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IP LitigationLife Sciences

FDA Approves Sandoz's Biosimilar of Enbrel®

August 31, 2016

IP LitigationLife Sciences

FDA Approves Sandoz's Biosimilar of Enbrel®

August 31, 2016

Back to Fish's Litigation Blog

 

Yesterday, the FDA approved its third biosimilar product, Sandoz’s biosimilar version of Amgen’s Enbrel® (etanercept).  The drug, named Erelzi (etanercept-szzs), was approved for the same indications listed on Enbrel®’s label, including rheumatoid arthritis, psoriasis, and other immune system disorders.  The other two biosimilars the FDA has approved are Sandoz’s Zarxio® (filgrastim-sndz) biosimilar of Amgen’s Neupogen® and Pfizer’s Inflectra® (infliximab-dyyb) biosimilar of Johnson & Johnson’s Remicade®.

However, it may be some time before Erelzi enters the US market.  On February 26, 2016, Immunex Corp., Amgen Manufacturing and Hoffman-La Roche filed suit against Sandoz under the “patent dance” provisions of the Biologics Price Competitions and Innovation Act (“the BPCIA”), asserting five patents that cover etanercept.  While discovery is currently underway, on August 11, the court entered a consent preliminary injunction order, which prohibits Sandoz from making, using, importing, selling or offering to sell its biosimilar product.  Further details regarding the injunction are unavailable at this time since the stipulation that led to the injunction is sealed.  Trial regarding the validity of the five patents-in-suit is set for April 17, 2018.

Last year, Enbrel® accounted for approximately $5.36 billion of Amgen’s total product sales.  Interestingly, Amgen, the biologic manufacturer, in this case, has taken on the role of a biosimilar applicant, announcing plans to launch several biosimilars, including a biosimilar version of AbbVie’s drug Humira®.

We will continue to monitor activity in this area and provide updates.

 


The opinions expressed are those of the author(s) and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes and is not intended to be and should not be taken as legal advice.

Related Tags

biosimilar drug
Sandoz
Erelzi

Blog Authors

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Jenny Shmuel, Ph.D. | Associate

  Dr. Jenny Shmuel represents clients on a range of intellectual property matters, with an emphasis on medical device and pharmaceutical technologies. She has extensive experience in pre-suit diligence, case management, expert and fact discovery, and brief writing, and...

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Tasha M. Francis, Ph.D. | Associate

Tasha Francis, Ph.D., an associate in Fish & Richardson’s Twin Cities office, practices intellectual property litigation with an emphasis on patent litigation. Dr. Francis has represented plaintiffs and defendants in cases involving medical devices, biotechnology, and...

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