Top 5 Approved Subcutaneous Biologics
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Published: January 2025
Owing to the increased prevalence of chronic disorders and heightened emphasis towards patient compliance, the pharmaceutical industry is increasingly shifting focus towards the development of subcutaneous biologics. We analyzed over 175 subcutaneous biologics that are approved for the treatment of various chronic disorders. In this article, discover top 5 approved subcutaneous biologics along with the information on associated drug developers engaged in the industry.
Over the years, there has been a significant rise in the preference for subcutaneous biologics by patients as well as healthcare professionals. This can be attributed to the limitations associated with other routes of administration, such as low bioavailability and variable absorption rates. However, despite the increasing preference for subcutaneous biologics, pharmaceutical companies are facing several challenges to develop biologics with high dose concentration due to their inherent nature of forming protein aggregates. This also leads to increased viscosity of the solution, which can induce undesirable immunogenic responses and can compromise the efficacy and safety of the drug. To address these challenges, various technology platforms are being developed to enable the formulation of subcutaneous biologics with high concentration and viscosity.
Further, subcutaneous drug delivery devices such as, large volume wearable injectors, autoinjectors, needle-free injection system, novel drug reconstitution system and prefilled syringes have garnered significant attention within the pharmaceutical industry. This interest stems from their efficient and patient-friendly approach to administering medications. The subcutaneous drug delivery industry is rapidly evolving, with a focus on developing more convenient systems designed to enhance medication adherence. Moreover, as the availability of subcutaneous biologics increases, the demand for innovative delivery devices within the subcutaneous biologics market is also expected to rise. Consequently, it has been observed that many pharma companies are directing their efforts towards introducing subcutaneous versions of their drugs by re-engineering and reformulating products that were initially developed for delivery via the intravenous route.
Roots Analysis has conducted an exhaustive study on Subcutaneous Biologics Market featuring the current approved and clinical-stage subcutaneous biologics landscape, subcutaneous formulation technology landscape, drug delivery systems market landscape and future opportunity for the drug as well as technology developers that are engaged in the subcutaneous biologics industry, over a span of 11 years.
Table of Contents
The top five approved subcutaneous biologics along with the information on their developers, initial approval year and type of biologic are listed below (in alphabetical order of drug name):
Table 1: List of Top 5 Approved Subcutaneous Biologics
| S. No. | Drug Name | Developer Name | Initial Approval Year | Type of Biologic |
| 1 | Cosentyx | Novartis | 2015 | Antibody |
| 2 | Enbrel Subcutaneous | Amgen | 1998 | Protein |
| 3 | Humira Subcutaneous | AbbVie | 2002 | Antibody |
| 4 | Orencia Subcutaneous | Bristol-Myers Squibb | 2011 | Protein |
| 5 | Tremfya | Johnson & Johnson | 2017 | Antibody |
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Discover Below the Details on Top Five Approved Subcutaneous Biologics
This article highlights the top 5 approved subcutaneous biologics to watch out for in this industry. It is essential to note that the selection of top players can differ substantially according to the defined criteria.
With ~75% Reduction in the Symptoms, Cosentyx Claims to be the Forefront Therapy for Psoriasis
1. Cosentyx®
Cosentyx, generically known as secukinumab, is a monoclonal antibody that was first approved in 2015. The drug works by inhibiting interleukin-17A (IL-17A), which helps in reducing inflammation associated with the various autoimmune and inflammatory disorders. Interestingly, it is administered in several forms via subcutaneous injections including an UnoReady pen, sensoready pen and a prefilled syringe.
For full year 2023, the drug brought in revenues of USD 4.98 billion, majority of which was contributed by the subcutaneous formulation. IV formulation of Cosentyx received approval from the US FDA in October 2023.
Developer’s Details
The details on the year of establishment, number of employees and headquarters of Novartis have been listed below:
Novartis: Company Details
| Key Parameters | Description |
| Company Logo |  |
| Year of Establisment | 1996 |
| Number of Employees | 10,001+ |
| Headquarters |  |
Development Related to Other Subcutaneous Biologics from Novartis:
In August 2024, the company entered into a technology licensing agreement with Lindy Biosciences in order to develop self-administered subcutaneous injections for the drugs in Novartis’ portfolio. Earlier, in February 2024, the United States Food and Drug Administration (USFDA) approved Novartis’ Xolair®, another subcutaneous antibody therapy from Novartis that is FDA-approved to reduce allergic reactions in people with one or more food allergies. In the coming years, the firm is expected to continue focusing on research and development efforts, in order to further strengthen its pipeline of drug / therapy candidates.
