Zimrixby (rituximab-cdxx)

aBL 761376

Zimrixby (rituximab-cdxx)

aBL 761376

U.S. License Holder:

Dr. Reddy's / Fresenius Kabi

Date of License:

July-31-2026

Last Update:

August-31-2026

approved_indications FDA-Approved Indications

ZIMRIXBY (rituximab-cdxx) is a CD20-directed cytolytic antibody indicated for the treatment of:

Adult patients with Non-Hodgkin's Lymphoma (NHL): Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent; Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy; Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens;

Adult patients with Chronic Lymphocytic Leukemia (CLL): Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide;

Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies;

Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Ituxredi® (Dr. Reddy's) (September-2024)

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:23-cv-22485 (D.N.J.)

U.S. Patent Nos.
7,485,704 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,976,838 (Therapy of Autoimmune Disease in a Patient with an Inadequate Response to a TNF-alpha Inhibitor) 8,460,895 (Method for Producing Recombinant Proteins with a Constant Content of pCO2 in the Medium) 8,512,983 (Production of Proteins in Glutamine-Free Cell Culture Media) 8,574,869 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides) 9,714,293 (Production of Proteins in Glutamine-free Cell Culture Media) 10,017,732 (Cell Culture Compositions with Antioxidants and Methods for Polypeptide Production) 10,336,983 (Method for Increasing the Specific Production Rate of Eukaryotic Cells) 10,450,379 (Method for Treating Joint Damage) 10,654,940 (Method for Treating Joint Damage) 10,662,237 (Method to Improve Virus Filtration Capacity) 10,676,710 (Cell Culture Compositions with Antioxidants and Methods for Polypeptide Production) 10,759,866 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides) 10,829,732 (Cell Culture Compositions with Antioxidants and Methods for Polypeptide Production) 10,982,003 (Production of Proteins in Glutamine-Free Cell Culture Media)

Plaintiffs
Genentech, Inc.; Biogen, Inc.; Hoffmann-La Roche Inc.

Defendants
Dr. Reddy's Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd.; Dr. Reddy's Laboratories, SA; Fresenius Kabi Deutschland GmbH; Fresenius Kabi SwissBioSim GmbH; Fresenius Kabi USA, LLC

Status
Settled

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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