Legal

Interview: Understanding the Attraction for PD-1 Inhibitor Biosimilars

October 13, 2020

Tony Hagen

Article

Years ahead of patent expirations for programmed death-1 (PD-1) inhibitors, biosimilar companies have begun focusing on these targeted drugs.

PIRG Files Amicus Brief in Support of Humira Plaintiffs

October 13, 2020

Tony Hagen

Article

The US Public Interest Research Group (PIRG) contends AbbVie's patent thicket for Humira (adalimumab) will encourage anticompetitive practices by other manufacturers.

Meier Explains FTC's Power to Pursue Antitrust Activity

September 30, 2020

Tony Hagen

Article

The Federal Trade Commission's powers to bring antitrust actions are circumscribed by public versus private and what is vs isn't "reasonable," Markus H. Meier explained.

California's Governor Signs Bill for State to Produce Its Own Biosimilars, Insulins

September 29, 2020

Skylar Jeremias

Article

California has become the first state to implement a policy to produce and distribute its own drug products to help lower costs.

FTC's Markus H. Meier Talks About Restraint of Trade in the Biosimilar Marketplace

September 28, 2020

Tony Hagen

Article

Some acts by companies in the biologics marketplace may go too far in preventing free market activity, according to Markus H. Meier, acting director for the Federal Trade Commission (FTC) Bureau of Competition.

FDA's Eva Temkin Discusses Biosimilar Approvals at ACI

September 23, 2020

Tony Hagen

Article

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.

Goodwin Attorneys Discuss Hospira-Amgen Infringement Case

September 15, 2020

Tony Hagen

Article

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

Rep Grothman Introduces Bill for Automatic Insulin Biosimilar Interchangeablity

September 15, 2020

Skylar Jeremias

Article

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

What We Learned About Biologics on Summer Vacation

September 12, 2020

April E. Weisbruch, JD

Article

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.

Dan Leonard Takes Helm of Association for Accessible Medicines

August 27, 2020

Tony Hagen

Article

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

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