Golimumab

Alvotech Initiates Confirmatory Patient Study for AVT05, a Proposed Biosimilar for Simponi® and Simponi Aria®

Retrieved on: 
Thursday, May 4, 2023
Trial of the century, Rheumatoid arthritis, Pleasure, Johnson & Johnson, EU, Patient, Safety, Pharmaceutical industry, Golimumab

REYKJAVIK, Iceland, May 04, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation of Alvotech’s confirmatory patient study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab).

Key Points: 
  • REYKJAVIK, Iceland, May 04, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation of Alvotech’s confirmatory patient study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab).
  • The objective of the clinical study is to compare the efficacy, safety, and immunogenicity of AVT05 and Simponi® in adult patients with moderate to severe rheumatoid arthritis.
  • “It is a pleasure to be able to mark another clinical milestone in our biosimilars development pipeline,” said Joseph McClellan, Chief Scientific Officer.
  • In January 2023 Alvotech announced the initiation of a pharmacokinetic study for AVT05.

Bio-Thera Solutions Initiates Phase III Clinical Trial for BAT2506, a Proposed Biosimilar of Simponi® (Golimumab)

Retrieved on: 
Tuesday, June 8, 2021
Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Drugs, Life sciences, Health care, Biotechnology, TNF inhibitors, Specialty drugs, Biosimilar, Monoclonal antibodies, Bevacizumab, Golimumab, Santorini

Bio-Thera Solutions, Ltd. (688177.SH), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase III clinical study for BAT2506, a proposed biosimilar of Simponi (golimumab).

Key Points: 
  • Bio-Thera Solutions, Ltd. (688177.SH), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase III clinical study for BAT2506, a proposed biosimilar of Simponi (golimumab).
  • Patient enrollment in our Phase III clinical trial for BAT2506 is another important achievement for Bio-Thera as it is our third proposed biosimilar to enter a global Phase 3 study, said Shengfeng Li, CEO, Bio-Thera Solutions.
  • Bio-Thera Solutions is developing several additional proposed biosimilars, including a bevacizumab biosimilar and a tocilizumab biosimilar that have both successfully completed global Phase III clinical trials.
  • 2 QLETLI is a registered trademark of Bio-Thera Solutions, Ltd.
    3 is a registered trademark of Bio-Thera Solutions, Ltd.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210608005454/en/

Global TNF Alpha Inhibitors Markets 2020-2030: Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), & Simponi (golimumab)

Retrieved on: 
Tuesday, March 30, 2021
Drugs, Medical specialties, Monoclonal antibodies, TNF inhibitors, Immunosuppressants, Biotechnology, Janssen Biotech, Infliximab, Etanercept, Golimumab, Adalimumab, Certolizumab pegol

The TNF alpha inhibitors market consists of sales of tumor necrosis factor-alpha (TNF-) inhibitors by entities that manufacture TNF alpha inhibitors.

Key Points: 
  • The TNF alpha inhibitors market consists of sales of tumor necrosis factor-alpha (TNF-) inhibitors by entities that manufacture TNF alpha inhibitors.
  • The TNF alpha inhibitors market covered in this report is segmented by drug into remicade (infliximab); enbrel (etanercept); humira (adalimumab); cimzia (certolizumab pegol); simponi (golimumab).
  • The adverse side effects of TNF alpha inhibitors on patients are expected to limit the growth of the TNF alpha inhibitors market.
  • Global TNF Alpha Inhibitors Market, Segmentation By Drug, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

Cipla Gulf Expands Partnership with Alvotech for Commercialization of Biosimilars in Australia and New Zealand

Retrieved on: 
Tuesday, March 2, 2021
Drugs, Monoclonal antibodies, TNF inhibitors, Cipla, NIFTY 50, Immunosuppressants, Biotechnology, Biosimilar, Adalimumab, Golimumab, Aflibercept, Denosumab, Drugs, Monoclonal antibodies, TNF inhibitors, Cipla, NIFTY 50, Immunosuppressants, Biotechnology, Biosimilar, Adalimumab, Golimumab, Aflibercept, Denosumab

MUMBAI, India, March 2, 2021 /PRNewswire/ -- Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) referred to as "Cipla" today announced that its subsidiary, Cipla Gulf FZ LCC ("Cipla Gulf') is expanding its partnership with Alvotech for the marketing and distribution of four biosimilar medicines in Australia and New Zealand.

