CSBio CSBio

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(adalimumab-bwwd), a Biosimilar to Humira\u00ae","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"November 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Samsung Bioepis"}]

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            Hadlima (adalimumab-bwwd), a biosimilar of Humira (adalimumab), is a TNF blocker indicated to treat Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa. Yusimry will be the first biologic product offered by the Cost Plus Drugs.

            Lead Product(s): Adalimumab-bwwd

            Therapeutic Area: Immunology Product Name: Hadlima

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Organon

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 07, 2023

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            Yuflyma (adalimumab-aaty) is the world’s first proposed high-concentration, low-volume and citrate-free adalimumab biosimilar to receive European Commission approval in Europe. Yuflyma is FDA approved for the treatment of autoimmune conditions.

            Lead Product(s): Adalimumab-aaty

            Therapeutic Area: Immunology Product Name: Yuflyma

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 03, 2023

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            Yuflyma (adalimumab-aaty) is the world’s first proposed high-concentration, low-volume and citrate-free adalimumab biosimilar to receive European Commission approval in Europe. Yuflyma is FDA approved for the treatment of autoimmune conditions.

            Lead Product(s): Adalimumab-aaty

            Therapeutic Area: Immunology Product Name: Yuflyma

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 24, 2023

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            HADLIMA (Adalimumab-bwwd) is a biosimilar product of HUMIRA®, formulated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritisetc. The drug bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface.

            Lead Product(s): Adalimumab

            Therapeutic Area: Immunology Product Name: Hadlima

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 03, 2023

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            Approval of citrate-free, high-concentration HADLIMA™ (adalimumab-bwwd), TNF blocker indicator was based on clinical data from study that compare PK, safety, tolerability, and immunogenicity of two formulations of HADLIMA (100 mg/mL vs 50 mg/mL) in healthy volunteers.

            Lead Product(s): Adalimumab,Methotrexate

            Therapeutic Area: Immunology Product Name: Hadlima

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Organon

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 17, 2022

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            Results Remsima (infliximab), showed a statistically significant difference in favour of SC compared to IV-treated patients at week 30 in almost all clinical variables, including low disease activity rates and remission rate.

            Lead Product(s): Infliximab

            Therapeutic Area: Immunology Product Name: Remsima

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 01, 2022

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            The Phase 1 clinical trial compares the pharmacokinetic (PK), safety, and tolerability profile of the new SB5 formulation having Adalimumab (40 mg/0.4 mL) with the original SB5 formulation (40 mg/0.8 mL) in healthy male subjects.

            Lead Product(s): Adalimumab

            Therapeutic Area: Immunology Product Name: Imraldi

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Biogen

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 01, 2022

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            Details:

            Remsima™ SC is the first and only subcutaneous form of infliximab to patients, payers and clinicians in Canada. Remsima™ SC offers an innovative treatment option for patients living with chronic inflammatory conditions in Canada.

            Lead Product(s): Infliximab

            Therapeutic Area: Immunology Product Name: Remsima

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 07, 2021

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            Details:

            Phase III study has demonstrated therapeutic equivalence of CT-P17 to reference adalimumab in 648 patients with active moderate-to-severe RA, despite methotrexate treatment who were randomised to receive either 40mg of CT-P17 or reference adalimumab every 2 weeks upto week 24.

            Lead Product(s): Adalimumab

            Therapeutic Area: Immunology Product Name: Yuflyma

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 01, 2021

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            Details:

            CT-P17 is the first proposed high-concentration, low-volume and citrate-free adalimumab biosimilar. One-year data have shown equivalent efficacy and comparable safety for Yuflyma™ against reference adalimumab in patients with moderate-to-severe active rheumatoid arthritis.

            Lead Product(s): Adalimumab

            Therapeutic Area: Immunology Product Name: Yuflyma

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 01, 2021

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