To know more about Cosentyx and other approved subcutaneous biologics, access our full report.
Enbrel, Generically Known as Etanercept, is a Highly Efficacious Drug Used for the Treatment of Psoriatic Arthritis
2. Enbrel® Subcutaneous
Enbrel subq, a protein-based biologic, is currently approved for the treatment of autoimmune and inflammatory disorders. It works by blocking the tumor necrosis factor (TNF), which is a primary regulator of immune responses in the body. The drug was initially approved in 1998 and can be administered through a prefilled syringe or an autoinjector. Further, Amgen obtained all the rights for development and commercialization of Enbrel subq from Immunex in 2002, post the acquisition of the latter company.
The drug generated revenues of $ 3.697 billion during FY 2023.
Developer’s Details
The details on the year of establishment, number of employees and headquarters of Amgen have been listed below:
Amgen: Company Details
| Key Parameters | Description |
| Company Logo |  |
| Year of Establisment | 1980 |
| Number of Employees | 10,001+ |
| Headquarters |  |
Development Related to Other Subcutaneous Biologics from Amgen:
In November 2024, Amgen reported that MariTide, an investigational antibody peptide conjugate administered subcutaneously exhibited approximately 20% loss of weight in patients suffering with obesity without type 2 diabetes. Interestingly, the company currently has over ten approved subcutaneous biologics in its drug portfolio, including AIMOVIG® and TEZSPIRE®, which have been developed in collaboration with Novartis and AstraZeneca, respectively. Amgen is also focused on evaluating its approved subcutaneous biologics for other indications including rare and oncological disorders.
To know more about Enbrel Subq and other approved subcutaneous biologics, access our full report.
Humira, a Subcutaneous Biologic Registered in the World Health Organization’s List of Essential Medicines
3. Humira® Subcutaneous
Humira, an antibody-based biologic, is currently being used for the treatment of various autoimmune and inflammatory disorders including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, Crohn’s disease, plaque psoriasis, ulcerative colitis, uveitis and hidradenitis suppurativa. The drug can be administered once weekly or bi-weekly through a prefilled syringe or as a humira pen subcutaneous. Further, it was initially approved for medical use in 2002, and it remained exclusively in the market for approximately 20 years, until its patent expired in 2023.
Soon after the patent expiry a number of biosimilars entered the market and eroded Humira sales. For FY 2023, AbbVie reported revenues of $ 14.4 billion, a decline of 31.9% over the previous year and for 9M 2024 the drug has generated sales of $ 7.3 billion.
Developer’s Details
The details on the year of establishment, number of employees and headquarters of AbbVie have been listed below:
AbbVie: Company Details
| Key Parameters | Description |
| Company Logo |  |
| Year of Establisment | 2013 |
| Number of Employees | 10,001+ |
| Headquarters |  |
Development Related to Other Subcutaneous Biologics from AbbVie:
In June 2024, the USFDA granted accelerated approval to EPKINLY®, a bispecific antibody used for the treatment of patients suffering from relapsed / refractory follicular lymphoma. Interestingly, this drug is being developed collaboratively by Genmab and AbbVie and the companies aim to explore the potential of this drug for many monotherapy and combination therapy treatments targeting hematological cancers.
To know more about Humira Subcutaneous and other approved subcutaneous biologics, access our full report.
Orencia, the First and Only USFDA-approved for the Prevention of Acute Graft Versus Host Disease (aGvHD)
4. Orencia® Subcutaneous
Orencia subq is a selective T-cell stimulation modulator, currently approved for once weekly administration to reduce inflammatory symptoms such as swelling, pain and stiffness. The drug was initially approved in 2011, and its patent expired in 2017 and 2019, in the US and Europe, respectively. Interestingly, in December 2019, it was granted with the USFDA breakthrough therapy designation for prevention of Acute Graft Versus Host Disease (aGvHD).
Orencia was originally approved as IV formulation in 2005. Orencia subq received FDA approval in 2011 for treatment of moderate to severe rheumatoid arthritis in adults. For FY 2023, the drug generated revenues of $ 3.6 billion.
