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IP LitigationLife Sciences

Amgen’s Humira Biosimilar Becomes the Fourth FDA Approved Biosimilar

September 27, 2016

IP LitigationLife Sciences

Amgen’s Humira Biosimilar Becomes the Fourth FDA Approved Biosimilar

September 27, 2016

Back to Fish's Litigation Blog

 

On Friday, September 23, the FDA approved its fourth biosimilar, Amgen’s biosimilar version of AbbVie’s Humira®. Amgen’s biosimilar, Amjevita®, has been approved for treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. (AMJEVITA Label – FDA.) Humira® was approved for treatment of these conditions back in 2002. Humira® is also approved for treatment of juvenile Crohn’s disease, hidradenitis suppurativa, and uveitis. (HUMIRA Label – FDA.) In 2015, Humira® accounted for $8.4 billion in revenue in the United States alone, with worldwide sales of over $14 billion.

The three other FDA approved biosimilars are Sandoz’s Zarxio® (filgrastim-sndz), Pfizer’s Inflectra® (infliximab-dyyb), and Sandoz’s Erelzi® (etanercept-szzs), and are summarized in the table below.

Biosimilar

(Manufacturer)

Biologic

(Manufacturer)

FDA Approval DateBiosimilar Code NameLaunch
Zarxio®

(Sandoz)

Neupogen®

(Amgen)

March 6, 2015Filgrastim-sndzSeptember 15, 2015
Inflectra®

(Pfizer)

 

Remicade®

(Johnson & Johnson)

April 5, 2016Infliximab-dyyb
Erelzi®

(Sandoz)

Enbrel®

(Amgen)

August 30, 2016Etanercept-szzs
Amjevita®

(Amgen)

Humira®

(AbbVie)

September 23, 2016Adalimumab-atto

Amjevita® is the subject of ongoing litigation in the U.S. District Court for the District of Delaware (Civ. No. 16-666-SLR). Of note, Amgen is the biosimilar manufacturer here, though it has litigated and is litigating many other cases as the reference product sponsor. In this litigation, AbbVie is seeking an injunction to prevent Amgen from selling Amjevita®. AbbVie identified 61 patents it asserts that Amgen infringed with Amjevita®, but for procedural reasons due to the patent dance of the BPCIA, the initial phase of litigation has been limited to ten patents. (See Counterclaims and Answer of Defendants-Counterclaim Plaintiffs Amgen Inc. and Amgen Manufacturing Ltd. at 7-9, citing Amgen Inc. v. Apotex Inc., No. 2016-1308, slip op. at 6, 18 (Fed. Cir. July 5, 2016).) However, AbbVie stated in its complaint that “if and when Amgen provides its 180 day Notice of Commercial Marketing, and as circumstances otherwise warrant, AbbVie will assert the remainder of the patents.” (Complaint at 4.) AbbVie’s complaint also alleges that Amgen will refuse to comply with its Notice of Commercial Marketing obligations.  Amgen has disputed these allegations, claiming they are “baseless” because “Amgen intends to fully comply with its obligations under 42 U.S.C. §262(l)(8)(A).” (Counterclaims and Answer at 9.) Given Amjevita®’s recent FDA approval, Amgen’s promise to comply with the 180 day notice provision would push release of Amgevita® until at least March 2017.

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

Authors: Tasha Francis, Ph.D., Holly Chamberlain Rigby, Jenny Shmuel, Ph.D.


The opinions expressed are those of the authors on the date noted above 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 only and is not intended to be and should not be taken as legal advice. No attorney-client relationship is formed.

Related Tags

FDA
Amgen
biosimilar
AbbVie
Humira

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 has examined and...

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Tasha M. Francis, Ph.D. | Associate

Tasha Francis, Ph.D., practices intellectual property litigation with an emphasis on patent litigation. Her clients range from solo inventors and emerging companies in the biotechnology and biopharma industries to established international pharmaceutical companies. She has extensive...

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