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Tony Hagen is senior managing editor for The Center for Biosimilars

During a talk at the Medicines for Europe Biosimilar Medicines Conference, US and EU regulators discuss the potential for tailored approach to bring biosimilars to market sooner with less expense and wasted effort. 

US, EU Regulators Discuss Tailoring Biosimilar Approvals

Stacie Ropka, JD, PhD, is a partner at Axinn. Her practice focuses on intellectual property litigation, due diligence, and client counseling, with an emphasis on the life sciences. Ropka’s experience includes extensive counseling for product development efforts relating to biologics and reconstructive biomaterials, including products that utilize adult stem cells. Prior to attending law school, she held a faculty position at SUNY Upstate Medical University, and she also spent many years as a research scientist in the fields of neurology, virology, and immunology.

Drew Hillier, JD, is an associate at Axinn. He litigates patent cases and high-stakes commercial disputes. His experience includes advising follow-on biologic manufacturers on product development and litigation strategy. As a former federal law clerk, Hillier has litigated patent-related cases in some of the highest-profile districts in the country, including the Southern District of New York and the Eastern District of Texas.

Gabriella Mahan, JD, is an associate at Axinn’s Washington, DC office. At the time of this writing, her admission to the Washington, DC Bar is pending.

Intellectual property attorneys from Axinn discuss the limitations of the Purple Book patent disclosure requirements and the burden these impose on biosimilar developers.

Opinion: Purple Book Patent Listings Are Only a First Step

Maria Manley, LLM, a life sciences expert and London-based partner with Sidley Austin, provides a deep-dive look at the complexities of Brexit and how it is likely to challenge the biologics industry.

Maria Manley Discusses the Consequences of Brexit for the Pharmaceutical Industry

The anatomy of an interchangeability switching study. 

The Difference Between an Interchangeable Biosimilar and One That Isn't

Biosimilar companies partnered with other companies and saw earnings increases, while reference product corporations faced sales erosion from biosimilar competition.

Biosimilar Business Roundup for April 2021

Representative Carolyn B. Maloney, D-New York, questions the use of pharmaceutical profits to defend against biosimilar competition. 

AbbVie CEO Is on Deck as Antitrust Hearings Heat Up

Biocon tests the waters with itolizumab in pandemic-ravaged India, and Celltrion announces early success with an agent for the South African variant. 

Reports From Biocon, Celltrion on Finances, COVID-19 Treatments

How much muscle did Congress invest in a pair of bills recently signed by President Biden? The answer may lie in your willingness to believe. 

Toothful or Toothless? Biden's Biosimilar Bills Under the Microscope

The European Union is a diverse market with pockets of biosimilar resistance but also cost-saving triumphs, panelists said at the Biosimilar Medicines Virtual Summit 2021.

Medicines for Europe Panel Tackles Biosimilar Uptake

Russia's land area is vast relative to its population, but Prestige Biopharma eyes an ample market for its bevacizumab biosimilar candidate (HD204).

Regulatory