A collection of associations for higher education wrote to FDA Commissioner Margaret Hamburg urging a requirement for biosimilar applicants to certify that they have complied with the information exchange and patent dispute resolution provisions of the BPCIA. The concern raised is that: “biosmilar sponsors can effectively circumvent every patent litigation provision of the statute simply… Continue Reading
Category Archives: News & Events
Subscribe to News & Events RSS FeedEMA takes steps toward facilitating global clinical trials for biosimilars
Applicants for marketing authorisation for biosimilars in the European Union (“EU”), under certain conditions, will be able in the near future to use batches of reference biological medicinal products sourced from outside the European Economic Area (“EEA”) in pre-clinical and clinical studies that are part of the comparability exercise preceding authorisation of biosimilars. On 28… Continue Reading
FDA has announced rates for biosimilar user fees for FY 2013
The biosimilar biological product development (BPD) fee has been set at $195,880 (10% of the full application fee). This is the amount due when a sponsor submits an investigational new drug (IND) application for a biosimilar (or within 5 days of FDA granting a BDP meeting request – whichever occurs first). When a sponsor is… Continue Reading
Biosimilars Marching Forward as Planned
With the 5-4 decision from the U. S. Supreme Court upholding almost the entire Patient Protection and Affordable Care Act, for those who were hoping for a fresh opportunity to re-debate the biosimilars statute, and perhaps plug some holes or make some basic changes to the law, those hopes have been dashed for now. While… Continue Reading
Breaking decisions from the Supreme Court: Term in review
On Tuesday afternoon, three of Hogan Lovells’ Appellate practice partners will provide an analysis of some of the key decisions that will impact businesses as the Supreme Court concludes its current term. Neal Katyal, former Acting Solicitor General of the United States and Appellate practice Co-Director, Cate Stetson, Co-Director of our Appellate practice; and Chris… Continue Reading
Making U.S. Biosimilars a Reality – Everyone Seeks Clarity and Direction from FDA
The usual suspects from regulated industry, patient and physician groups turned out for the U.S. Food and Drug Administration’s public meeting on the biosimilars guidances. Now that the draft guidances have been out for several months and the FDA has a stack of comments to consider, the dialogue has moved from the theoretical to the… Continue Reading
SCOTUS review of the Patient Protection and Affordable Care Act and “the biosimilar thing”
While a Supreme Court ruling on the constitutionality of the healthcare reform law is not expected until June, sponsors and regulators continue to lay the groundwork for biosimilars in the U.S. An unintended consequence of embedding the Biologics Price Competition and Innovation Act within PPACA without a severability clause leaves the biosimilars law vulnerable to… Continue Reading
Awaiting FDA Guidance on Interchangeability for Biosimilars
The three draft Guidances recently released by the U.S. Food and Drug Administration on implementation of the Biologics Price Competition and Innovation Act of 2009 focus on how to demonstrate biosimilarity but don’t say much about demonstrating interchangeability. FDA has asked for stakeholder input on biosimilar interchangeability at the agency’s upcoming one-day public hearing on… Continue Reading
Biosimilars: Who’s Who at FDA?
According to several recent presentations by U.S. Food and Drug Administration (FDA) officials, the agency has established three committees charged with discussing and coordinating issues related to biosimilars to ensure consistency in the regulatory approach and guidance to sponsors. While FDA set up this infrastructure some time ago, with the issuance of the Draft Guidances… Continue Reading
Public Comment on FDA Draft Biosimilars Guidances
Thoughts on the U.S. Food and Drug Administration’s recently issued biosimilar guidance documents? The time to act is now. As described in our earlier post , FDA must provide the public an opportunity to comment on the three recently issued biosimilars draft guidances. 42 USC 262(k)(8)(B)(i). As described in the announcement notices in the Federal… Continue Reading
FDA’s Long-Awaited Biosimilars Guidances—The Prologue to Biosimilars in the U.S. has been published
The U.S. Food and Drug Administration released three draft Guidances on implementation of the Biologics Price Competition and Innovation Act of 2009. The Q&A, Scientific Considerations, and Quality Guidances cover the overall framework for biosimilar application requirements as envisioned by FDA. Notably, FDA has deferred guidance on how to establish interchangeability. FDA emphasizes a “step-wise”… Continue Reading