HUMIRA® (Adalimumab) Biosimilars: Focus on Approved & Launched Biosimilars, Investigational & Research Use Biosimilars, Inactive/Terminated/Withdrawn Biosimilars, Industry/Non-Industry Partnerships

Overview

Adalimumab was the first fully humanized, monoclonal antibody drug to be approved by the US FDA in 2002. The product was subsequently launched in 2003, and initially only indicated for the treatment of rheumatoid arthritis. In the succeeding years since its launch, HUMIRA® gradually approved for the treatment of psoriatic arthritis (2005), ankylosing spondylitis (2006), Crohn’s disease (2007), plaque psoriasis (2008), ulcerative colitis (2012), hidradenitis suppurativa (2015), among a few other indications. Most recently, the drug was approved by the FDA to treat pediatric patients with moderately to severely active ulcerative colitis (2021). Considering the sheer number of indications that it is eligible to treat and being the first of its kind, it did not take long for HUMIRA® to achieve blockbuster status; Abbott Laboratories reported worldwide sales worth USD 1.4 billion for the product in 2005. HUMIRA®’s performance in the market peaked in 2018, reaching USD 19.9 billion in revenues from product sales. However, since the official launch of the first biosimilars in Europe in the same year, the market share of the originator product has been declining, albeit rather slowly.

With a relatively large intellectual property portfolio and an aggressive legal strategy, AbbVie has been very successful in impeding the entry of adalimumab in the global marketplace. The primary patent covering HUMIRA® was set to expire in 2018; however, leveraging its first to market advantage, AbbVie made extensive efforts, dedicating considerable resources to patent novel uses, features, indications and methods of manufacturing, related to the product. Now, the company has marketing exclusivity till 2034. Since many biosimilars of the drug have already been developed (and launched in various well-regulated and poorly regulated regions, with/without having to reaching a settlement with AbbVie), the company recently concluded several ongoing litigations, regarding product launch, enabling certain developers to launch their respective follow-on products by entering into individual licensing agreements. Regarding the launch of biosimilars, experts consider HUMIRA® to be an exception to the norm; there are many other biologics that have lost patent protection and marketing exclusivity in due time, and now have biosimilar versions in the market. However, given the lucrative opportunity associate with this product, its corresponding biosimilar developer landscape is also vast. In future (after 2023), when multiple enemy products enter the market, the adalimumab biosimilars market is anticipated to witness a sharp spike, in terms of revenues from product sales.
Scope of the Report

The “Adalimumab Biosimilars: Focus on Approved & Launched Biosimilars, Investigational & Research Use Biosimilars, Inactive/Terminated/Withdrawn Biosimilars, Industry/Non-Industry Partnerships” report features an extensive study of the current developer landscape and clinical research scenario related to all the follow-on products of the blockbuster biologic drug, HUMIRA®, which are either available or under development. The information in this report has been presented across two deliverables, namely an Excel sheet, featuring an interactive dashboard, and a PowerPoint presentation, summarizing the ongoing activity in this domain, and key insights drawn from the available data.

The report features the following details:

• Detailed review of the adalimumab biosimilars pipeline and affiliated developer landscape, featuring a list of involved innovator companies and their respective therapy candidates. It includes insights based on the current status of biosimilar candidates, and important developer related details (including headquarters, and type of developer).
• An analysis of the various adalimumab biosimilar candidates that have either been approved and/or launched across developed and developing markets, worldwide. The insights presented in this section are based on a number of relevant parameters, such as current status, year of approval/launch, and geographies where the product has been approved/launched.
• An assessment of the adalimumab biosimilars that are under development, featuring details such as current phase of development and geographical locations where clinical/preclinical research is underway. In addition to the molecules that are in the pipeline, the report also features information on research grade products and inactive, terminated and withdrawn product development programs.
• An analysis of the various partnerships related to adalimumab biosimilars, based on parameters, such as year of partnership, type of partnership, and geographical locations of partnering entities. 
• A detailed assessment of the various marketing and distribution agreements inked in relation to HUMIRA® biosimilars, highlighting the key players involved.

Deliverable Outlines

Excel Deliverable

• The deliverable includes an interactive MS Excel dashboard, offering a wholesome perspective of the adalimumab biosimilars pipeline and the partnership activity in this segment of the biopharmaceutical market. The dashboard is divided into seven independent sections (A-G) that include summary charts and figures (along with relevant slicers) corresponding to [A] the overall follow-on products landscape for HUMIRA®, [B] approved and launched therapies, [C] investigational and research products, [D] inactive/terminated/withdrawn biosimilars, [E] companies that have entered into commercialization agreements with biosimilar developers, [F] partnerships inked between companies involved in the development of adalimumab biosimilars and [G] a drop down menu driven visualization section, where importation details of individual biosimilar can be visualized. 
• It also features five data tables, featuring [A] a detailed summary of the unique adalimumab biosimilars that are already approved or under development, [B] information on approved/launched product and the geographies wherein they are authorized to be marketed, [C] details of HUMIRA® biosimilars that are in the pipeline, those that are intended for research use only and inactive/terminated/withdrawn programs, [D] identities of companies that have entered into marketing and distribution partnership with product developers in this domain, and [E] details related to the publicly reported partnership activity between stakeholders in this segment of the biosimilars market. 

PowerPoint Deliverable

• This deliverable features an executive summary of the contemporary adalimumab biosimilars market, featuring details, such as number of products available/under development, their respective current statuses, information on their developers and commercialization partners and a summary of the partnership activity in this domain. 
• It includes key inputs about the reference product, HUMIRA®, featuring an overview of the company (AbbVie), information on financial performance and a summary of the annual sales of this blockbuster product. 
• A contemporary pipeline analysis, including summary charts and figures from the Excel deliverable along with key insights drawn from the available data. 
• An analysis of partnerships related to adalimumab biosimilars, based on a number of parameters, such as year of partnership, type of partnership, and geographical locations of partnering entities. 
• Finally, it includes profiles of companies having approved/launched adalimumab biosimilars. Each profile includes an overview of the company (including details such as year of establishment, headquarters, and number of employees), its recent financial performance (if available), and important inputs (including an over of the product, presentation formats, and indications for which it is approved and dosage information) related to its proprietary biosimilar products