Remicade® — Venable's BiologicsHQ

U.S. License Holder:

Centocor Inc. (Janssen Biotech, Inc.)

Date of License:

August-24-1998

Last Update:

Apr-15-2024

FDA-Approved Indications

REMICADE (infliximab) is a tumor necrosis factor (TNF) blocker indicated for:

Crohn's Disease: reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy; reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease;

Pediatric Crohn's Disease: reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy;

Ulcerative Colitis: reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy;

Pediatric Ulcerative Colitis: reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy;

Rheumatoid Arthritis in combination with methotrexate: reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active disease;

Ankylosing Spondylitis: reducing signs and symptoms in adult patients with active disease;

Psoriatic Arthritis: reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients;

Plaque Psoriasis: treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

aBLA / 505(b)(2) Activity

aBLA / 505(b)(2) Approved by FDA

Inflectra®: Celltrion (April-2016) Renflexis®: Samsung Bioepis Co., Ltd. (April-2017) Ixifi: Pfizer (December-2017) Avsola®: Amgen (December-2019) Zymfentra (subcutaneous, approved using full BLA): Celltrion (October-2023)

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Avsola® (Amgen) (March-2020)
Inflectra (Hospira) (January-2014)
Remsima (Celltrion) (January-2014)
Remsima SC (Celltrion) (February-2021)
Renflexis (Samsung Bioepis) (March-2018)

Biosimilars Approved In The E.U.

Flixabi (Samsung Bioepsis) (May-2016)
Inflectra (Hospira) (September-2013)
Remsima (Celltrion) (September-2013)
Remsima SC (Celltrion) (November-2019)
Zessly (Sandoz) (May-2018)

Biosimilars Approved In Australia

Inflectra / Remsima / Emisima / Flixceli (Hospira / Pharmbio) (August-2015)
Renflexis (Samsung Bioepis / Merck) (November-2016)

Biosimilars Approved In Japan

Infliximab BS (Remsima) (Celltrion / Nippon Kayaku) (July-2014)
Infliximab BS 2 (NI-071) (Nichi-Iko) (September-2017)
Infliximab BS 3 (Pfizer) (July-2018)

Biosimilars Approved In South Korea

Remaloce (Samsung Bioepis / Merck) (December-2015)
Remsima (Celltrion) (July-2012)

U.S. Patent Litigations

PACER

Case No(s):

1:14-cv-02256 (S.D.N.Y.)

U.S. Patent Nos.
7,846,442 (Methods of Treating Rheumatoid Arthritis with an Anti-TNFa Antibodies and Methotrexate) 8,298,537 (Concomitant Treatment of Rheumatoid Arthritis with Anti-TNF-alpha Antibodies and Methotrexate) 8,383,120 (Concomitant Treatment of Rheumatoid Arthritis with Anti-TNF-alpha Antibodies and Methotrexate)

Plaintiffs
Celltrion Healthcare Co., Ltd.; Celltrion Inc.

Defendants
The Kennedy Trust For Rheumatology Research

Status
Dismissed for Lack of Subject Matter Jurisdiction

BPCIA
N

1:14-cv-07049 (S.D.N.Y.)

U.S. Patent Nos.
6,284,471 (Anti-TNFa Antibodies and Assays Employing Anti-TNFa Antibodies) 7,223,396 (Methods of Treatment of Fistulas in Crohn's Disease with Anti-TNF Antibodies) 7,846,442 (Methods of Treating Rheumatoid Arthritis with an Anti-TNF-alpha Antibodies and Methotrexate) 8,298,537 (Concomitant Treatment of Rheumatoid Arthritis with Anti-TNF-alpha Antibodies and Methotrexate) 8,383,120 (Concomitant Treatment of Rheumatoid Arthritis with Anti-TNF-alpha Antibodies and Methotrexate)

Plaintiffs
Hospira, Inc.

Defendants
Janssen Biotech, Inc.; New York University; NYU Langone Medical Center; The Kennedy Trust For Rheumatology Research

Status
Dismissed for Lack of Subject Matter Jurisdiction

BPCIA
N

1:14-cv-11613 (D. Mass.)

