Year in Review: The Top-Five U.S. Market Developments of 2017

by Goodwin

Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017:

1.  Compared to three approvals in 2016, the FDA approved five biosimilar products in 2017:

  • Renflexis® (infliximab-abda)
  • Cyltezo® (adalimumab-adbm)
  • Mvasi® (bevacizumab-awwb)
  • Ogivri® (trastuzumab-dkst)
  • Ixifi® (infliximab-qbtx)

In a press release regarding the approval for Ogivri®, FDA Commissioner Scott Gottlieb, M.D., said:  “The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs. . . . We’re committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs.”

2.  The first biosimilar approved in 2017 was Samsung Bioepis’ Renflexis® (infliximib-abda), which is the second biosimilar of Janssen’s Remicade® to receive FDA approval.  Renflexis® launched in July, priced at a 35% discount to Remicade®, and remains the only biosimilar approved this year to become commercially available.  Although conclusions from a recent study supported switching patients from Remicade® to Renflexis®, in its third quarter earnings call Johnson & Johnson reported that sales for Remicade® have only decreased 1% in the U.S.  The company attributed much of the strength of Remicade® in the market to physicians being “very reluctant to switch stable patients for Remicade into other medicines” due to the “the body of data that supports using Remicade and the lack of interchangeability.”

3.  In March, while its aBLA was still pending review by FDA, Mylan announced that it had reached a settlement with Genentech and Roche, providing Mylan with global licenses to commercialize Ogivri® (trastuzumab-dkst).  Mylan’s Ogivri® was approved on December 1, 2017.   No expected launch date for Ogivri® has yet been publicized.

4.  Though approved, Cyltezo® (adalimumab-adbm, AbbVie v. BI) and Mvasi® (bevacizumab-awwb, Genentech v. Amgen) remain the subject of ongoing BPCIA litigation.  Neither Boehringer Ingelheim nor Amgen has announced planned launch dates.

5.  The last biosimilar approval of 2017 was Ixifi® (infliximab-qbtx) on December 13, 2017.  Ixifi® is Pfizer’s biosimilar to Remicade®, and became the third infliximab biosimilar to receive FDA approval.  Although no plans for launch have been announced, Pfizer also supplies Celltrion’s infliximab biosimilar Inflectra®, which launched in the U.S. in late 2016.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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