Likelihood of Approval and Phase Transition Success Rate Model – Infliximab Biosimilar in Coronavirus Disease 2019 (COVID-19)

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This report provides you with the data that allows you to track and predict the specific likelihood of approval (LOA) and phase transition success rate (PTSR) of a drug using GlobalData’s proprietary machine learning algorithms developed using over 10 years of historical data.

Infliximab Biosimilar in Coronavirus Disease 2019 (COVID-19) Drug Details:

Infliximab biosimilar (Remsima, Inflectra, Flixceli, Emisima, Remsima SC, Infliximab BS, Remsima Pen) is a recombinant chimeric, human monoclonal antibody. It is composed of human constant and murine variable regions. Infliximab is produced by a recombinant cell line cultured by continuous perfusion. It is formulated as injectable solution and injectable powder for concentrate solution for intravenous and subcutaneous route of administration. Remsima, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate, adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs, for the treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies, for the treatment of fistulising, extracorporeal fistula, active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy),  for treatment of severe, active Crohn’s disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies, for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies, for treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies, for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy, for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Remsima should be administered in combination with methotrexate or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated, for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA).Inflectra is indicated for reduction of signs and symptoms and induction and maintenance of clinical remission in pediatric patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Inflectra is also indicated for reduction of signs and symptoms, induction and maintenance of clinical remission, and induction of mucosal healing in pediatric patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy. it is also indicated for the refractory uveitis due to Behcet’s disease.CT-P13 (infliximab biosimilar) is under development for the treatment of rheumatoid arthritis (RA) and coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is administered by subcutaneous route.

Report Coverage

The data is segmented by drug name per indication and shows the current likelihood of approval for the drug compared to the indication benchmark and the industry benchmark.

The Likelihood of Approval data is updated regularly based on events that take place which impact the clinical development process and regulatory considerations. GlobalData’s proprietary machine learning models consider these events in real time, to produce quantitative changes to the LOA and PTSR along with qualitative reasoning why the likelihood of approval has changed.

Quick View – Infliximab Biosimilar LOA Data
Report Segments	· Drug type · Intervention type
Drug Name	· Infliximab Biosimilar
Administration Pathway	· Intravenous| Subcutaneous
Therapeutic Areas	· Gastrointestinal| Immunology| Infectious Disease| Musculoskeletal Disorders| Ophthalmology
Key Manufacturers	· Celltrion Inc
Drug Development Status	· Marketed

Reasons to Buy

• Precise Likelihood of Approval and Phase Transition Success Rates: Our machine learning and proprietary models provide accurate predictions, helping you gauge the potential success of a drug in the regulatory process.
• Competitive Strategy Planning: Access information on LOA and PTSR for competitors’ drugs, allowing you to plan your clinical development, commercialisation and marketing strategies
• Event-driven Updates: Track event-driven changes in LOA and PTSR benchmarked against indication LOA/PTSR. Get the latest insights to adapt your strategies promptly!
• Well-informed Investment Decisions: This data helps you navigate the dynamic landscape of drug development and regulatory considerations.

Scope

• Drug Details: Drug name, Drug type, Intervention type
• Administration Pathway
• Therapeutic Areas
• Key Manufacturers
• Drug Development Status

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