U.S. Patent Nos.
5,919,452 (Methods of Treating TNFa-Mediated Disease using Chimeric Anti-TNF Antibodies) 6,284,471 (Anti-TNFa Antibodies and Assays Employing Anti-TNFa Antibodies) 7,223,396 (Methods of Treatment of Fistulas in Crohn's Disease with Anti-TNF Antibodies)

Plaintiffs
Celltrion Healthcare Co., Ltd.; Celltrion, Inc.

Defendants
Janssen Biotech, Inc.

Status
Voluntarily Dismissed

BPCIA
N

1:15-cv-10698 (D. Mass.)

U.S. Patent Nos.
5,807,715 (Methods and Transformed Mammalian Lymphocyte Cells for Producing Functional Antigen-Binding Protein including Chimeric Immunoglobulin) 6,284,471 (Anti-TNFa Antibodies and Assays Employing Anti-TNFa Antibodies) 6,773,600 (Use of a Clathrate Modifier to Promote Passage of Proteins during Nanofiltration) 6,900,056 (Chemically Defined Medium for Cultured Mammalian Cells) 7,223,396 (Methods of Treatment of Fistulas in Crohn's Disease with Anti-TNF Antibodies) 7,598,083 (Chemically Defined Media Compositions)

Plaintiffs
New York University; Janssen Biotech, Inc.

Defendants
Celltrion, Inc.; Celltrion Healthcare Co., Ltd.; Hospira Inc.

Federal Circuit Appeal(s)
17-1120

Status
Partial Judgment: '471 Patent Claims Invalid for Obviousness-Type Double Patenting, Appeal Dismissed as Moot ('471 Patent Claims Found Unpatentable in Reexam); Stipulated Dismissals on Remaining Patents

BPCIA
Y

1:16-cv-00071 (N.D. Utah)

U.S. Patent Nos.
7,598,083 (Chemically Defined Media Compositions)

Plaintiffs
Janssen Biotech, Inc.

Defendants
Hyclone Laboratories, Inc.

Status
Stipulated Dismissal

BPCIA
N

1:16-cv-11117 (D. Mass.)

U.S. Patent Nos.
7,598,083 (Chemically Defined Media Compositions)

Plaintiffs
Janssen Biotech, Inc.

Defendants
Celltrion, Inc.; Celltrion Healthcare Co., Ltd.; Hospira Inc.

Status
Dismissed

BPCIA
Y

1:17-cv-11008 (D. Mass.)

U.S. Patent Nos.
7,598,083 (Chemically Defined Media Compositions)

Plaintiffs
Janssen Biotech, Inc.

Defendants
Celltrion, Inc.; Celltrion Healthcare Co., Ltd.; Hospira Inc.

Federal Circuit Appeal(s)
18-2321; 18-2350 (Cross-Appeal)

Status
Summary Judgment of Noninfringement Granted; Federal Circuit Affirmed

BPCIA
Y

2:17-cv-03524 (D.N.J.)

U.S. Patent Nos.
6,773,600 (Use of a Clathrate Modifier to Promote Passage of Proteins during Nanofiltration) 6,900,056 (Chemically Defined Medium for Cultured Mammalian Cells) 7,598,083 (Chemically Defined Media Compositions)

Plaintiffs
Janssen Biotech, Inc.

Defendants
Samsung Bioepis Co., Ltd.

Status
Dismissed

BPCIA
Y

Methodology

Information contained in the Venable 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 BiologicsHQ database.

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Remicade® (infliximab)

Remicade® (infliximab)

FDA-Approved Indications

aBLA / 505(b)(2) Activity

aBLA / 505(b)(2) Approved by FDA

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Biosimilars Approved In The E.U.

Biosimilars Approved In Australia

Biosimilars Approved In Japan

Biosimilars Approved In South Korea

U.S. Patent Litigations

Case No(s):

1:14-cv-02256 (S.D.N.Y.)

1:14-cv-07049 (S.D.N.Y.)

1:14-cv-11613 (D. Mass.)

1:15-cv-10698 (D. Mass.)

1:16-cv-00071 (N.D. Utah)

1:16-cv-11117 (D. Mass.)

1:17-cv-11008 (D. Mass.)

2:17-cv-03524 (D.N.J.)

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