Latest:
Opinion: The Legal and Regulatory Year in Review
Intellectual property law attorneys from Axinn discuss regulatory and legal events in 2020 that will affect biosimilar markets in 2021.
© 2021 MJH Life Sciences™ and Center for Biosimilars®. All rights reserved.
Authors
Drew Hillier JD
Drew Hillier is an associate with
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Intellectual property attorneys discuss the Supreme Court oral arguments over the Affordable Care Act (ACA) and implications for the Biologics Price Competition and Innovation Act (BPCIA).
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.
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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.
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.
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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.
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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.
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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.
Robert Spina, MBA
Robert Spina, MBA, is vice president of Marketing, Market Access, and Patient Services at Sandoz.
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Opinion: Support Health Equity and Access to Health Care With More Affordable Treatment Options
Changes in federal and state policy can help liberate the savings potential in biosimilars and broaden investment in our health care system.
Christopher M. Bruno, JD
Christopher M. Bruno is an associate in the Intellectual Property group at McDermott, Will, & Emery LLP, and a former law clerk of the United States Court of Appeals for the Federal Circuit and of the United States District Court for the Central District of California. With a focus on pharmaceutical patent litigation, he has litigated Hatch-Waxman Act cases from pre-complaint investigation through appeal in district courts, the Federal Circuit, the Supreme Court, and the International Trade Commission. Chris was one of the first attorneys with experience litigating the meaning of provisions of the Biologics Price Competition and Innovation Act of 2009, and he continues to play a role in decoding the relatively nascent territory of biosimilar litigation.
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What We Learned About Biologics on Summer Vacation
Intellectual property law attorneys from the Washington, DC, offices of McDermott Will & Emery LLP, discuss 5 of the most significant trends in biologics litigation that have emerged in recent months.