Search Team

Search by Last Name
A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
Y
Z
Banner image

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.

 

Related Tags

biosimilar drug
Sandoz
Erelzi

Blog Authors

Jenny Shmuel, Ph.D. | Associate

​Jenny Shmuel is an Associate in the Boston office of Fish & Richardson. She was a Summer Associate with the firm in 2011. Ms. Shmuel has worked on a range of intellectual property matters, including patent litigation in the software and medical device fields, copyright...

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...

Leave a Reply

Your email address will not be published. Required fields are marked *