Key Points: 
  • MUMBAI, India, March 2, 2021 /PRNewswire/ -- Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) referred to as "Cipla" today announced that its subsidiary, Cipla Gulf FZ LCC ("Cipla Gulf') is expanding its partnership with Alvotech for the marketing and distribution of four biosimilar medicines in Australia and New Zealand.
  • As part of this strategic alliance, Cipla Gulf will be responsible for commercialization of patented biosimilars of the biologic medicine brands,Aflibercept (Eylea), Ustekimumab (Stelara), Denosumab (Prolia, Xgeva) and Golimumab (Simponi).
  • The products are developed and manufactured by Alvotech and will be distributed by Cipla Gulf through Australia and New Zealand distribution networks.
  • Cipla Gulf had previously entered into a similar agreement with Alvotech in July 2019 for the commercialization of AVT02, an adalimumab biosimilar, in select emerging markets.

Bio-Thera Solutions Submits Marketing Authorization Application (MAA) for BAT1706, a Proposed Biosimilar to Avastin®, to European Medicines Agency (EMA)

Retrieved on: 
Wednesday, November 25, 2020
Biotechnology, Technology, Health, General Health, Pharmaceutical, Oncology, Other Science, Other Technology, Research, Science, Clinical trials, Drugs, Monoclonal antibodies, Immunosuppressants, TNF inhibitors, Janssen Biotech, Biotechnology, Biosimilar, Adalimumab, Bevacizumab, Ustekinumab, Golimumab, BAT1706, Bio-Thera Solutions

Bio-Thera seeks a commercial license for all approved indications of bevacizumab in the European Union (EU) Member States, Iceland, Norway and Liechtenstein.

Key Points: 
  • Bio-Thera seeks a commercial license for all approved indications of bevacizumab in the European Union (EU) Member States, Iceland, Norway and Liechtenstein.
  • BAT1706 is a proposed bevacizumab biosimilar developed by the company.
  • The companys first biosimilar product, QLETLI (), a biosimilar to Humira (adalimumab), has received marketing authorization and is available in China.
  • Bio-Thera Solutions is developing several additional proposed biosimilars, including golimumab, ustekinumab and secukinumab, and mepolizumab among others.

SIMPONI ARIA® (golimumab) Approved by the U.S. Food and Drug Administration for Active Polyarticular Juvenile Idiopathic Arthritis and Extension of Its Active Psoriatic Arthritis Indication in Patients 2 Years of Age and Older

Retrieved on: 
Wednesday, September 30, 2020
Drugs, Health, Monoclonal antibodies, Janssen Biotech, TNF inhibitors, Golimumab, Pharmaceutical industry, Clinical trial

Trial results demonstrated that pharmacokinetic (PK) exposure of SIMPONI ARIA was consistent with that of two pivotal Phase 3 clinical trials of SIMPONI ARIA in adult patients with moderately to severely active RA and active PsA.

Key Points: 
  • Trial results demonstrated that pharmacokinetic (PK) exposure of SIMPONI ARIA was consistent with that of two pivotal Phase 3 clinical trials of SIMPONI ARIA in adult patients with moderately to severely active RA and active PsA.
  • The adverse reactions observed in GO-VIVA were consistent with the established safety profile of SIMPONI ARIA in adult patients with RA and PsA.
  • Janssen CarePath offers a comprehensive support program that helps patients get started on SIMPONI ARIA and stay on track.
  • Your doctor will test you for TB before starting SIMPONI ARIA and will closely monitor you for signs of TB during treatment.

Bio-Thera Solutions Partners with Pharmapark to Market BAT2506 in Russia and other CIS Countries

Retrieved on: 
Friday, July 17, 2020
Technology, Research, Other Technology, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, TNF inhibitors, Janssen Biotech, Life sciences, Articles, Post-Soviet states, Golimumab, Johnson & Johnson, Commonwealth of Independent States, Biosimilar, Natural sciences

The Phase III global clinical study will include patients from China, Russia and many other countries.

