1. Market Research
  2. > Pharmaceutical Market Trends
Humira Biosimilars Clinical Trial Insight

Humira Biosimilars Clinical Trial Insight

  • October 2016
  • 80 pages
  • ID: 4397345
  • Format: PDF
  • PNS Pharma


Table of Contents

“Humira Biosimilars Clinical Trial Insight” report by PNS Pharma gives comprehensive clinical insight on 33 biosimilars version of Humira drug in clinical pipeline. More than 10 of these biosimilars are in Phase-III trials and are expected to be commercially available in next 5-8 years. The patent protection assigned to Humira will expire in 2016 for US and 2018 for European market.

The Humira stands for Human Monoclonal Antibody in Rheumatoid Arthritis. It is also termed as Adalimumab or D2E7 and is a recombinant Immunoglobulin G1 monoclonal antibody which is specific for tumor necrosis factor alpha (TNF-?). It is a drug designed by the mode of recombinant DNA technology for the treatment of rheumatoid arthritis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. In the rheumatoid arthritis adalimumab has the equivalent efficacy as that of methotrexate.
The chemical and biological components of Humira define it as a TNF inhibiting anti-inflammatory biologic medication. It binds to the TNF-? which leads to the inflammatory response of autoimmune diseases but after the conjugation of Humira it reduces the inflammatory response.

The mechanism of action includes the binding of HUMIRA specifically to TNF-? and renders it, incapable of binding to its receptors on cell surfaces. TNF-? exerts its pro-inflammatory role by binding to its cell surface receptor. When HUMIRA binds to the membrane bound version of TNF-? on TNF-?-producing cells, it can lead to lysis of these TNF-? producing cell in the presence of complement.

TNF- ? level is found elevated in the synovial fluids of rheumatoid arthritis. TNF-? is one of the important factors that contribute to the pathology and perpetuation of the inflamed and destroyed joints in rheumatoid arthritis. Given that rheumatoid arthritis is a complex disease with multiple factors involved, the ability for a monoclonal antibody to neutralize the function of one single cytokine TNF-? and greatly improve the symptoms and progression of rheumatoid arthritis.

It is produced by Abbot Laboratories but originally Humira was emerged from collaboration between Bioresearch Center in Massachusetts (BASF) and the Cambridge Antibody Technologies in the UK.Mid stage clinical trials were so promising that, at the end of 2000, Abbott agreed to buy the BASF Bioresearch Center for US$ 6.9 Billion.When Humira was launched in 2003, it was the third TNF-alpha antibody to the market. Its US, FDA approval for marketing was achieved on December 31, 2002. In 2012 to 2015 Humira topped the top selling pharmaceutical product lists and in 2015, Humira had topped US$ 14 Billion of sales globally.

However, its superior dosing schedule and improved toleration over existing therapy enabled it to become the best in class agent.Furthermore, Abbott had a robust development program for Humira and expanded its use to other inflammatory disease such as psoriasis, Crohn’s disease, and juvenile idiopathic arthritis.While prescribed to far fewer patients than Lipitor, the high cost of this biological medicine is such that Humira’s sales were projected to exceed US$ 9 Billion.
In December 2014, Indian drug maker Cadila Healthcare declared the launch of the first adalimumab biosimilar at a fifth of its U.S. price. The generic has been launched under the brand name Exemptia. In January 2016, another Indian drug maker Torrent Pharmaceuticals launched its biosimilar for adalimumab. Torrent's Adfrar would be the second generic biosimilar of adalimumab in the world. In September 2016 the US FDA approved Amgens biosimilar adalimumab-atto sold under the brand name Amjevita.

Get Industry Insights. Simply.

  • Latest reports & slideshows with insights from top research analysts
  • 150+ Million searchable statistics with tables, figures & datasets
  • More than 25,000 trusted sources
  • Single User License — provides access to the report by one individual.
  • Department License — allows you to share the report with up to 5 users
  • Site License — allows the report to be shared amongst all employees in a defined country
  • Corporate License — allows for complete access, globally.

ReportLinker may already be registered as a supplier with your company. If you want to Order by PO, check with us first and we'll let you know if we are a registered supplier and what the vendor number is. Otherwise, we'll provide you with the necessary information to register ReportLinker as a vendor.

Grace helps you find the right report:

The research specialist advised us on the best content for our needs and provided a great report and follow-up, thanks very much we shall look at ReportLinker in the future.

