Infliximab

Celltrion receives European Commission approval of Omlyclo® (CT-P39), the first and only omalizumab biosimilar approved in Europe

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금요일, 5월 24, 2024
Health, Other Science, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Infliximab, Patient, Omalizumab, Pharmacokinetics, Immunology, Food, Sinusitis, European Medicines Agency, FDA, Polyp (medicine), Safety, Marketing, Asthma, Civil service commission, European Commission, CSU, EMA, Allergy, Committee, Biosimilar, CHMP, Pharmaceutical industry

Celltrion today announced that the European Commission (EC) has approved Omlyclo® (CT-P39), an omalizumab biosimilar referencing Xolair®.

Key Points: 
  • Celltrion today announced that the European Commission (EC) has approved Omlyclo® (CT-P39), an omalizumab biosimilar referencing Xolair®.
  • Omlyclo® is approved for the treatment of allergic asthma, chronic spontaneous urticaria (CSU), and chronic rhinosinusitis with nasal polyps (CRSwNP).
  • This is why we are pleased to receive the first EC approval for an omalizumab biosimilar in Europe, an important step towards improving patient access to treatment.
  • Omlyclo® is Celltrion’s sixth biosimilar, besides Remsima® SC, a subcutaneous formulation of infliximab, approved for use in the EU, following the approval of Remsima® (biosimilar infliximab), Truxima® (biosimilar rituximab), Herzuma® (biosimilar trastuzumab), Yuflyma® (biosimilar adalimumab), and Vegzelma® (biosimilar bevacizumab).

Biogen Receives Positive CHMP Opinion for TOFIDENCE™ (tocilizumab), a Biosimilar Referencing ROACTEMRA®

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목요일, 4월 25, 2024
BIIB, Biogen, Adalimumab, Methotrexate, Etanercept, Safety, Pharmacokinetics, European Commission, CHMP, Condylar resorption, Tocilizumab, European, Patient, Rheumatoid arthritis, EMA, Infliximab, Committee, Civil service commission, COVID-19, European Medicines Agency, Vaccine

CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE™ to the reference product ROACTEMRA®

Key Points: 
  • CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE™ to the reference product ROACTEMRA®
    CAMBRIDGE, Mass., April 25, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for TOFIDENCE™ (tocilizumab), a biosimilar monoclonal antibody referencing ROACTEMRA®1.
  • The CHMP’s positive opinion will now be referred to the European Commission (EC), which will decide whether to grant marketing authorization for TOFIDENCE.
  • “The positive CHMP recommendation for TOFIDENCE marks another positive step toward helping more people with inflammatory and immune-mediated conditions gain access to leading therapies,” said Ian Henshaw, Global Head of Biosimilars at Biogen.
  • Under the agreement, Biogen has exclusive regulatory, manufacturing, and commercial rights to TOFIDENCE in all countries excluding China (including Hong Kong, Macau and Taiwan).

Breakthroughs in Kexing Biopharm's Overseas Efforts: Qualification of Two Licensed Products for GMP Audits in Egypt

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화요일, 4월 2, 2024
Ulcerative colitis, Psoriasis, Rheumatoid arthritis, Growth, Ankylosing spondylitis, Drug, EDA, Ageing, Kingdom Holding Company, Crohn's disease, Lung cancer, GMP, Bevacizumab, Infliximab, Pharmaceutical industry

In 2022, Kexing Biopharm secured agreements with 24 overseas market customers and commenced the submission of local drug access registration documents.

Key Points: 
  • In 2022, Kexing Biopharm secured agreements with 24 overseas market customers and commenced the submission of local drug access registration documents.
  • The product underwent GMP audits in Egypt, Brazil, and Indonesia respectively in September 2023, February 2024, and March 2024.
  • In 2022, Kexing Biopharm swiftly reached agreements with 23 overseas market customers, initiating the submission of drug access registration documents.
  • By establishing local subsidiaries, Kexing Biopharm strives to accelerate product registration processes and enhance competitiveness in overseas markets.

