A bill introduced in the House of Representatives yesterday proposes “[t]o amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 7 years.” Titled the “Price Relief, Innovation, and Competition for Essential Drugs Act,” or the “PRICED Act,” the proposed bill…
The Big Molecule Watch team looks forward to seeing you during the next couple of days at American Conference Institute’s 7th Annual Biosimilars Summit. Our colleague, Goodwin partner Sarah Frederick, will address how to distinguish a biosimilar product from the reference product while minimizing the risk of legal claims that may…
Last month, the governor of Arizona signed a bill into law allowing pharmacists to automatically substitute a biosimilar for a reference branded biologic. Arizona continues the recent trend of states enacting biosimilar automatic substitution laws, including, for example, New Jersey and Oregon. Under the new Arizona law, from December 31, 2016 onward,…
On June 14th, Rob Cerwinksi will speak at American Conference Institute’s 7th Annual Biosimilars Summit. Rob will address how to distinguish a biosimilar product from the reference product while minimizing the risk of legal claims that may arise from the promotion. Goodwin and the Big Molecule Watch team have a…
Today, the Wall Street Journal published an article by Jonathan D. Rockoff that takes an in-depth look at the actual and expected pricing of biosimilars in the U.S. For those with WSJ subscriptions, it is well worth a read: http://www.wsj.com/articles/knockoffs-of-biotech-drugs-bring-paltry-savings-1462458209.
The Biosimilar User Fee Act (BsUFA) requires FDA to contract with an independent accounting or consulting firm to study the workload volume and full costs associated with the process for the review of biosimilar biological product applications. On February 24, 2016, the FDA released the Final Results Report of its…
The House Energy & Commerce Committee’s Subcommittee on Health met this morning to discuss implementation of the Biologics Price Competition and Innovation Act. Sean Cavanaugh, Deputy Administrator and Director of the Center for Medicare, and Janet Woodcock, Director of the Center for Drug Evaluation and Research, testified. The subcommittee’s questioning…
Today, the FDA released the latest version of its Guidance Agenda for the upcoming year. Among the new and revised draft guidances that CDER plans to release are the following three guidances concerning biosimilarity: Considerations in Demonstrating Interchangeability With a Reference Product Labeling for Biosimilar Products Statistical Approaches to Evaluation…
Goodwin Procter and the Big Molecule Watch team are looking forward to participating in the 34th Annual J.P. Morgan Healthcare Conference, which brings together leaders from across the industry. If you will be in San Francisco for the conference, we hope you will join us next Wednesday, January 13, 2016,…
FDA recently proposed a new biosimilar naming convention, whereby the nonproprietary name for a biological product would require a new, random four-letter suffix. The new naming convention is in the spirit of emphasizing that biosimilars, unlike generic drugs, are not replicas of their biologic counterpart. In its response to the…