FDA issues draft guidance to reduce primate testing in monoclonal antibody development

USA—The US Food and Drug Administration has released draft guidance encouraging pharmaceutical companies to reduce or eliminate non-human primate toxicity studies during preclinical development of monoclonal antibodies.

This framework represents the agency’s latest effort to modernize how it evaluates these therapeutic products while helping companies move away from laboratory primate testing.

The FDA plans to prioritize human-relevant models when making regulatory decisions.

These alternatives include organoids, computational toxicology tools, and real-world data analysis.

The agency believes this shift will deliver significant financial benefits to the pharmaceutical industry, which currently spends up to $50,000 per animal for routine toxicology testing.

Macaque monkeys serve as the most common species for drug testing because they share considerable physiological similarities with humans.

Current FDA drug safety regulations require testing in two species: one rodent and one non-rodent mammal.

Beyond the substantial costs, the industry has expressed concerns about the practical challenges of primate testing, and many researchers face ethical dilemmas regarding their use in preclinical research and development.

FDA Commissioner Marty Makary stated on December 2 that the new approach will accelerate the time medicines reach the market while reducing research and development expenses.

He suggested these savings could potentially lead to lower drug prices when products enter the market.

Makary also highlighted new approach methodologies, which include 3D bioprinted tissues and organ-on-a-chip models, describing them as more effective and humane than traditional animal testing methods.

Contract research organization Charles River praised the FDA’s decision.

A company spokesperson told Pharmaceutical Technology that substantial data supports this transition, noting that the FDA has provided regulatory guidance allowing the industry to further embrace the 3Rs principle: replacement, reduction, and refinement.

This guidance builds on the FDA’s recent shift away from animal testing toward more effective, human-relevant models such as artificial intelligence and lab-based systems.

The agency initially introduced this approach for specific monoclonal antibody preclinical development.

Shortly before the FDA released its framework, the European Commission introduced Directive 2010/63/EU aimed at protecting animals as sentient beings.

The UK’s Medicines and Healthcare Regulatory Authority has also committed USD 79 million to support efforts to reduce animal testing nationwide.

The UK government specifically encourages pharmaceutical and biotech companies to consider alternatives like 3D bioprinted tissues and organ-on-a-chip models during preclinical testing.

Steve Bulera, corporate vice-president and chief scientific officer for safety assessment at Charles River, told Clinical Trials Arena that new approach methodologies will eventually dominate the field, though the transition will take time.