FDA ConneKTion

Timely updates and insights on the latest issues affecting FDA-regulated companies from Kilpatrick Townsend

Archive for December 2015

Posted on Friday, December 11 2015 at 8:58 pm by -

Amgen v. Apotex: 180-Day Advance Notice of Biosimilar Marketing is Mandatory

By: Alyson L. Wooten, Pharm.D. and Carolina M. Wirth

The Federal Circuit in July said in its Amgen-Sandoz decision that declining to share information under the biosimilars pathway “patent dance” made the 180-day advance-notice provision mandatory;1 however, it left open the possibility that agreeing to share information made the 180-day advance-notice provision optional. This week a Florida Federal District Court judge slammed the door on this possibility for Apotex in its biosimilar application for Neulasta® (pegfilgrastim).2 U.S. District Judge James I. Cohen found that notice is in fact always mandatory, concluding that optional compliance would “result in confusion and uncertainty, as well as inconsistent results, depending on which route a [biosimilar] applicant chooses to travel.” This is the first post Amgen-Sandoz decision further interpreting the patent disputes resolution procedures under the Biologics Price Competition and Innovation Act (BPCIA). If the District Court’s interpretation of the Affordable Care Act’s biosimilars pathway stands, the 12-year marketing exclusivity granted to brand-name biologics under the BPCIA will be extended by six months. Thus, as some have argued,3 resulting in a period of exclusivity longer than that intended under the BPCIA.
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Posted on Wednesday, December 9 2015 at 7:04 pm by -

Amgen Files First Marketing Authorization Application for Humira® in the EU

By: Alyson L. Wooten, Pharm.D.

Following Amgen’s U.S. biosimilar application for AbbVie’s Humira® (adalimumab) in late November, Amgen has now filed a Marketing Authorization Application for ABP 501, a biosimilar candidate to Humira®, with the European Medicines Agency (EMA). Amgen believes this submission is the first adalimumab biosimilar application submitted in the European Union (EU).

Humira® is indicated in Europe for use in adults with moderate to severe rheumatoid arthritis, severe active ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderate to severe chronic plaque psoriasis, active and progressive psoriatic arthritis, moderately to severely active Crohn’s Disease, moderately to severely active ulcerative colitis and active moderate to severe hidradenitis suppurativa.
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Posted on Tuesday, December 1 2015 at 5:11 pm by -

Amgen Files Application for Humira Biosimilar

By Jennifer Giordano-Coltart, Ph.D.

Amgen filed a biosimilar application for AbbVie’s Humira® (adalimumab) on November 25, 2015.  The application represents a number of firsts:  it is Amgen’s first application under the 351(k) licensure program of the Biologics Price Competition and Innovation Act (BPCIA), it is the first biosimilar application for Humira®, and it is the first biosimilar application for a monoclonal antibody. 
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