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    15-Oct-2022
    29-May-2025
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    Drugs in Development

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    Fully Human Anti-TNFα Monoclonal Antibody HUMIRA® Obtains Additional Approval for High-Dose Regimen of Ulcerative Colitis in Adult Patients and for Ne...

    Details:

    HUMIRA® is a fully human anti-TNF-α monoclonal antibody, got additional approval for a highdose regimen in adult patients with ulcerative colitis and for a new regimen in pediatric patients.


    Lead Product(s): Adalimumab

    Therapeutic Area: Immunology Brand Name: Humira

    Study Phase: Approved FDFProduct Type: Antibody

    Sponsor: Eisai

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 27, 2021

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    AbbVie Inc

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    Lead Product(s) : Adalimumab

    Therapeutic Area : Immunology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Eisai

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Fully Human Anti-TNFα Monoclonal Antibody HUMIRA® Obtains Additional Approval for High-Dose Regi...

    Details : HUMIRA® is a fully human anti-TNF-α monoclonal antibody, got additional approval for a highdose regimen in adult patients with ulcerative colitis and for a new regimen in pediatric patients.

    Product Name : Humira

    Product Type : Antibody

    Upfront Cash : Inapplicable

    September 27, 2021

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    AbbVie's Humira Gets Approval In Canada for Treatment of Pediatric Patients With Ulcerative Colitis

    Details:

    HUMIRA (adalimumab) is the first and only subcutaneous biologic treatment option for pediatric patients from 5 years of age with moderately to severely active ulcerative colitis.


    Lead Product(s): Adalimumab

    Therapeutic Area: Immunology Brand Name: Humira

    Study Phase: Approved FDFProduct Type: Antibody

    Sponsor: Eisai

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 24, 2021

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    AbbVie Inc

    U.S.A
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    Lead Product(s) : Adalimumab

    Therapeutic Area : Immunology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Eisai

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    AbbVie's Humira Gets Approval In Canada for Treatment of Pediatric Patients With Ulcerative Coliti...

    Details : HUMIRA (adalimumab) is the first and only subcutaneous biologic treatment option for pediatric patients from 5 years of age with moderately to severely active ulcerative colitis.

    Product Name : Humira

    Product Type : Antibody

    Upfront Cash : Inapplicable

    April 24, 2021

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    HUMIRA® (adalimumab) Receives FDA Approval to Treat Pediatric Patients Living with Moderately to Severely Active Ulcerative Colitis

    Details:

    Approval for adalimumab based on results from the pivotal Phase 3 ENVISION I study showing the higher dosage of HUMIRA induced clinical remission in 60 percent of patients at Week 8 and 45 percent of patients, who responded at Week 8, were in remission at Week 52.


    Lead Product(s): Adalimumab

    Therapeutic Area: Immunology Brand Name: Humira

    Study Phase: Approved FDFProduct Type: Antibody

    Sponsor: Eisai

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable February 24, 2021

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    AbbVie Inc

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    Lead Product(s) : Adalimumab

    Therapeutic Area : Immunology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Eisai

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    HUMIRA® (adalimumab) Receives FDA Approval to Treat Pediatric Patients Living with Moderately to ...

    Details : Approval for adalimumab based on results from the pivotal Phase 3 ENVISION I study showing the higher dosage of HUMIRA induced clinical remission in 60 percent of patients at Week 8 and 45 percent of patients, who responded at Week 8, were in remission a...

    Product Name : Humira

    Product Type : Antibody

    Upfront Cash : Inapplicable

    February 24, 2021

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    Fresenius Kabi Enters Marketing Agreement For Biosimilar Product

    Details:

    Medac’s sales representatives will begin offering the adalimumab biosimilar IDACIO® as an additional therapy option to the rheumatologists and dermatologists they work with.


    Lead Product(s): Adalimumab

    Therapeutic Area: Immunology Brand Name: Idacio

    Study Phase: Approved FDFProduct Type: Antibody

    Sponsor: Fresenius Kabi

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement May 28, 2020

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    medac

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    Lead Product(s) : Adalimumab

    Therapeutic Area : Immunology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Fresenius Kabi

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Fresenius Kabi Enters Marketing Agreement For Biosimilar Product

    Details : Medac’s sales representatives will begin offering the adalimumab biosimilar IDACIO® as an additional therapy option to the rheumatologists and dermatologists they work with.

    Product Name : Idacio

    Product Type : Antibody

    Upfront Cash : Undisclosed

    May 28, 2020

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    FDA Grants Interchangeable Status to YUFLYMA, Celltrion’s Humira Biosimilar

    Details:

    Yuflyma (adalimumab) is a biosimilar to Humira approved for the treatment of adult rheumatoid arthritis, psoriasis, adult psoriatic arthritis.


    Lead Product(s): Adalimumab

    Therapeutic Area: Immunology Brand Name: Yuflyma

    Study Phase: Approved FDFProduct Type: Antibody

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 14, 2025

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    Celltrion

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    Lead Product(s) : Adalimumab

    Therapeutic Area : Immunology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    FDA Grants Interchangeable Status to YUFLYMA, Celltrion’s Humira Biosimilar

    Details : Yuflyma (adalimumab) is a biosimilar to Humira approved for the treatment of adult rheumatoid arthritis, psoriasis, adult psoriatic arthritis.

    Product Name : Yuflyma

    Product Type : Antibody

    Upfront Cash : Inapplicable

    April 14, 2025

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    Coherus BioSciences Divests YUSIMRY in $40 Million All Cash Transaction

    Details:

    Through the divestment, Coherus reinforces its strategic focus on oncology Yusimry (adalimumab) biosimilar to Humira. It is indicated for the treatment of Rheumatoid Arthritis.