Key Points: 
  • The Phase III global clinical study will include patients from China, Russia and many other countries.
  • Pharmapark will be responsible for filing the dossier in Russia and other CIS countries.
  • This partnership will leverage Pharmaparks strong local presence, sales and marketing capabilities in Russia and other CIS countries.
  • Bio-Thera is pleased to partner with Pharmapark to commercialize our golimumab biosimilar program in Russia and other CIS countries, said Dr. Shengfeng Li, CEO of Bio-Thera.

Ankylosing Spondylitis Market Size Worth $7.9 Billion By 2027 | CAGR: 8.3%: Grand View Research, Inc.

Retrieved on: 
Thursday, June 18, 2020
Medical specialties, Medicine, Rheumatology, RTT, Drugs, TNF inhibitors, Johnson & Johnson, Golimumab, Janssen Biotech, Ankylosing spondylitis, Arthritis, Spondylitis

SAN FRANCISCO, June 18, 2020 /PRNewswire/ -- The global ankylosing spondylitis market size is expected to reach USD 7.9 billion by 2027 registering a CAGR of 8.3%, according to a new report by Grand View Research, Inc.

Key Points: 
  • SAN FRANCISCO, June 18, 2020 /PRNewswire/ -- The global ankylosing spondylitis market size is expected to reach USD 7.9 billion by 2027 registering a CAGR of 8.3%, according to a new report by Grand View Research, Inc.
  • Pharmaceutical companies are aiming at label expansion and patent extension for maintaining their share in the market.
  • In October 2017, Johnson & Johnson Services received approval for Simponi Aria for AS treatment for the treatment active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS).
  • Grand View Research has segmented the global ankylosing spondylitis market based on drug and region:
    Ankylosing Spondylitis Drug Outlook (Revenue, USD Million, 2016 - 2027)

Ankylosing Spondylitis Market Size Worth $7.9 Billion By 2027 | CAGR: 8.3%: Grand View Research, Inc.

Retrieved on: 
Thursday, June 18, 2020
Medical specialties, Medicine, Rheumatology, RTT, Drugs, TNF inhibitors, Johnson & Johnson, Golimumab, Janssen Biotech, Ankylosing spondylitis, Arthritis, Spondylitis

SAN FRANCISCO, June 18, 2020 /PRNewswire/ -- The global ankylosing spondylitis market size is expected to reach USD 7.9 billion by 2027 registering a CAGR of 8.3%, according to a new report by Grand View Research, Inc.

Key Points: 
  • SAN FRANCISCO, June 18, 2020 /PRNewswire/ -- The global ankylosing spondylitis market size is expected to reach USD 7.9 billion by 2027 registering a CAGR of 8.3%, according to a new report by Grand View Research, Inc.
  • Pharmaceutical companies are aiming at label expansion and patent extension for maintaining their share in the market.
  • In October 2017, Johnson & Johnson Services received approval for Simponi Aria for AS treatment for the treatment active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS).
  • Grand View Research has segmented the global ankylosing spondylitis market based on drug and region:
    Ankylosing Spondylitis Drug Outlook (Revenue, USD Million, 2016 - 2027)

Janssen Presenting Data From Its Expanding Rheumatology Portfolio At The 2019 Annual Meeting Of The American College Of Rheumatology

Retrieved on: 
Thursday, October 31, 2019
Medical specialties, Drugs, Medicine, Monoclonal antibodies, Janssen Biotech, TNF inhibitors, Immunology, RTT, Golimumab, Infliximab, Guillain–Barré syndrome, Guillain

Rarely, people using TNF blockers, including SIMPONI ARIA, can have nervous system problems such as multiple sclerosis or Guillain-Barr syndrome.

Key Points: 
  • Rarely, people using TNF blockers, including SIMPONI ARIA, can have nervous system problems such as multiple sclerosis or Guillain-Barr syndrome.
  • If this occurs, your body may not make enough blood cells to help fight infections or help stop bleeding.
  • Please read the full Prescribing Information and Medication Guide for SIMPONI ARIAand discuss any questions you have with your doctor.
  • The Janssen Pharmaceutical Companies market REMICADEin Canada, Central and South America, the Middle East, Africa and Asia Pacific.