Kate Merrick

Global Marketing Manager at
Eurotherm by Schneider Electric

We were impressed with the support that ReportLinker’s research specialists’ team provided. The report we purchased was useful and provided exactly what we want.

Category Manager at

ReportLinker gave access to reliable and useful data while avoiding dispersing resources and spending too much time on unnecessary research.

Executive Director at
PwC Advisory

The customer service was fast, responsive, and 100% professional in all my dealings (...) If we have more research needs, I'll certainly prioritize working with ReportLinker!

Scott Griffith

Vice President Marketing at
Maurice Sporting Goods

The research specialist provided prompt, helpful instructions for accessing ReportLinker's product. He also followed up to make sure everything went smoothly and to ensure an easy transition to the next stage of my research

Jessica P Huffman

Research Associate at
American Transportation Research Institute

Excellent customer service. Very responsive and fast.

Director, Corporate Strategy at

I reached out to ReportLinker for a detailed market study on the Air Treatment industry. The quality of the report, the research specialist’s willingness to solve my queries exceeded my expectations. I would definitely recommend ReportLinker for in-depth industry information.

Mariana Mendoza

Global Platform Senior Manager at
Whirlpool Corporation

Thanks! I like what you've provided and will certainly come back if I need to do further research works.

Bee Hin Png

CEO at
LDR Pte Ltd

The research specialist advised us on the best content for our needs and provided a great report and follow-up, thanks very much we shall look at ReportLinker in the future.

Kate Merrick

Global Marketing Manager at
Eurotherm by Schneider Electric

  • How we can help
    • I am not sure if the report I am interested in will fulfill my needs. Can you help me?
    • Yes, of course. You can call us at +33(0) 4 37 65 17 03 or drop us an email at [email protected] to let us know more about your requirements.
    • We buy reports often - can ReportLinker get me any benefits?
    • Yes. Set up a call with a Senior Research Advisor to learn more - [email protected] or +33(0) 4 37 65 17 03.
    • I have had negative experiences with market research reports before. How can you avoid this from happening again?
    • We advise all clients to read the TOC and Summary and list your questions so that we can get more insight for you before you make any purchase decision. A research advisor will accompany you so that you can compare samples and reports from different sources, and choose the study that is right for you.

  • Report Delivery
    • How and when I will receive my Report?
    • Most reports are delivered right away in a pdf format, while others are accessed via a secure link and access codes. Do note that sometimes reports are sent within a 12 hour period, depending on the time zones. However, you can contact us to escalate this. Should you need a hard copy, you can check if this option is offered for the particular report, and pay the related fees.
  • Payment conditions
    • What payment methods do you accept?
      1. Credit card : VISA, American Express, Mastercard, or
      2. You can download an invoice to pay by wire transfer, check, or via a Purchase Order from your company, or
      3. You can pay via a Check made out in US Dollars, Euros, or British Pounds for the full amount made payable to ReportLinker
    • What are ReportLinker’s Payment Terms?
    • All payments must normally be submitted within 30 days. However, you can let us know if you need extended time.
    • Are Taxes and duties included?
    • All companies based in France must pay a 20% tax per report. The same applies to all individuals based in the EU. All EU companies must supply their VAT number when purchasing to avoid this charge.
    • I’m not satisfied. Can I be refunded?
    • No. Once your order has been processed and the publisher has received a notification to send you the report, we cannot issue any refund or cancel any order. As these are not ‘traditional’ products that can be returned, reports that are dispatched are considered to be ‘consumed’.
  • User license
    • The license that you should acquire depends on the number of persons that need to access the report. This can range from Single User (only one person will have the right to read or access the report), or Department License (up to 5 persons), to Site License (a group of persons based in the same company location), or Corporate License (the entire company personnel based worldwide). However, as publishers have different terms and conditions, we can look into this for you.
Purchase Reports From Reputable Market Research Publishers

Uveitis Drugs in Development by Stages, Target, MoA, RoA, Molecule Type and Key Players, 2022 Update

  • $ 2000
  • June 2022
  • 176 pages

Uveitis Drugs in Development by Stages, Target, MoA, RoA, Molecule Type and Key Players, 2022 Update Summary This latest Pharmaceutical and Healthcare disease pipeline guide Uveitis – Drugs In Development, ...

  • World
  • Pharmaceutical
  • Therapy
  • Industry analysis
  • Drug Approval
  • Stem Cell Transplantation


Reportlinker.com © Copyright 2022. All rights reserved.

ReportLinker simplifies how Analysts and Decision Makers get industry data for their business.

Make sure you don’t miss any news and follow us on