Cyltezo® (adalimumab-adbm)

aBL 761058

Cyltezo® (adalimumab-adbm)

aBL 761058

U.S. License Holder:

Boehringer Ingelheim

Date of License:

August-25-2017

Last Update:

November-30-2018

approved_indications FDA-Approved Indications


CYLTEZO (adalimumab-abdm) is a tumor necrosis factor (TNF) blocker indicated for treatment of:

Rheumatoid Arthritis (RA): Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA;

Juvenile Idiopathic Arthritis (JIA): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 4 years of age and older;

Psoriatic Arthritis (PsA): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA;

Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS;

Adult Crohn's Disease (CD): Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab;

Ulcerative Colitis (UC): Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP);

Plaque Psoriasis (Ps): The treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In The E.U.

Cyltezo (Boehringer Ingelheim) (November-2017)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

U.S. Patent No.
8,889,135 (Methods of Administering Anti-TNF-Alpha Antibodies)

Patent Owner
AbbVie Biotechnology Ltd.

Petitioner(s)
Boehringer Ingelheim Corp.; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH and Co. KG; Boehringer Ingelheim Pharmaceuticals Inc.; Boehringer Ingelheim USA Corp.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
17-2362 (Consolidated with 17-2304)

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Ongoing

U.S. Patent No.
8,889,135 (Methods of Administering Anti-TNF-Alpha Antibodies)

Patent Owner
AbbVie Biotechnology Ltd.

Petitioner(s)
Boehringer Ingelheim Corp.; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH and Co. KG; Boehringer Ingelheim Pharmaceuticals Inc.; Boehringer Ingelheim USA Corp.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
17-2363 (Consolidated with 17-2304)

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Ongoing

approved_indications U.S. Patent Litigations

PACER

Case No(s):

U.S. Patent Nos.
8,926,975 (Method of Treating Ankylosing Spondylitis) 9,018,361 (Isolation and Purification of Antibodies Using Protein A Affinity Chromatography) 9,090,867 (Fed-batch Method of Making Anti-TNF-Alpha Antibody) 9,096,666 (Purified Antibody Composition) 9,255,143 (Methods for Controlling the Galactosylation Profile of Recombinantly-Expressed Proteins) 9,266,949 (Low Acidic Species Compositions and Methods for Producing and Using the Same) 9,272,041 (Formulation of Human Antibodies for Treating TNF-Alpha Associated Disorders) 9,546,212 (Methods of Administering Anti-TNF Alpha Antibodies)

Plaintiffs
AbbVie Biotechnology Ltd.; AbbVie Inc.

Defendants
Boehringer Ingelheim Fremont, Inc.; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharmaceuticals Inc.

Status
Case Ongoing

BPCIA
Y

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Methodology

Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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