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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. (AbbVie Full-Year 2015 Financial Results.)

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 Date Biosimilar Code Name Launch
Zarxio®

(Sandoz)

Neupogen®

(Amgen)

March 6, 2015 Filgrastim-sndz September 15, 2015
Inflectra®

(Pfizer)

 

Remicade®

(Johnson & Johnson)

April 5, 2016 Infliximab-dyyb
Erelzi®

(Sandoz)

Enbrel®

(Amgen)

August 30, 2016 Etanercept-szzs
Amjevita®

(Amgen)

Humira®

(AbbVie)

September 23, 2016 Adalimumab-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.

Related Tags

FDA
Amgen
biosimilar
AbbVie
Humira

Blog Authors

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Holly Chamberlain | Associate

Holly Chamberlain is an Associate in the Boston office of Fish & Richardson. Ms. Chamberlain’s practice focuses on patent prosecution in a variety of areas including the biomedical, mechanical, and electromechanical arts. She was previously a...

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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...

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Tasha M. Francis, Ph.D. | Associate

Tasha Francis, Ph.D. is 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...

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