GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Infliximab biosimilar overview

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.

Celltrion overview

Celltrion is a biopharmaceutical company that focuses on the research, development, and manufacture of biosimilars and novel biopharmaceuticals. The company offers monoclonal antibodies for the treatment of rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, adult Crohn’s disease, psoriatic arthritis, and psoriasis. Its pipeline portfolio spans monoclonal antibody biosimilars for the treatment of rheumatoid arthritis; colorectal cancer; and respiratory disease; and antibody biologics and vaccines for infectious diseases such as hepatitis B, influenza, rabies, breast cancer, and seasonal influenza. Celltrion develops drugs by using its bioengineering and mammalian cell-culture technology. The company also carries out contract manufacturing of biosimilars. It has an operational presence in Korea, Russia, the UK, and the US. Celltrion is headquartered in Incheon, South Korea.

For a complete picture of Infliximab biosimilar’s drug-specific PTSR and LoA scores, buy the report here.

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.