest:
Contributor: What Is the Value of the Interchangeability Designation for a Biosimilar?
If every adalimumab biosimilar had an interchangeability designation, the United States could save additional $765 million annually, according to calculations from 3 biosimilar experts.
St John Skilton, PhD
As vice president of product strategy and marketing, St John Skilton manages the new product development at Protein Metrics Inc. With deep domain experience in MS and related analytical tools the biopharmaceutical industry, Skilton has been at the forefront of development for many years.
Latest:
Contributor: The Biosimilars Wave Is Crashing on the Shores of Biopharma Development
St John Skilton, PhD, vice president of product strategy and marketing at Protein Metrics, takes a deep dive into how the development of biosimilars is evolving and how tools, such as mass spectrometry, can help companies keep up with advancing technology.
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