AbbVie filed a Citizen Petition on June 2, 2015 demanding that FDA impose three labeling requirements on biosimilar applicants. “Biosimilars are not generic drugs and should not be labeled like generic drugs” AbbVie stated, and demanded that the FDA require biosimilars to contain various statements in their labels to distinguish…
In April 2015, the FDA released three updated non-binding guidances regarding the process for biosimilar approval under section 351(k) of the Public Health Service Act (“PHS Act”) as amended by the Biologics Price Competition and Innovation Act of 2009. These publications, Biosimilars: Questions and Answers Regarding Implementation of the Biologics…
We joined a packed courtroom at the Federal Circuit Court of Appeals yesterday to observe oral arguments in the Amgen v. Sandoz appeal. Judge Newman, Judge Lourie, and Judge Chen were on panel for the hearing. As we’ve covered in other posts (here and here), this case has drawn a…
Amgen appealed the district court order on March 25, 2015, and sought an expedited briefing schedule and an injunction to delay the launch of Sandoz’s Zarxio product while the Court considers Amgen’s appeal. The Federal Circuit granted the motion for an expedited schedule, and set oral argument for June 3,…
As discussed in our introductory post, the BPCIA lays out a series of steps to resolve patent disputes involving biosimilars. According to these steps, once a biosimilar applicant receives notice from FDA that its application has been accepted for review, the applicant provides the reference product sponsor with a copy…
Below we provide a short introduction to the world of biologics and the BPCIA. For a more comprehensive guide on biosimilars, check out Goodwin Procter’s Biosimilars: A Guide to Regulatory and Intellectual Property Issues. What are biologics? Biologics are medical products such as vaccines, therapeutic proteins, and gene therapies that…