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Details:
Zymfentra (infliximab) a TNF alpha inhibitor, is the first and only FDA-approved SC formulation, for adults with moderately to severely active ulcerative colitis and crohn’s disease.
Lead Product(s): Infliximab
Therapeutic Area: Gastroenterology Product Name: Zymfentra
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 21, 2024
Details:
Remsima (infliximab) blocks the action of TNF-alpha. It is approved for maintenance therapy in adults with moderately to severely active ulcerative colitis and crohn’s disease.
Lead Product(s): Infliximab
Therapeutic Area: Gastroenterology Product Name: Remsima
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 18, 2024
Details:
CT-P13 SC is the world’s first subcutaneous formulation of infliximab. A 120 mg fixed dose of CT-P13 SC has been approved for use in the European Union (EU), in adults regardless of body weight, in both existing and newly added indications.
Lead Product(s): Infliximab
Therapeutic Area: Gastroenterology Product Name: Remsima
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 22, 2022
Details:
Under a prior Memorandum of Understanding, the anti-TNF infliximab, Remsima (a biosimilar of Remicade), approved for use in the U.K., will be supplied for trial by Celltrion Healthcare UK Limited. The University of Oxford and Celltrion are currently completing contract terms.
Lead Product(s): Infliximab
Therapeutic Area: Neurology Product Name: Remsima
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: National Institute for Health and Care Research
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Funding July 27, 2022
Details:
Formulating infliximab as an oral capsule – which must survive the digestive system's harsh environment and reach the colon intact – is transformational.
Lead Product(s): Infliximab
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: SGS Life Sciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration July 18, 2022
Details:
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: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2022
Details:
Data from the RTDM study show infliximab drug levels are stable across a 14-day treatment cycle for Crohn’s disease patients in remission, under maintenance therapy with Remsima SC, enabling therapeutic drug monitoring to be performed at any time between the two SC injections.
Lead Product(s): Infliximab
Therapeutic Area: Gastroenterology Product Name: Remsima
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 18, 2022
Details:
Under the MOU with Celltrion Healthcare, supply of anti-TNF biosimilar drug used in the ongoing development for new indications including the first antibody biosimilar, Remsima®, infliximab for major autoimmune disorders such as rheumatoid arthritis and ulcerative colitis.
Lead Product(s): Infliximab
Therapeutic Area: Musculoskeletal Product Name: Remsima
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Celltrion
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement September 20, 2021
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: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 07, 2021
Details:
The recommended new posology is to start Remsima® SC 120mg weekly up to week 4 and inject every 2 weeks thereafter; For patients currently on infliximab IV, Remsima® SC can be administered after 8 weeks from last dose without additional IV loading.
Lead Product(s): Infliximab
Therapeutic Area: Immunology Product Name: Remsima
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2021
Details:
The three drugs are Janssen’s infliximab (Remicade), Bristol Myers Squibb’s (BMS) abatacept (Orencia) and AbbVie’s investigational late-stage drug Cenicriviroc (CVC).
Lead Product(s): Infliximab,Abatacept,Cenicriviroc
Therapeutic Area: Infections and Infectious Diseases Product Name: Remicade
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 16, 2020
Details:
The positive CHMP opinion recommends expanding the marketing authorisation for the subcutaneous (SC) formulation of Remsima® for use in an additional five indications, including for the treatment of inflammatory bowel disease (IBD) and ankylosing spondylitis.
Lead Product(s): Infliximab
Therapeutic Area: Immunology Product Name: Remsima
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 28, 2020
Details:
1-year data from a randomised controlled trial in patients with rheumatoid arthritis (RA) show no impact of body mass index (BMI) on clinical response to subcutaneous infliximab (Remsima® SC / CT-P13 SC).
Lead Product(s): Infliximab
Therapeutic Area: Immunology Product Name: Remsima
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 04, 2020
Details:
The results from a randomised controlled trial showed that the subcutaneous formulation of infliximab was comparable to the intravenous formulation of CT-P13 in terms of efficacy and safety.
Lead Product(s): Infliximab
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2020