Biologics and Biosimilars Reshape Care With Targeted Therapies and Cost Savings
Both biologics and biosimilars are transforming patient care by delivering more targeted therapies and expanding access through cost savings, according to Andrew Darkow, PharmD, MBA, BCPS, during his presentation at the American Association of Pharmacy Technicians 2025 Annual Convention in Denver.
Biologics are built from living sources such as bacteria, yeasts, and animal cells and have dramatically reshaped treatment for complex diseases, including cancer, autoimmune disorders, and inflammatory conditions. Unlike conventional drugs, which are smaller and chemically synthesized, biologics are larger, complex, and often require injection due to their unique production methods. This precision enables biologics to target disease mechanisms more directly, reducing adverse events and improving outcomes for many patients.
Biosimilars are highly similar to their reference biologic products, possessing no clinically meaningful differences in efficacy, safety, or administration. They are identified by a 4-letter suffix, ensuring clarity in prescribing and dispensing. Regulatory distinction is key; biosimilars demonstrate equivalence, not superiority, via streamlined approval pathways. This leads to substantial cost savings. In fact, biosimilars contributed an estimated $12.4 billion in US health care savings in 2023 alone, helping patients access previously unaffordable treatments.
One major challenge for biologics and biosimilars is immunogenicity. Due to their protein complexity, the body may identify these drugs as foreign, risking immune responses that can reduce effectiveness or trigger hypersensitivity reactions. Rigorous clinical and regulatory testing is required to ensure safety across diverse patient populations.
“Our bodies don't like foreign sources. They like the things that it creates itself. There is a risk with biologic and biosimilar products that your body will produce an immune response against that biologic product… If your body produces antibodies against the biologic product, it can decrease its effectiveness,” Darkow said. “By neutralizing that biologic, it can alter the kinetic coherence of the medication and the way that our body distributes it, and it can cause hypersensitivity reactions if our body mounts an allergic response against that biologic. This is why biologics and biosimilars have to undergo rigorous immunogenicity testing.”
Biologics and biosimilars have fundamentally changed health care delivery, offering targeted options for diseases that were once difficult to treat. Biosimilars, acting much like generics for biologics, increase competition, expand treatment access, and ease financial pressure on health systems. However, professionals must remain informed about evolving regulatory standards, interchangeability requirements, and potential state-specific prescribing restrictions.
Reference
Darkow A. Decoding the Logic: An Overview of Biologics and Biosimilars. Presented at: American Association of Pharmacy Technicians 2025 Annual Pharmacy Technician Convention. Denver, CO. June 5–7
Pharmacy Times. Understanding Biologics and Biosimilars Amid an Evolving Treatment Landscape. Published June 12, 2025. Accessed September 12, 2025. https://www.pharmacytimes.com/view/understanding-biologics-and-biosimilars-amid-an-evolving-treatment-landscape
