Autoimmune diseases are complex and diverse, affecting millions of people globally with varying degrees of severity and symptoms. There are limited treatment options for autoimmune diseases. However, advances in medical research and treatment options offer hope for better management and improved quality of life for those affected. In this blog, we attempt to provide insights on biologics as a ray of hope for patients with autoimmune disorders.
Biologics as a treatment option for autoimmune diseases
Biologics have brought a paradigm shift in the treatment of autoimmune diseases, offering targeted, effective, and safer alternatives to traditional therapies. They have significantly improved the quality of life for many patients by providing better disease control and reducing symptoms.
Examples of approved biologics used in treating autoimmune diseases
Rheumatoid Arthritis (RA): Humira (adalimumab), Enbrel (etanercept), Remicade (infliximab), Cimzia (certolizumab pegol), Simponi (golimumab), Orencia (abatacept), Rituxan (rituximab), Actemra (tocilizumab), Kevzara (sarilumab), Kineret (anakinra)
Psoriatic Arthritis (PsA) and Plaque Psoriasis: Humira (adalimumab), Enbrel (etanercept), Remicade (infliximab), Cimzia (certolizumab pegol), Simponi (golimumab), Cosentyx (secukinumab), Taltz (ixekizumab), Siliq (brodalumab), Stelara (Ustekinumab), Skyrizi (risankizumab), Tremfya (guselkumab)
Inflammatory Bowel Disease (IBD), Crohn’s Disease, and Ulcerative Colitis:
Humira (adalimumab), Enbrel (etanercept), Remicade (infliximab), Cimzia (certolizumab pegol), Entyvio (vedolizumab), Stelara (Ustekinumab), Xeljanz (tofacitinib) (UC only)
Ankylosing Spondylitis (AS):
Humira (adalimumab), Enbrel (etanercept), Remicade (infliximab), Cimzia (certolizumab pegol), Simponi (golimumab), Cosentyx (secukinumab), Taltz (ixekizumab)
Multiple Sclerosis (MS):
Tysabri (natalizumab), Ocrevus (ocrelizumab), Lemtrada (alemtuzumab), Kesimpta (ofatumumab)
Systemic Lupus Erythematosus (SLE) :
Benlysta (belimumab), Saphnelo (anifrolumab)
Atopic Dermatitis: Dupixent (dupilumab)
Leading Players in the Biologics Industry for Autoimmune Diseases
- AbbVie Inc.
- Amgen Inc.
- Johnson & Johnson
- Roche Holding AG
- Pfizer Inc.
Market Overview
The global market for biologics for autoimmune diseases is significant and is expected to continue growing at a robust rate. The size of the worldwide biologics market was estimated to be USD 511.04 billion in 2024 and is expected to increase at a compound annual growth rate (CAGR) of 10.4% to reach around USD 1,374.51 billion by 2033, according to recent research.
Autoimmune therapeutics: approved drugs and pipeline candidates
Pfizer is one of the leading pharmaceutical companies with a robust pipeline in the area of autoimmune disease therapeutics. Their efforts span various stages of development and target a wide range of autoimmune disorders. Here is an overview of Pfizer’s current pipeline and notable products in the autoimmune disease space:
Approved Products and their Indications :
Xeljanz (tofacitinib): Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ulcerative Colitis (UC), Ankylosing Spondylitis (AS)
Enbrel (etanercept): Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), Plaque Psoriasis, Juvenile Idiopathic Arthritis
Pipeline Candidates, their indications and current developmental phase :
PF-07264660
- Indication: Atopic Dermatitis
- Stage: Phase II clinical trials
Ritlecitinib
- Indications: Alopecia Areata, Vitiligo
- Stage: Phase III clinical trials
VELSIPITY
- Indications: Crohn’s Disease, Ulcerative Colitis
- Stage: Phase II clinical trials
Dekavil
- Indications: Rheumatoid Arthritis, Alopecia Areata
- Stage: Phase II clinical trials
PF-06835375
- Indications: Crohn’s Disease
- Stage: Phase II clinical trials
PF-07899895
- Indications: Ulcerative Colitis
- Stage: Phase I clinical trials
AbbVie is a prominent player in the field of autoimmune disease therapeutics, with a diverse pipeline aimed at addressing various autoimmune disorders. Here’s an overview of AbbVie’s pipeline of drugs for autoimmune diseases:
Approved Products and their Indications :
Humira (adalimumab):
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), Crohn’s Disease, Ulcerative Colitis (UC), Plaque Psoriasis, Juvenile Idiopathic Arthritis, Hidradenitis Suppurativa, Uveitis
Skyrizi (risankizumab):
Plaque psoriasis, Crohn’s disease
Rinvoq (upadacitinib):
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Atopic Dermatitis, Ulcerative Colitis (UC), Ankylosing Spondylitis (AS)
Pipeline Candidates, their indications and current developmental phase :
ABBV-599
- Indication: Systemic Lupus Erythematosus (SLE)
- Stage: Phase II clinical trials
ABBV-154
- Indications: Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS)
- Stage: Phase II clinical trials
ABBV-257
- Indication: Inflammatory Bowel Diseases (IBD)
- Stage: Phase II clinical trials
ABBV-105
- Indications: Rheumatoid Arthritis (RA), Lupus Nephritis
- Stage: Phase II clinical trials
ABBV-3373
- Indication: Rheumatoid Arthritis (RA)
- Stage: Phase II clinical trials
ABBV-621
- Indications: Various autoimmune and inflammatory diseases
- Stage: Phase I/II clinical trials
RG6237 (partnered with Roche)
- Indication: Sjogren’s Syndrome
- Stage: Phase II clinical trials
Key Issues Affecting Access to Biologics
- Cost and Insurance Coverage: Biologics are often very expensive, and not all insurance plans cover biologics, and those that do may require high copayments or strict prior authorization processes.
- Healthcare Infrastructure: For biologics that require intravenous infusion, access to infusion centers can be a barrier.
- Regulatory and Policy Issues: Navigating the complex regulatory landscape for approval of new biologics and biosimilars can be challenging and time-consuming. Varying policies on reimbursement for biologics can impact access.
Biologics have revolutionized the treatment landscape for autoimmune diseases, offering new hope to millions of patients worldwide. They have significantly improved the quality of life for autoimmune patients, enabling better disease management and symptom control. Ongoing efforts in research, policy support, and patient advocacy will be essential to maximize the benefits of biologics and ensure that all patients can access these life-changing therapies.
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