Weekly Roundup 1.9.15

The New Year has gotten off to a very chilly start here in Washington, D.C. But we have a new Congress that has been sworn in as the 114th.  I have cleared the Eye on FDA tab on the blog site to pave the way for new proposed legislation that would impact the FDA and the medical products industry. We are also poised for turning some additional corners at FDA as noted below.  And it is that time when we put our resolve to the test regarding our resolutions to make our own changes.

  • FDA’s ODAC Recommends Approval for Biosimilar -While generic chemical drugs have long been available, providing access to treatment at a reduced cost, the equivalent for biologic treatments has long been awaited.  As part of the Affordable Care Act, FDA has been constructing a regulatory pathway for the consideration and approval of biosimilars.  This week, a meeting of FDA’s Oncologic Drugs Advisory Committee (ODAC) considered an application to approve a drug that would be marketed as a biosimilar to Neupogen.  The panel voted 14-0 to recommend approval and if FDA accepts that recommendation and approves the drug, it would be the first biosimilar to enter the U.S. market. The proposed name for the new biosimilar for Neupogen is Zarxio and you can read additional media coverage of the meeting here and see the company press release here.
  • FDA Announces Ambitious List of Guidance Docs for 2015 – Each year FDA publishes a list of those guidance documents that it is aiming to put out for the year. It is a goal – some do not make it – and it is possible that there will be others not listed here that end up coming out.  In any case, there are a LOT of them and the list categorizes them.  It is notable that 6 are in the category of advertising, including one related to social media – Use of Links to Third Party Sites.  In addition, related to the story above, there are 4 related to biosimilars. Check it out.
  • Approval for Multiple Indications for Savaysa – The agency made its first approval announcement for 2015 for Savaysa, made by Daiichi Sankyo.  The anti-clotting drug was approved for multiple indications to reduce the risk of stroke and blood clots in patients with atrial fibrillation that is not caused by a heart valve problem and to treat deep vein thrombosis and pulmonary embolism in patients who have already been treated with an anti-clotting drug administered by injection or infusion for five to ten days. The drug comes with Boxed Warning and it will be dispensed with a Medication Guide.

That’s it for me this week folks.  Hope that 2015 has gotten off to a good start for you and remains so throughout the year.  And, if you are in one of the areas affected by extreme cold – stay warm and cozy up.

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