Simlandi® (adalimumab-ryvk)

aBL 761299

Simlandi® (adalimumab-ryvk)

aBL 761299

U.S. License Holder:

Alvotech / Teva

Date of License:

February-23-2024 (High-Concentration, Interchangeable)

Last Update:

Apr-15-2024

approved_indications FDA-Approved Indications

SIMLANDI (adalimumab-ryvk) is a tumor necrosis factor (TNF)-blocker indicated for:

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 2 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;

Crohn’s Disease (CD): Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older;

Ulcerative Colitis (UC): Treatment of moderately to severely active ulcerative colitis in adult patients;

Plaque Psoriasis (Ps): 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;

Hidradenitis Suppurativa (HS): Treatment of moderate to severe hidradenitis suppurativa in adult patients;

Uveitis (UV): Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Simlandi® (Alvotech / JAMP) (January-2022)

Biosimilars Approved In The E.U.

Libmyris / Hukyndra (Stada Arzneimittel AG / Alvotech) (November-2021)

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:21-cv-02258 (N.D. Ill.)

U.S. Patent Nos.
8,420,081 (Antibody Formulations and Methods of Making Same) 8,926,975 (Method of Treating Ankylosing Spondylitis) 8,961,973 (Multiple-Variable Dose Regimen for Treating TNF-Alpha-Related Disorders) 9,085,619 (Anti-TNF Antibody Formulations)

Plaintiffs
AbbVie Biotechnology Ltd.; AbbVie Inc.

Defendants
Alvotech hf.

Status
Dismissed due to Settlement

BPCIA
Y

1:21-cv-02899 (N.D. Ill.)

U.S. Patent Nos.
6,805,686 (Autoinjector with Extendable Needle Protector Shroud) 8,231,876 (Purified Antibody Composition) 8,663,945 (Methods of Producing Anti-TNF-Alpha Antibodies in Mammalian Cell Culture) 8,708,968 (Removal of Needle Shields from Syringes and Automatic Injection Devices) 8,715,664 (Use of Human TNF Alpha Antibodies for Treatment of Erosive Polyarthritis) 8,808,700 (Use of TNF Alpha Inhibitor for Treatment of Erosive Polyarthritis) 8,883,156 (Purified Antibody Composition) 8,889,136 (Multiple-Variable Dose Regimen for Treating TNF Alpha-Related Disorders) 8,895,009 (Purified Antibody Composition) 8,906,372 (Purified Antibody Composition) 8,906,373 (Use of TNF-Alpha Inhibitor for Treatment of Psoriasis) 8,906,646 (Fed-Batch Method of Making Human Anti-TNF-Alpha Antibody) 8,911,737 (Methods of Administering Anti-TNF Alpha Antibodies) 8,911,964 (Fed-Batch Method of Making Human Anti-TNF-Alpha Antibody) 8,916,153 (Purified Antibody Composition) 8,961,974 (Multiple-Variable Dose Regimen for Treating TNF Alpha-Related Disorders) 8,974,790 (Methods of Administering Anti-TNF Alpha Antibodies) 8,986,693 (Use of TNF Alpha inhibitor for Treatment of Psoriasis) 8,992,926 (Methods of Administering Anti-TNF Alpha Antibodies) 8,999,337 (Methods for Treating Juvenile Idiopathic Arthritis by Inhibition of TNF Alpha) 9,061,005 (Multiple-Variable Dose Regimen for Treating Idiopathic Inflammatory Bowel Disease) 9,062,106 (Methods for Controlling the Galactosylation Profile of Recombinantly-Expressed Proteins) 9,067,992 (Use of TNF Alpha Inhibitor for Treatment of Psoriatic Arthritis) 9,085,618 (Low Acidic Species Compositions and Methods for Producing and Using the Same) 9,085,620 (Use of TNF Alpha Inhibitor for Treatment of Psoriatic Arthritis) 9,090,688 (Methods for Controlling the Galactosylation Profile of Recombinantly-Expressed Proteins) 9,090,689 (Use of TNF Alpha Inhibitor for Treatment of Psoriasis) 9,090,867 (Fed-Batch Method of Making Anti-TNF-Alpha Antibody) 9,096,666 (Purified Antibody Composition) 9,102,723 (Purified Antibody Composition) 9,150,645 (Cell Culture Methods to Reduce Acidic Species) 9,181,337 (Modulated Lysine Variant Species Compositions and Methods for Producing and Using the Same) 9,181,572 (Methods to Modulate Lysine Variant Distribution) 9,187,559 (Multiple-Variable Dose Regimen for Treating Idiopathic Inflammatory Bowel Disease) 9,234,032 (Fed-Batch Methods for Producing Adalimumab) 9,266,949 (Low Acidic Species Compositions and Methods for Producing and Using the Same) 9,273,132 (Purified Antibody Composition) 9,284,370 (Methods for Treating Juvenile Idiopathic Arthritis) 9,284,371 (Methods for Producing Adalimumab) 9,290,568 (Methods to Control Protein Heterogeneity) 9,315,574 (Low Acidic Species Compositions and Methods for Producing and Using the Same) 9,328,165 (Purified Antibody Composition) 9,334,319 (Low Acidic Species Compositions) 9,339,610 (Removal of Needle Shield from Syringes and Automatic Injection Devices) 9,346,879 (Protein Purification Methods to Reduce Acidic Species) 9,359,434 (Cell Culture Methods to Reduce Acidic Species) 9,499,614 (Methods for Modulating Protein Glycosylation Profiles of Recombinant Protein Therapeutics Using Monosaccharides and Oligosaccharides) 9,499,616 (Modulated Lysine Variant Species Compositions and Methods for Producing and Using the Same) 9,505,834 (Methods for Controlling the Galactosylation Profile of Recombinantly-Expressed Proteins) 9,512,216 (Use of TNF Alpha Inhibitor) 9,522,953 (Low Acidic Species Compositions and Methods for Producing and Using the Same) 9,546,212 (Methods of Administering Anti-TNF Alpha Antibodies) 9,550,826 (Glycoengineered Binding Protein Compositions) 9,624,295 (Uses and Compositions for Treatment of Psoriatic Arthritis) 9,669,093 (Methods for Treating Juvenile Idiopathic Arthritis) 9,683,033 (Cell Culture Methods to Reduce Acidic Species) 9,708,400 (Methods to Modulate Lysine Variant Distribution) 9,957,318 (Protein Purification Methods to Reduce Acidic Species) 11,083,792 (Purified Antibody Composition) 11,167,030 (Protein Formulations and Methods of Making Same) 11,191,834 (Protein Formulations and Methods of Making Same)

Plaintiffs
AbbVie Biotechnology Ltd.; AbbVie Inc.

Defendants
Alvotech hf.

Status
Dismissed due to Settlement

BPCIA
Y

1:21-cv-05645 (N.D. Ill.) (transferred from 2:21-cv-00265 (E.D. Va.))

U.S. Patent Nos.
8,420,081 (Antibody Formulations and Methods of Making Same) 8,926,975 (Method of Treating Ankylosing Spondylitis) 8,961,973 (Multiple-Variable Dose Regimen for Treating TNF-Alpha-Related Disorders) 9,085,619 (Anti-TNF Antibody Formulations)

Plaintiffs
Alvotech USA Inc.; Alvotech hf.

Defendants
AbbVie Biotechnology Ltd.; AbbVie Inc.

Status
Voluntarily Dismissed

BPCIA
N

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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