ACI 11th Summit on Biosimilars & Innovator Biologics

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.

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.

Two bills in Congress meant to address the anticompetitive practice of product hopping drew fire at the American Conference Institute's annual biosimilars conference.

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.

Panelists at American Conference Institute's (ACI) 2020 virtual summit discuss California's legislative attempts to improve competition in the drug industry.

Industry insiders discuss current trends about the patent dance and other issues, as well as proposed legislation that could affect biosimilar development.

Courts will be busy with biosimilar litigation for the foreseeable future, attorneys predicted at a panel on the second day of the ACI 10th Summit on Biosimilars.

A panel at the ACI 10th Summit on Biosimilars focused on the recent FDA decision around the naming of biosimilar products and what that means for the industry, as well as related issues.

The first set of presentations on day 2 of the ACI 10th Summit on Biosimilars on Tuesday in New York City reviewed the economics of biosimilar drugs and considerations for access, pricing, and reimbursement.

Under which situations might the International Trade Commission (ITC) be the right choice for biosimilar patent disputes instead of federal district court? A panel discussed these questions at the ACI 10th Summit on Biosimilars on Monday in New York City.

With a variety of policy ideas circulating around Washington, DC, in regards to stimulating biosimilar competition and lowering drug prices, the role of the FDA is to provide technical assistance to those legislative staffers and others looking for information, a key FDA official told a packed audience at the ACI 10th Summit on Biosimilars on Monday in New York City.

In a presentation during the American Conference Institute’s Summit on Biosimilars, held June 25-27 in New York, New York, Laura Sim, JD, senior counsel at Amgen, and Vishal Gupta, JD, partner at Steptoe & Johnson LLP, discussed various naming and labeling considerations that stakeholders need to consider for biosimilars.

Although no biosimilar has earned an interchangeable designation by the FDA to date, the distinction could garner more biosimilar uptake. In a presentation during the American Conference Institute’s Summit on Biosimilars, held June 25-27 in New York, New York, various stakeholders discussed how interchangeability is the future of the space.

Isaac Ashkenazi, partner at Paul Hastings LLP; Gregory Morris, PhD, partner and leader of life sciences litigation at Honigman Miller Schwartz and Cohn LLP; and John Molenda, PhD, partner and co-chair of Healthcare & Life Sciences practice at Steptoe & Johnson LLP, discussed current “hot button” litigation issues in the biosimilar sphere during the American Conference Institute’s Summit on Biosimilars, held June 25-27.

At the American Conference Institute (ACI)’s Summit on Biosimilars Conference, held June 25-27 in New York, New York, panelists Crystal Kuntz, vice president of healthcare policy and research at Biotechnology Innovation Organization, and David Korn, vice president of intellectual property and law at Pharmaceutical Research and Manufacturers of America, provided an overview of recent policy and legislative updates in regard to biosimilars.