Biologic medications have revolutionized numerous therapeutic areas and saved countless lives. The development of biologics has transformed therapeutic areas, improved patient outcomes, and managed previously untreatable conditions.7 This two-part blog post discusses how biologics have transformed various therapeutic areas.Biologics are medications from living organisms such as humans, animals, and microorganisms. Biologics include vaccines, blood components, tissue, somatic cells, gene therapy, and recombinant products. While small-molecule drugs are made from pure chemical substances and easily reproducible, biologics require a more complicated manufacturing process, and each medication contains slight variations. From 2022 to 2030, Precedence Research predicts the global biologics market size will reach a value of $719.84 billion. The biologics market will expand as chronic diseases become more prevalent, patents for branded biologics expire, and more advanced diagnostics become available.The life sciences industry's future lies in biologics. Whether you are a medical science liaison (MSL) or an aspiring MSL, understanding how biologics have evolved and their current status in the market is vital. With this knowledge, you will better understand the biologics market’s strengths, weaknesses, opportunities, and threats, i.e., SWOT analysis. Biologics have affected every area of medicine, but the introduction of biologics has transformed some therapeutic areas more than others. Dermatology, immunology, endocrinology, ophthalmology, and oncology are 5 therapeutic areas that have experienced a rapid improvement in patient care due to the emergence of biologics. Part one discusses biologics' effects on dermatology, immunology, and endocrinology. The second part will focus on ophthalmology and oncology. After explaining the types of biologics, we will discuss how they have impacted therapeutic areas and disease states.

What Are the Types of Biologics?

A broad range of drugs is classified as biologics with many mechanisms of action. However, the underlying intention of many biologics is to target specific areas of the immune system, enhancing the body’s immunity and reducing disease symptoms. Gene therapy is a biologic aiming not just to treat symptoms but to cure diseases. Other types of biologics include:

• Blood or platelets
• Steroid hormone therapies
• Vaccines
• Antitoxins (Botox)
• Recombinant proteins (Insulin)
• Recombinant nucleic acids ( genetic hypercholesterolemia)
• Interleukins (immune molecules for infections and cancers)
• Monoclonal antibodies (autoimmune diseases and cancer)
• Stem cell therapies (cancers or genetic diseases)
• Other cell therapies (specific T cells used to treat cancer)
• Gene therapies (rare diseases and conditions with an underlying genetic origin)

Biologics undeniably play a vital role in many therapeutic areas, and their use will only continue to increase as the population ages and demand increases. Dermatology, endocrinology, immunology, ophthalmology, and oncology are five therapeutic areas experiencing a rapid improvement in patient outcomes due to biologics. The most commonly used type of biologic is a monoclonal antibody. One of the factors driving the demand for monoclonal antibodies is COVID-19. Studies have shown when treated with monoclonal antibodies, patients with mild-to-moderate COVID-19 experience less risk of disease progression.1 The rise and growth of biologics are also due to advancements in drug development, including artificial intelligence (AI) and funding for research provided by pharmaceutical companies. Currently, there are 621 biologics with FDA approval, and oncology biologics are one of the fastest-growing segments of the life sciences. Figure 1 displays critical milestones in the biologics market.

Biosimilars are a new class of biologic drugs using the original biologic as a template. Biosimilars are “highly similar” to their reference product (original biologic). Biosimilars present a market challenge to biologics as they are less expensive versions of biologics.

However, the uptake of biosimilars has been relatively slow for various reasons, including provider knowledge and patent lawsuits.7 In 2023, biologics will face more marketplace challenges as more biosimilars enter the market than in any previous year. However, biologics have an established history of efficacy and safety compared to biosimilars, enabling their continued uses in multiple therapeutic areas.

1. Dermatology

Currently, biologics account for 37% of dermatology products in development. The first dermatologic condition treated by a biologic is psoriasis. Psoriasis occurs when the immune system fails to regulate T-cells. Biogen’s alefacept (Amevive®), FDA-approved in 2003, was the first biologic approved by the FDA to treat moderate to severe plaque psoriasis. Since this initial breakthrough, the FDA approved nine additional biologics for treating plaque psoriasis.3 Currently, there are three types of biologics FDA-approved for treating psoriasis:

• Tumor necrosis factor-alpha (TNF-a) inhibitors were the first class of biologics to treat moderate to severe psoriasis patients. Enbrel® was the first TNF-a inhibitor to gain FDA approval (2004), followed by Remicade® (2006) and Humira® (2008).6
• Interleukin-12/23 (IL-12/23) antagonist is the second class of biologics to receive FDA approval for psoriasis. The drug Stelara®, approved by the FDA in 2009, targets cytokines IL 12/23, which are directly involved in the pathogenesis of psoriasis.
• Interleukin-17 (IL-17) inhibitors include Cosentyx® (2015) and Taltz®, which received approval in 2016. They target IL-17, a cytokine responsible for skin inflammation.

