Federal agencies - such as the FDA and the Centers for Medicare and Medicaid Services - issue draft guidance documents for public comment.  PBSA and our member companies reply to these requests to ensure that the patient voice is represented in these agencies' decision making processes. 


In July 2017, PBSA and its member organizations submitted written testimony to the FDA's Oncology Advisory Committee on the approval of a two new biosimilars.

In May 2017, PBSA and its member organizations submitted written testimony to the FDA's Oncology Advisory Committee on the approval of a new biosimilars.

In May 2017, PBSA and its member organizations submitted comments to the FDA on their proposed interchangeability guidance for biosimilar products.

In October 2016, PBSA and its member organizations submitted comments to the FDA in response to the BsUFA Commitment Letter that announced the delay of critical biosimilar guidances. 

In August 2016, PBSA and its member organizations submitted supplemental comments to the FDA in response to its draft guidance on the labeling of biosimilars products.

In July 2016, PBSA and its member organizations submitted written testimony to the FDA's Arthritis Advisory Committee on the approval of the two biosimilars, for etanercept and adalimumab respectively.  

In June 2016, PBSA and its member organizations submitted comments to the FDA in response to its draft guidance on the labeling of biosimilars products.

In April 2016, PBSA and its member organizations released a statement in response to the FDA's approval of the second U.S. biosimilar, Infliximab.

In March 2016, PBSA and its member organizations released a statement in response to the FDA's draft guidance for industry: Labeling for Biosimilar Products.

In February 2016, PBSA and its member organizations submitted written testimony to the FDA's Arthritis Advisory Committee on the approval of the biosimilar, Infliximab.  

In September and October 2015, PBSA and several of our member organizations provided comments on the FDA's Draft Guidance titled, "Nonproprietary Naming of Biological Products; Draft Guidance for Industry:"