Safety Should be Paramont for New Biosimilars

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January 28th, 2015

The statement below was given at a Food and Drug Administration (FDA) meeting where they were deciding whether to approve the first biosimilar (a drug that is similar to the biologic drug NEUPOGEN (filgrastim), a drug used in cancer treatments.  While this similar drug will save money the FDA hasn’t yet decided on what safety regulations will be in place for this and future biosimilars and this concerns us.  How can the FDA approve a new complicated form of medicine without any safeguards in place?  I hope the FDA isn’t waiting until the last minute to release these important regulations to avoid an open and transparent review by patient groups, advocacy organizations and industry.  They have had years to consider these important regulations and have repeatedly promised there release yet here we are with the first approved biosimilar and no idea what safety measures will be in place or tracking mechanism will be available in case of adverse reactions. My testimony below voiced these concerns.

Statement given at the Open Public Hearing portion of the FDA Oncologic Drugs Advisory Committee meeting, January 7th, 2015

Good afternoon, my name is Thair Phillips, I’m the President of RetireSafe, a nationwide, non-profit, advocacy organization for older Americans.  I’m here today to represent our 400,000 supporters and to give a voice to those who will ultimately be patients receiving these new life extending and life enhancing medicines.

While the topic today is largely about one specific biosimilar application, the implications for patients extend beyond one drug.  Our concern is for the safety of the patients.

To accurately represent our supporters we reached out to them through a survey to measure what they know about biologics and biosimilars and the potential safety issues surrounding these new medicines.  We asked a series of questions and then gave them a chance to comment.  More than 1400 supporters responded to the survey and the results were very interesting.

Survey respondents expressed overwhelming support for patient safeguards.

  • 92 percent of seniors want drug companies to test the safety of biosimilars for all conditions they will be used to treat, and 86 percent want human clinical trials to take place.
  • 90 percent of seniors want each biosimilar product to have a different name than the original biologic so that patients and physicians can adequately track adverse reactions.
  • 94 percent believe patients should be notified when a biosimilar is substituted for the original drug prescribed by a doctor, and 91 percent want physicians to be notified whenever such substitution happens.

We realize that asking questions that concern safety will usually bring a positive response but there are two facets of this survey that deserve special attention.

First, we have never had this magnitude of positive responses.  I think this reflects the common sense thinking of our supporters, people who would say, “Why in the world wouldn’t you test the medicine for all the conditions and do human trials like we have done for years.  Why wouldn’t you have a different name to reduce confusion and tell everyone if the medicine is changed?”  It just made sense to them.

The second facet that was especially interesting is the written comments we received.  Again, the large number of people that responded is unprecedented.  Here are two representative comments;

  • One person said, “No medication should be substituded (sic) without the PERMISSION of the patient.  People should have information so they may make an informed decision regarding their health and medications.”
  • Another person said, “I have had problems with a header generic drug that did not have the expensive catalyst that helped the body absorb it correctly. It did not work At All!  What can we expect of a “biosimilar“!”

As you can see these people are concerned.

Americans trust the FDA.  As a voice for the people you protect we ask that the FDA issues final guidance on these key issues and that Congress conducts appropriate oversight before the FDA gives final approval to the first biosimilar.   To do otherwise will undermine patient confidence.

Thank you.