Before the FDA approved these biologics, psoriasis patients lacked adequate treatment options. Many biologics target similar immune system components as part of their mechanism of action. As a result, branded biologics have expanded their indications over the years to include other autoimmune disorders.

2. Immunology

Many diseases have immune-mediated pathogenesis.2 Since biologics affect the immune system, biologics are used for numerous autoimmune diseases. These include ulcerative colitis, Crohn’s disease, and psoriatic arthritis. The biologics used to treat forms of arthritis are called disease-modifying antirheumatic drugs(DMARD).Humira was initially developed for rheumatoid arthritis before its indication as a psoriasis drug. Humira’s® indications have expanded over the years to include:

• Ankylosing spondylitis
• Juvenile Idiopathic Arthritis
• Crohn’s disease
• Ulcerative colitis
• Hidradenitis suppurativa
• Uveitis

A slate of potentially 10+ biosimilar competitors will launch against Humira® (adalimumab), the world's best-selling drug of all time, in 2023. Cardinal Health provides a quick overview of Humira® biosimilars for HCPs and patients to gain an understanding of Humira® biosimilars in 2023.

3. Endocrinology

More than 37 million people in the U.S. have diabetes, meaning 1 in 10 Americans suffer. In 1982, Humulin® became the first insulin biologic approved by the FDA.4 After Humulin®’s approval in 1982, multiple insulin therapies entered the market, including the first interchangeable biosimilar, Semglee®. An interchangeable biosimilar is a biosimilar that can be substituted for a reference product without the intervention of the prescriber. This practice is sometimes called pharmacy-level substitution. As a result of Semglee®'s approval, people with diabetes will have greater access to insulin, and insulin costs may decrease.How can interchangeable biosimilars reduce the cost of biologics? Here are a few ways:

• Increasing competition
• Reducing the cost of medications for patients without requiring a provider's intervention. (pharmacy-level substitution)
• Prescribing incentives from government programs (e.g., 340B drug reimbursement)

Some healthcare facilities can acquire drug products at a substantially lower cost through the 340B Drug Pricing Program. Participating manufacturers agree to provide outpatient drugs at substantial discounts to Medicaid-eligible hospitals and clinics. As a result, more patients can access expensive medications, including biologics and biosimilars. 2023 will be a pivotal year for biologics as more biosimilars will enter the market than in any previous year. With increased competition, biologics’ ability to dominate therapeutic markets may diminish. Biologics have a history of efficacy and success in each therapeutic area, which may enable them to maintain market share by leveraging this strength.In November 2022, the ACMA will offer the first and only recognized and accredited Board Certification program specializing in biologics and biosimilars. The certificate is intended for all life sciences industry members and provides the opportunity to showcase your expertise in the rapidly growing biologics and biosimilars market. Learn more about the Board Certified Biologics and Biosimilars Specialist Program (BCBBS) here. Return to ACMA’S blog next week to read part 2 regarding biologics in ophthalmology and oncology. References 1.Gupta A, Gonzalez-Rojas Y, Juarez E, et al.. Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab. New England Journal of Medicine. 2021;385(21):1941-1950. doi:10.1056/nejmoa2107934.2. Johnston SL. Biologic therapies: what and when? [published correction appears in J Clin Pathol. 2007 Mar;60(3):336]. J Clin Pathol. 2007;60(1):8-17. doi:10.1136/jcp.2005.032300.3. Kamata M, Tada Y. Efficacy and Safety of Biologics for Psoriasis and Psoriatic Arthritis and Their Impact on Comorbidities: A Literature Review. Int J Mol Sci. 2020;21(5):1690. Published 2020 Mar 1. doi:10.3390/ijms21051690.4. Kinch MS. An overview of FDA-approved biologics medicines. Drug Discov Today. 2015;20(4):393-398. doi:10.1016/j.drudis.2014.09.003.5. Menter, A., Krueger, G.G., Paek, S.Y. et al. Interleukin-17 and Interleukin-23: A Narrative Review of Mechanisms of Action in Psoriasis and Associated Comorbidities. Dermatol Ther (Heidelb) 11, 385–400 (2021). doi:.6. Oberoi R, Schuett J, Schuett H, et al. Targeting Tumor Necrosis Factor-α with Adalimumab: Effects on Endothelial Activation and Monocyte Adhesion. PLoS One. 2016;11(7):e0160145. Published 2016 Jul 28. doi:.7. Stiff KM, Cline A, Feldman SR. Tracking the price of existing biologics when drugs enter the market. Expert Rev Pharmacoecon Outcomes Res. 2019;19(4):375-377. doi:.