Completion of PIC/S Participating Authorities' Audits of Kexing Biopharm's Licensed Product Infliximab for Injection

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화요일, 4월 2, 2024
Certification, Brazilian Health Regulatory Agency, News, EPO, ANVISA, GMP, PIC/S, Infliximab, Food

New York, New York--(Newsfile Corp. - April 2, 2024) - The product infliximab for injection, licensed by Kexing Biopharm, has recently experienced a wave of encouraging news regarding its international commercialization.

Key Points: 
  • New York, New York--(Newsfile Corp. - April 2, 2024) - The product infliximab for injection, licensed by Kexing Biopharm, has recently experienced a wave of encouraging news regarding its international commercialization.
  • In addition, this month, the product has undergone a site GMP audit by another PIC/S Participating Authority, the Indonesian Food and Drug Authority (BPOM).
  • The company's proprietary product, human erythropoietin (EPO), has been present in Indonesia since 2005, gaining popularity and increasing market share.
  • In terms of infliximab, progress has been remarkable in the overseas factory inspection since the third quarter of 2023.

Gastroenterologists Slow to Adopt Eli Lilly’s Omvoh, Pfizer’s Velsipity, and Takeda’s subcutaneous formulation of Entyvio for the Treatment of Ulcerative Colitis, but Future Projections Reveal a Highly Evolving Market

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금요일, 3월 22, 2024
Launch, Ulcerative colitis, Benchmarking, Patient, Gastroenterology, RealTime, Inflammatory bowel disease, FDA, Infliximab, Pharmaceutical industry

The latest results reveal gastroenterologists (n=73) have been slow to incorporate the newest entrants into their already bustling armamentarium, though project rapid adoption over the course of 2024.

Key Points: 
  • The latest results reveal gastroenterologists (n=73) have been slow to incorporate the newest entrants into their already bustling armamentarium, though project rapid adoption over the course of 2024.
  • In terms of unaided awareness of the newly approved medications, Omvoh had the highest recall rates, followed closely by Velsipity and more distantly by Entyvio SC.
  • Conversely, but as expected, Entyvio SC is the most familiar among the three, followed by Velsipity and then Omvoh.
  • The adoption trends regarding gastroenterologist trial rates, overall market share, and average patient initiations exhibit a consistent pattern.

Advanced Infliximab Model Now Available from DoseMe

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금요일, 3월 15, 2024
Technology, Research, Health Technology, Software, Biotechnology, Health, Pharmaceutical, Data Management, Science, Inflammatory bowel disease, Risk, Infliximab, IBD, Patient, Immunoglobulin G, BCPS, Doctor of Pharmacy, Inflammation, Vaccine

DoseMe , a leading provider of model-informed precision dosing, today announced the availability of its Infliximab model.

Key Points: 
  • DoseMe , a leading provider of model-informed precision dosing, today announced the availability of its Infliximab model.
  • Infliximab (IFX) is a purified, recombinant DNA-derived chimeric IgG monoclonal antibody protein that contains both murine and human components that inhibit tumor necrosis factor-alpha(TNFα).
  • "We continue to enhance our models, and this model may predict infliximab concentration in patients with anti-drug antibodies,” added Roy.
  • “Both the learning set and validation set of this model had a large diversity in an indication of the patients, thus making this model especially equipped to dose infliximab for many indications.”
    For more information and an overview of all models currently available, visit https://doseme-rx.com/why-dosemerx/drug-packages

Citryll Announces the Appointment of Maarten Kraan as Chief Medical Officer

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화요일, 2월 13, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Clinical Trials, Other Health, MSD, Therapy, Roche, Infliximab, Pfizer, AstraZeneca, Senior, Immune-mediated inflammatory diseases, Merck, Schering-Plough, CMO, Neutrophil, Research and development, Adalimumab, Inflammation, Belatacept, Leiden University, Stallergenes Greer, Bristol Myers Squibb, Abatacept, Rheumatoid arthritis, Hidradenitis suppurativa, Merck & Co., Patient, Pierre Fabre, Biology, Development, Pharmaceutical industry

Citryll, a clinical-stage biotech company developing first-in-class therapeutics to treat immune-mediated inflammatory diseases, today announced the appointment of Maarten Kraan, M.D., Ph.D., as Chief Medical Officer.