    Lead Product(s): Adalimumab

    Therapeutic Area: Immunology Brand Name: Yusimry

    Study Phase: Approved FDFProduct Type: Antibody

    Sponsor: Hong Kong King-Friend Industrial Co. Ltd

    Deal Size: $40.0 million Upfront Cash: $40.0 million

    Deal Type: Divestment June 27, 2024

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    Coherus Biosciences

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    Lead Product(s) : Adalimumab

    Therapeutic Area : Immunology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Hong Kong King-Friend Industrial Co. Ltd

    Deal Size : $40.0 million

    Deal Type : Divestment

    DEALS_DEV arrow-down

    Coherus BioSciences Divests YUSIMRY in $40 Million All Cash Transaction

    Details : Through the divestment, Coherus reinforces its strategic focus on oncology Yusimry (adalimumab) biosimilar to Humira. It is indicated for the treatment of Rheumatoid Arthritis.

    Product Name : Yusimry

    Product Type : Antibody

    Upfront Cash : $40.0 million

    June 27, 2024

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    Boehringer Ingelheim Expands Access to Adalimumab-Adbm Injection for Humira

    Details:

    Boehringer Ingelheim will manufacture adalimumab-adbm for Quallent, continuing the commercialization of Boehringer Ingelheim-labeled Cyltezo.


    Lead Product(s): Adalimumab

    Therapeutic Area: Immunology Brand Name: Cyltezo

    Study Phase: Approved FDFProduct Type: Antibody

    Sponsor: Quallent Pharmaceuticals

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement May 13, 2024

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    Boehringer Ingelheim GmbH

    Germany
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    Boehringer Ingelheim GmbH

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    Lead Product(s) : Adalimumab

    Therapeutic Area : Immunology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Quallent Pharmaceuticals

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Boehringer Ingelheim Expands Access to Adalimumab-Adbm Injection for Humira

    Details : Boehringer Ingelheim will manufacture adalimumab-adbm for Quallent, continuing the commercialization of Boehringer Ingelheim-labeled Cyltezo.

    Product Name : Cyltezo

    Product Type : Antibody

    Upfront Cash : Undisclosed

    May 13, 2024

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    US Commercialization Deal with Quallent Aims to Reduce Patient Costs

    Details:

    Alvotech will manufacture its high-concentration interchangeable biosimilar, AVT02, a monoclonal antibody and that has been approved as a biosimilar to Humira (adalimumab) for Quallent.


    Lead Product(s): Adalimumab

    Therapeutic Area: Immunology Brand Name: AVT02

    Study Phase: Approved FDFProduct Type: Antibody

    Sponsor: Alvotech

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement April 30, 2024

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    08

    Quallent Pharmaceuticals

    Cayman Islands
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    ACS Fall 2025
    Not Confirmed

    Quallent Pharmaceuticals

    Cayman Islands
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    ACS Fall 2025
    Not Confirmed
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    Lead Product(s) : Adalimumab

    Therapeutic Area : Immunology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Alvotech

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    US Commercialization Deal with Quallent Aims to Reduce Patient Costs

    Details : Alvotech will manufacture its high-concentration interchangeable biosimilar, AVT02, a monoclonal antibody and that has been approved as a biosimilar to Humira (adalimumab) for Quallent.

    Product Name : AVT02

    Product Type : Antibody

    Upfront Cash : Undisclosed

    April 30, 2024

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    Alvotech Signs U.S. Agreement to Expand Access for High-Concentration Humira® Biosimilar

    Details:

    The agreement aims to further enhance access to Simlandi (adalimumab-ryvk) in the U.S. market, the newly U.S. FDA approved high-concentration interchangeable biosimilar to Humira.


    Lead Product(s): Adalimumab

    Therapeutic Area: Immunology Brand Name: Simlandi

    Study Phase: Approved FDFProduct Type: Antibody

    Sponsor: Undisclosed

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement April 19, 2024

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    09

    Alvotech

    Iceland
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    ACS Fall 2025
    Not Confirmed

    Alvotech

    Iceland
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    ACS Fall 2025
    Not Confirmed
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    Lead Product(s) : Adalimumab

    Therapeutic Area : Immunology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Alvotech Signs U.S. Agreement to Expand Access for High-Concentration Humira® Biosimilar

    Details : The agreement aims to further enhance access to Simlandi (adalimumab-ryvk) in the U.S. market, the newly U.S. FDA approved high-concentration interchangeable biosimilar to Humira.

    Product Name : Simlandi

    Product Type : Antibody

    Upfront Cash : Undisclosed

    April 19, 2024

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    Alvotech and Teva Announce U.S. Approval Of SIMLANDI® Injection, A Humira® Biosimilar

    Details:

    Simlandi (adalimumab) is the first interchangeable biosimilar to Humira for various arthritic conditions and Crohn’s disease.


    Lead Product(s): Adalimumab

    Therapeutic Area: Immunology Brand Name: Simlandi

    Study Phase: Approved FDFProduct Type: Antibody

    Sponsor: Teva Pharmaceutical Industries

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable February 23, 2024

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    10

    Alvotech

    Iceland
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    ACS Fall 2025
    Not Confirmed

    Alvotech

    Iceland
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    ACS Fall 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Adalimumab

    Therapeutic Area : Immunology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Teva Pharmaceutical Industries

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Alvotech and Teva Announce U.S. Approval Of SIMLANDI® Injection, A Humira® Biosimilar

    Details : Simlandi (adalimumab) is the first interchangeable biosimilar to Humira for various arthritic conditions and Crohn’s disease.

    Product Name : Simlandi

    Product Type : Antibody

    Upfront Cash : Inapplicable

    February 23, 2024

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