Remsima (Infliximab) Monoclonal Antibody 2022
Celltrion Healthcare's Remsima (Inflectra) (INN: Infliximab) is an anti-inflammatory medicine that contains the active substance infliximab. It is the world's first biosimilar chimeric human-murine IgG1 monoclonal antibody (mAbs) produced in murine hybridoma cells by recombinant DNA technology used to treat several autoimmune diseases. Remsima slows down the disease progression by neutralizing tumor necrosis factor-alpha (TNF-a), a common cause of autoimmune diseases.
The U.S. FDA approves a biosimilar product based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product.
In August 2020, Celltrion and Inhalon Biopharma signed a Confidential Disclosure and Material Transfer Agreement to research and developed an inhaled administration formulation of regdanvimab. To elicit potent neutralizing antibody response against the new emerging SARS-CoV-2 variants, Celltrion identified a total of 38 potent neutralizing antibodies in which antibody candidate No. 32 (CT-P63) produced high neutralization titres against new emerging strains. CT-P63 has previously been demonstrated to have neutralizing activity against the most common variants, including the Alpha, Beta, Gamma, and Delta variants.
As of March 12, 2022, Remsima is Approved for various indications in Korea, Europe, Canada, Japan, the U.S., and multiple countries. U.S. FDA: BLA 125544. The EMA authorized Remsina EMEA/H/C/002576 in 2013. ATC code: L04AB02.
Located in Incheon, South Korea, Celltrion Healthcare, Inc. is committed to delivering innovative and affordable medications to promote patients' access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the U.S. FDA cGMP and the E.U. GMP guidelines. For more information, please visit https://www.celltrionhealthcare.com/en-us.
Remsima®SC
Remsima®SC is the world's first S.C. formulation of biosimilar infliximab developed by Celltrion. It was approved by the European Medicines Agency, the Korean Ministry of Food and Drug Safety, and Health Canada.
Remsima (Infliximab) Monoclonal Antibody Indication
Remsima is indicated to treat many different autoimmune diseases, including Rheumatoid Arthritis (R.A.), Ankylosing Spondylitis(AS), Ulcerative Colitis(U.C.), Crohn's disease(CD), Psoriatic Arthritis(PsA), Psoriasis(PsO).
Remsima (Infliximab) Monoclonal Antibody Dosage
Infliximab should be administered intravenously over two hours. All patients administered infliximab are to be observed for at least 1-2 hours post-infusion for acute infusion-related reactions. One vial contains 100 mg of infliximab. After reconstitution, each mL contains 10 mg of infliximab.
Rheumatoid arthritis: 3 mg/kg given as an intravenous infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every eight weeks thereafter. Remsima must be given concomitantly with methotrexate.
However, specific studies of infliximab in elderly patients have not been conducted.
Remsima (Infliximab) Monoclonal Antibody Contraindications
Contraindications Hypersensitivity to the active substance, to other murine proteins, or to any of the excipients listed in section 6.1. Patients with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections (see section 4.4). Patients with moderate or severe heart failure (NYHA class III/IV)
Regdanvimab (CT-P59) and CT-P63 Inhaled COVID-19 Therapy
Regdanvimab (CT-P59) and CT-P63 have been developed to target newly emerging mutations of SARS-CoV-2, including the Omicron variant (B.1.1.529). CT-P63 is a monoclonal antibody targeting the SARS-CoV-2 spike receptor-binding domain (RBD) as a treatment for COVID-19 infection.
The inhaled formulation of the monoclonal antibody not only targets the SARS-CoV-2 spike receptor-binding domain (RBD) and elicits a neutralizing antibody response, but it also has a 'trapping' mechanism of action and thereby neutralizes and traps in mucus with exceptional potency. The muco-trapping antibody platform directly traps the virus in airway mucus, preventing the local spread of the infection and quickly eliminating the virus from the lungs through the body's natural ability to clear mucus. In addition, the inhaled formulation can be readily self-administered by patients through a nebulizer, extend critical drug supplies to more patients by reducing the dosage needed, and does not place excessive demands on healthcare staff and infusion clinic space that intravenous drugs do.
Regkirona Monoclonal Antibody for COVID-19
Regkirona binds to the receptor-binding domain (RBD) of the spike(s) protein of SARS-CoV-2, consequently blocking cellular entry and SARS-CoV-2 infection. Regkirona is approved under Emergency Use of Authorization or Conditional Marketing Authorization in Korea, Europe, Indonesia, Brazil, Peru, and Australia.
Regkirona, Remsima Monoclonal Antibody News
February 7, 2022 - Celltrion Group announced it submitted an Investigational New Drug application to conduct a global Phase III clinical trial (2,200 people) evaluating the efficacy and safety of an inhaled COVID-19 antibody cocktail therapy for patients with mild-to-moderate symptoms of COVID-19. The inhaled COVID-19 antibody cocktail combines monoclonal antibodies with regdanvimab (CT-P59) and CT-P63 and has been developed to target newly emerging mutations of SARS-CoV-2, including the Omicron variant.
January 3, 2022 - The Celltrion Group announced results for its cocktail therapy candidates, including neutralization data against the Omicron variant. In an experiment conducted in partnership with the U.S. National Institutes of Health, CT-P63 showed strong neutralizing activity against the Omicron variant (B.1.1.529) based on structural analysis by X-ray crystallography and neutralization data from pseudo- virus testing. Celltrion anticipates results of the SARS-CoV-2 Omicron variant assays and animal model studies by the end of the first quarter of 2022.
July 22, 2021 - North Carolina-based Inhalon Biopharma, Inc., a clinical-stage immunotherapy company developing an inhaled "muco-trapping" antibody platform for treating a variety of acute respiratory infections, today announced it is partnering with Celltrion, Inc. to develop IN-006, an inhaled form of regdanvimab, for treating patients with COVID-19.
Remsima Monoclonal Antibody Clinical Trials
Remsima has been involved in over 25 clinical trials. Additionally, several other versions of the mABs are in COVID-19 six clinical trials.
A global Phase III clinical trial evaluating the efficacy and safety of an inhaled COVID-19 antibody cocktail therapy for patients with mild-to-moderate symptoms of COVID-19. The trial is expected to enroll 2,200 patients globally.
