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
Biosimilars Law Blog
The Biosimilars Law Blog, published by Hogan Lovells, focuses on legal developments and regulatory issues related to biosimilar products. It covers topics such as the Biologics Price Competition and Innovation Act (BPCIA), patent litigation and exclusivity for biosimilars, FDA guidance on biosimilar approval, interchangeability, and labeling, as well as international regulatory perspectives. The blog also discusses court rulings impacting biosimilar market entry and legal strategies for biosimilar applicants and reference product sponsors. It addresses the evolving landscape of biosimilar policy, clinical and legal considerations for biosimilar interchangeability, and the implications of biosimilar use in healthcare systems.
Latest from Biosimilars Law Blog - Page 3
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…
President signs The Food and Drug Administration Safety and Innovation Act: Summary of certain key provisions
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…
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…
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…
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…
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…
Biosimilars: Who’s Who at FDA?
By David Fox
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…
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…