Remicade® (infliximab)

BL 103772

Remicade® (infliximab)

BL 103772

U.S. License Holder:

Centocor Inc. (Janssen Biotech, Inc.)

Date of License:

August-24-1998

Last Update:

November-30-2018

approved_indications 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 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 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 patients with moderately to severely active disease;

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

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

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.

approved_indications 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)

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In Canada

Inflectra (Hospira) (January-2014)
Remsima (Celltrion) (January-2014)
SB2 (Samsung Bioepis) (December-2017)

Biosimilars Approved In The E.U.

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

Biosimilars Approved In Australia

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

Biosimilars Approved In Japan

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

Biosimilars Approved In South Korea

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

approved_indications U.S. Patent Litigations

PACER

Case No(s):

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

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
Case Terminated

BPCIA
N

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
Case Ongoing

BPCIA
N

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
Case Ongoing; Appeal Dismissed as Moot ('471 Patent Claims Found Unpatentable in Reexam)

BPCIA
Y

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

Plaintiffs
Janssen Biotech, Inc.

Defendants
Hyclone Laboratories, Inc.

Status
Case Stayed Pending Outcome of 1:16-cv-11117 (D. Mass.)

BPCIA
N

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
N

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
Case Ongoing

BPCIA
Y

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

related articles Related News Articles


Venable Fitzpatrick’s BiologicsHQ Monthly Injection – January 2018 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. February 7, 2018
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – August/September 2017 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. October 5, 2017
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – July 2017 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. July 26, 2017
The FDA Approves Zarxio® Opening the Door to the U.S. Biosimilars Market Robert S. Schwartz, Ph.D.; Corinne E. Atton March 6, 2015

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.

Disclaimer

The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

Subscribe for Future Updates

captcha