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Category Archives: News & Events

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Posted in News & Events

FDA Anticipates New Draft Biosimilar Guidances

Including biosimilars in the release of expected 2014 CDER draft guidance documents has sparked the public interest as industry, physicians, patients and others await additional cues on FDA’s implementation of the BPCIA.  The Center for Drug Evaluation and Research’s 2014 agenda for new and revised draft guidances includes the following for Biosimilars: Biosimilars: Additional Questions

Posted in News & Events

Europe approves its first mAb biosimilar & FDA is handling 17 biosimilar INDs

Not surprising after the European Medicines Agency (EMA) positive opinion for two biosimilars to Remicade (infliximab) in June, the first of these was authorized in September.  Authorization of Remsima represents the first monoclonal antibody biosimilar, and the thirteenth biosimilar, authorized in the European Union. In the United States, the Food and Drug Administration is into

Posted in News & Events

FDA Activities During Government Shutdown

The U.S. Food and Drug Administration staff will continue User Fee supported activities and vital consumer protection activities during the government shutdown.  FDA staff, including review divisions and chief counsel’s office, will continue work on regulatory activities covered by user fees under the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA),

Posted in Biosimilars Patent Exchange, News & Events

Universities urge FDA to require certification of information exchange for biosimilar applications

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

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EMA 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

Posted in News & Events

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

Posted in News & Events

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

Posted in News & Events

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

Posted in News & Events

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

Posted in News & Events

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

Posted in News & Events

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

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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

Posted in News & Events

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”