On September 24, 2015, the United Kingdom’s National Health Service (NHS) released a biosimilars guidance document, available here. In it, the NHS bans automatic substitution of biosimilars, meaning that pharmacists may not switch between biosimilars and reference biologics, or between one biosimilar and another, without the consent of the prescribing…
Earlier this year, the Center for Medicare and Medicaid Services (CMS) proposed new rules that would regulate payment for biosimilars, creating a single payment category for all biosimilars of the same reference biologic. Under the proposed scheme, Medicare and Medicaid payments for those biosimilars would be based on the average…
It was announced this morning that the U.S. has reached an accord on the Trans-Pacific Partnership Agreement (TPP). As we reported in previous posts on this topic, one major point of dispute between parties to the negotiations was the length of the data exclusivity period that member-states would need to…
As we previously reported, negotiations on the Trans-Pacific Partnership Agreement, for which President Obama has been given fast-track authority to negotiate, are well underway, and leaders have been meeting this week in Maui to iron out what many believe will be the final deal. One of the most contentious issues…
Goodwin Procter announced today the publication of Pharmaceuticals at the Patent Trial and Appeal Board, a guide that addresses proactive measures for pharmaceutical companies involved in litigation before the PTAB. The guide explores key statistics and case studies that reveal how the PTAB is handling pharmaceutical matters and lays out…
As we covered in a previous post, confidential negotiations regarding the Trans-Pacific Partnership Agreement (TPP) are ramping up: the Senate passed fast-track legislation in June, which limits Congress to a yes-or-no vote on the eventual trade agreement with no amendments, and a meeting of the TPP Trade Ministers is scheduled…
In a move that may impact the continuing debate over how to name and label biosimilar biologics, the World Health Organization (“WHO”) has released a new draft of its proposal for assignment of Biological Qualifiers (“BQ”). The BQ proposal aims to standardize naming of biologics by giving each approved and marketed…
On June 23, 2015, the U.S. Senate authorized President Obama to negotiate on a “fast-track” basis the Trans-Pacific Partnership agreement (TPP). TPP is a proposed trade agreement between several pacific countries concerning a variety of matters, including intellectual property and pharmaceutical products. Negotiations over TPP, which have been taking place…
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…
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…