Key Points: 
  • Citryll, a clinical-stage biotech company developing first-in-class therapeutics to treat immune-mediated inflammatory diseases, today announced the appointment of Maarten Kraan, M.D., Ph.D., as Chief Medical Officer.
  • Prior to that, he held various senior medical and R&D positions at Pierre Fabre S.A., AstraZeneca, Roche and Bristol Myers-Squibb.
  • Dr. Kraan will replace Dr. Patrick Round, who will continue to support the company during the transition period.
  • Notably, Dr. Kraan was also involved in the development of Orencia (abatacept), Remicade (infliximab), Humira (adalimumab) and fostamatinib for rheumatoid arthritis.

Johnson & Johnson Reports Q4 and Full-Year 2023 Results

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화요일, 1월 23, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Growth, Contact, Ustekinumab, Esketamine, General surgery, Infliximab, Abiraterone acetate, Press release, Acquisition, COVID-19, Medtech, Johnson & Johnson, Abiomed, Daratumumab, Security (finance), News, Pharmaceutical industry

Adjusted operational sales* reflected below excludes the net impact of acquisitions and divestitures and translational currency.

Key Points: 
  • Adjusted operational sales* reflected below excludes the net impact of acquisitions and divestitures and translational currency.
  • Innovative Medicine worldwide operational sales, excluding the COVID-19 Vaccine, grew 7.2%*.
  • Notable New Announcements in the Quarter:
    The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K.
  • Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson.

Celltrion presents strategic vision and growth plan at the 42nd Annual J.P. Morgan Healthcare Conference

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목요일, 1월 11, 2024
Celltrion, Patient, Health, Intelligence, Biosimilar, PHS, Infliximab, Conference, Drug development, FDA, Pharmaceutical industry

Celltrion's Chairman Jung-Jin Seo and CEO Jin-Seok Seo discussed the company's strategic priorities and progress, including the company's vision to move beyond biosimilars through the 2024 launch of ZYMFENTRA™ in the U.S. and expansion into digital healthcare.

Key Points: 
  • Celltrion's Chairman Jung-Jin Seo and CEO Jin-Seok Seo discussed the company's strategic priorities and progress, including the company's vision to move beyond biosimilars through the 2024 launch of ZYMFENTRA™ in the U.S. and expansion into digital healthcare.
  • He also shared insights and trends on the biosimilar industry and how the market landscape is impacting Celltrion's strategy.
  • Jin-Seok Seo said, ''Celltrion has the potential to grow its revenue by at least fivefold in 2030, once our 22-drug portfolio is commercialized.
  • Celltrion remains committed to pursuing its goal in promoting the health and well-being of patients."

US Gastroenterologist Projections Suggest Significant Shift in Ulcerative Colitis Landscape Afoot, with Launches of Eli Lilly's Omvoh, Pfizer's Velsipity, Takeda's Subcutaneous Entyvio, and Celltrion's Zymfentra

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월요일, 11월 13, 2023
HCP, Ustekinumab, Pfizer, Q3, JAK, Takeda, Patient, MOA, AbbVie, Colitis, Ulcerative colitis, Benchmarking, IBD, Launch, Upadacitinib, BMS, S1P, Infliximab, Adalimumab, Gastroenterology, Celltrion, UC, RealTime, Pharmaceutical industry, Tofacitinib, Vedolizumab, Lilly

These additions come amidst an already bustling market, teeming with both branded and increasingly competitive biosimilar alternatives.

Key Points: 
  • These additions come amidst an already bustling market, teeming with both branded and increasingly competitive biosimilar alternatives.
  • However, the influx of innovative agents suggests that upcoming changes are poised to be more substantial and transformative.
  • This extension enjoys the highest pre-launch familiarity and generates significantly higher interest in gaining approval.
  • Although prescribers display significant enthusiasm for Entyvio SC, its anticipated impact on the broader market is projected to be modest.