2025: Biotherapeutics, Year in Review

Despite the major political and economic changes marking much of this past year, 2025 was actually a landmark year for biotherapeutics. The FDA approved 16 biosimilars throughout the year, and innovation surged, with the FDA approving several “non-canonical” antibody formats: Two ADCs – Datroway for HR-positive, HER2-negative metastatic breast cancer, Emrelist for c-Met-high NSCLC – and one bispecific antibody, Lynozyfic, for relapsed or refractory multiple myeloma.

Let’s take a look at some industry trends and shakeups over the past year to see what we can anticipate for 2026.

Shakeups in Preclinical and Clinical Research

Early in the year, the FDA unveiled a plan to reduce animal testing in mAb development, shifting regulatory requirements toward the use of AI and clinically relevant non-animal (e.g., in vitro) models (NAMs), such as organoids. The initiative aims to improve safety, speed drug evaluation, reduce R&D costs, and encourage innovation by allowing real-world human data and non-animal methods to support regulatory decisions. The policy marks a significant shift expected to accelerate patient access to safer, more predictive, and affordable therapies. To further support this goal, regulators also prioritized biosimilar affordability by proposing streamlined approval pathways and lowering the number of clinical trials (across all modalities) required for drug approval.

While these changes could put patients in a much better place long-term, in the short term, they force drug developers to think more concretely about which NAMs will support their current and future preclinical R&D.

CMC Gaps and Cracks

In 2025, an increasing number of BLAs received Complete Response Letters, driven not by safety or efficacy concerns, but by manufacturing and quality deficiencies. CMC gaps emerged as a central bottleneck for antibody therapeutics. With complex biotherapeutics, including bispecifics and ADCs advancing toward approval, many programs encountered delays due to stability issues and insufficient analytical characterization. These trends underscored the need for earlier manufacturability assessments and deeper preclinical analytics to keep antibody programs on track for first-cycle approval.

Drug Repurposing

GLP-1 receptor agonists were huge winners this year. While initially developed for diabetes and later adopted for obesity management, this year saw expansion into a broader therapeutic landscape. A growing body of research points to emerging roles in cardioprotective effects, liver disease, obstructive sleep apnea, osteoarthritis, neurodegenerative disorders, and substance use disorders.

Where Are Biologics Headed in 2026?

The events and trends of 2025 will shape the biotherapeutics world in 2026.

With the events and shakeups of 2025 fresh in our minds, the focus in 2026 will be on 1) rigorous, streamlined, lower-cost preclinical characterization using NAMs, 2) manufacturability optimization, and 3) applicability of these to complex antibody formats such as ADCs. That means de-risking promising candidates early, accelerating progress toward IND-enabling studies, ensuring alignment with ever-evolving regulatory expectations, and partnering with a provider that can deliver trusted, end-to-end biotherapeutics discovery and development services.

At Eurofins Discovery, our characterization services deliver the early, in vitro insights needed to navigate today’s complex biotherapeutics landscape, using high-throughput binding assays, kinetic profiling, and a broad suite of biochemical and functional assays to confirm mechanism of action, identify off-target or Fc-mediated risks, and rapidly prioritize the strongest candidates. Our deep expertise in ADC development and antibody engineering allows us to support programs with binding and specificity assessments, functional and cytotoxicity screening, and advanced analytics such as drug-antibody ratio (DAR) determination, ensuring each molecule is evaluated for both therapeutic potential and safety liabilities.

We also perform comprehensive manufacturability assessments, bringing developability, stability, and biophysical insights forward into early-stage candidate selection to de-risk issues such as aggregation, sequence liabilities, expression challenges, and purification bottlenecks. By pairing functional performance with data on stability, forced degradation, and other critical CMC attributes, Eurofins helps teams select molecules that not only demonstrate therapeutic promise but also scale efficiently, reducing downstream manufacturing surprises, strengthening regulatory packages, and creating a smoother path from discovery to the clinic.

2025: Biotherapeutics, Year in Review

Shakeups in Preclinical and Clinical Research

CMC Gaps and Cracks

Drug Repurposing

Where Are Biologics Headed in 2026?

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