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Tony Hagen is senior managing editor for The Center for Biosimilars

The FDA's Office of Therapeutic Biologics and Biosimilars balances a large number of biosimilar development projects with limited resources and is making progress, says Eva Temkin, acting director of policy.

FDA's Eva Temkin Discusses Biosimilar Approvals at ACI

Courts have allowed biosimilar developers "safe harbor" against infringement suits, but there are limits, attorneys from Goodwin Proctor explain.

Goodwin Attorneys Discuss Hospira-Amgen Infringement Case

Representative Glenn Grothman, R-Wisconsin, says interchangeability for insulins makes sense based on the savings potential and safety record of these agents.

Rep Grothman Introduces Bill for Automatic Insulin Biosimilar Interchangeablity 

April E. Weisbruch is a partner at McDermott, Will, & Emery LLP. She focuses her practice on intellectual property (IP)  matters, particularly in managing large-scale IP litigation and counseling. She works with clients in wide-ranging technology sectors, including pharmaceuticals, software applications, medical devices, organic chemistry and ballistics. April represents clients in all phases of patent litigation, from the filing of a complaint through appeal, as well as in the highly specialized post-grant proceedings before the United States Patent Trial and Appeal Board (PTAB). She has extensive deposition, hearing and trial experience in US district courts throughout the country, as well as in the US Court of Federal Claims, the US Court of Appeals for the Federal Circuit, and the PTAB. Her litigation experience includes traditional "competitor" litigation, litigation against nonpracticing entities, ANDA litigation under the Hatch-Waxman Act and §1498 litigation against the United States of America.

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.

What We Learned About Biologics on Summer Vacation

The Association for Accessible Medicines, which represents generic and biosimilar manufacturers, chose a leader with a research, public relations, and strategic planning background.

Dan Leonard Takes Helm of Association for Accessible Medicines

Opinion leaders discuss the significance of regulatory changes affecting biosimilar and insulin products.
 

Expert Opinion Roundup: New Insulin and Biosimilar Regulation

Two Biogen officials make the case for getting anti–tumor necrosis factor (TNF) biosimilars into wider play.

Biogen: Anti-TNF Biosimilars Are Underutilized

A Pacific Research Institute economist says that by his scorecard, biosimilars are not supercharging the market the way they ought to be doing .

Winegarden: Biosimilars Market Lacks Oomph

Opening the door to biosimilar competition starts with breaking down the patent barrier, says Christine Simmon, JD.

Christine Simmon and the Fight for Patent Reform

If you can’t beat biosimilars, join them, is the mantra; but at Amgen there’s still gold in originator products, according to its latest earnings report.

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