Latest:
IP Attorneys Propose a New Biosimilar Pathway in Case of ACA Repeal
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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
Latest:
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.
Gillian Woollett, MA, DPhil
Gillian Woollett, MA, DPhil, is the the vice president and head of regulatory strategy and policy at Samsung Bioepis. Prior to her work at Samsung Bioepis, she served as Avalere Health's senior vice president for over 10 years.
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.
Paul Cornes, BM, BCH, MA, MRCP, FRCR
Paul Cornes, BM, BCH, MA, MRCP, FRCR, is a consultant oncologist and biosimilars expert who was part of the team that developed and presented evidence to the FDA for the first successfullly approved US biosimilar.
Latest:
Column: India Struggles to Meet International Biologics Standards
An internationally recognized authority on biosimilar development discusses varieties of copy biologics in India and the need to distinguish these from true biosimilars.
Meaghan Smith
Meaghan Smith is the executive director of the Biosimilars Forum. She previously served as a senior adviser and communications director at HHS during the Obama administration.
Latest:
Opinion: Biosimilars Offer Savings and Access for US Patients
In this column, officials from the Biosimilars Forum and Xcenda discuss how biosimilar competition has lowered prices of originator biologics and improved patient access.
Monica Mallampalli, PhD, MSc
Monica Mallampalli, PhD, MSc, is senior advisor for Scientific and Strategy Initiatives at HealthyWomen.
Latest:
Biosimilars and Women's Health: Realizing the Potential
The potential and promise of biosimilars are there—it is up to all of us to bring it to reality so we can expand access to safe, effective, affordable drugs for women.