Developer’s Details
The details on the year of establishment, number of employees and headquarters of Bristol-Myers Squibb have been listed below:
Bristol-Myers Squibb: Company Details
| Key Parameters | Description |
| Company Logo |  |
| Year of Establisment | 1858 |
| Number of Employees | 10,001+ |
| Headquarters |  |
Development Related to Other Subcutaneous Biologics from Bristol Myers Squibb:
In May 2024, the USFDA accepted Biologics License Application (BLA) for OPDIVO®, which is co-formulated with Halozyme’s proprietary recombinant human hyaluronidase. Further, in June 2024, based on the results of CheckMate -67T phase 3 trials, the European Medicines Agency validated the application submitted for OPDIVO®. The application has been submitted to get approval for subcutaneous nivolumab formulation to treat multiple adult solid tumor indications in the European Union.
To know more about Orencia Subq and other approved subcutaneous biologics, access our full report.
Tremfya, a Blockbuster Drug for Psoriasis and Ulcerative Colitis, Recently Approved for Inflammatory Bowel Disease
5. Tremfya®
Tremfya is a monoclonal antibody used primarily for the treatment of autoimmune disorders including plaque psoriasis and psoriatic arthritis. Further, the drug is currently approved for once monthly or bi-monthly administration depending on the severity of condition. Moreover, it is important to note that Tremfya was the first biologic approved for the treatment of active psoriatic arthritis.
Tremfya received USFDA approval for the treatment of plaque psoriasis and active psoriatic arthritis in the years 2017 and 2020, respectively. Moreover, in September 2024, the subcutaneous formulation of this drug received USFDA approval for the treatment of ulcerative colitis. For FY 2023, the drug generated revenues worth USD 3.1 billion, indicating an increase of 18% compared to FY 2022.
Developer’s Details
The details on the year of establishment, number of employees and headquarters of Johnson & Johnson have been listed below:
Johnson & Johnson: Company Details
| Key Parameters | Description |
| Company Logo |  |
| Year of Establisment | 1886 |
| Number of Employees | 10,001+ |
| Headquarters |  |
Development Related to Other Subcutaneous Biologics from Johnson & Johnson:
In December 2024, the USFDA denied the approval for subcutaneous formulation of RYBREVANT®, a monoclonal antibody used for the treatment of non-small cell lung cancer. Notably, the reason for rejection was primarily the concerns related to manufacturing facility, which were identified during the pre-inspection. The company aims to resolve these issues as soon as possible. Further, in October 2024, the company filed for FDA approval of DARZALEX FASPRO® as a potential standard of care in newly diagnosed patients regardless of transplant eligibility. This indication, if approved, will be the first treatment regimen for newly diagnosed multiple myeloma based on a study with MRD-negativity as the primary endpoint.
To know more about Tremfya and other approved subcutaneous biologics, access our full report.
What About the Other Approved Subcutaneous Biologics?
The above presentation features top five approved subcutaneous biologics from a pool of over 175 drugs that we have compiled. If you're interested, you can download the Sample Report on this topic by Roots Analysis. For personalized assistance in identifying the most relevant solutions based on your specific criteria, please don't hesitate to reach out to us at sales@rootsanalysis.com.
Sources
- https://www.novartis.com/investors/financial-data/product-sales
- https://www.novartis.com/us-en/news/media-releases/fda-approves-novartis-cosentyx-first-intravenous-iv-formulation-interleukin-17a-antagonist-rheumatic-diseases
- https://investors.amgen.com/news-releases/news-release-details/amgen-announces-robust-weight-loss-maritide-people-living
- https://www.amgenpipeline.com/-/media/Themes/Amgen/amgenpipeline-com/amgenpipeline-com/PDF/amgen-pipeline-chart.pdf
- https://investors.abbvie.com/news-releases/news-release-details/abbvie-reports-full-year-and-fourth-quarter-2023-financial
- https://www.cancerresearch.org/blog/june-2024/fda-approves-epkinly-for-relapsed-or-refractory-follicular-lymphoma
- https://news.bms.com/news/details/2024/Bristol-Myers-Squibb-Reports-Fourth-Quarter-and-Full-Year-Financial-Results-for-2023/default.aspx
- https://finance.yahoo.com/news/european-medicines-agency-validates-bristol-105900006.html
- https://www.biospace.com/fda/j-js-fda-bid-for-subcutaneous-rybrevant-falls-short
- https://www.jnj.com/media-center/press-releases/johnson-johnson-files-for-u-s-fda-approval-of-darzalex-faspro-based-quadruplet-regimen-for-newly-diagnosed-multiple-myeloma-patients-for-whom-transplant-is-not-planned