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Safeguarding human health during clinical research is critically important, but biotechnology has shown that this does not always have to mean using animals to test drug safety. A new study by the Biotechnology Innovation Organization (BIO) outlines alternatives to help reduce animal testing.
Currently, FDA and international (e.g., ICH) regulatory guidelines generally recommend testing novel monoclonal antibodies and biotherapeutics on animals before giving them to humans. However, out of concern for animal testing ethics and the high costs of using animals, the biotechnology industry has sought to reduce the use of animal testing by developing New Approach Methodologies (NAMs).
NAMs are testing methods that don’t rely on animals or move testing into lower-level species. These testing methods can include conducting computer simulations, using cell lines and other human cells, and/or relying on pre-existing human data. In cases where relevant NAMs are available, these approaches are considered more humane whilst maintaining human safety. NAMs also have the potential to be more translatable, affordable, and/or efficient.
BIO published a research paper on opportunities and insights from BIO Member Companies on using NAMs in nonclinical safety assessment. BIO reports in this publication successes and challenges with reducing reliance on animal testing and increasing use of NAMs based on an industry survey and real-world case studies gathered from BIO member companies.
The authors found that there has been success with replacing animal testing with NAMs to support regulatory submissions in specific circumstances for new biotherapeutics. These circumstances include 1) when a drug is in development for a serious and life-threatening disease, 2) when an animal model is not available for safety testing, and 3) when there is prior experience with the biology targeted by the drug. The authors go on to advocate for extending the use of NAMs, when scientifically justified, even when an animal model is available, and for drugs in development for less severe diseases, which is not currently accepted.
The authors of the research paper advocate for future updates to internationally recognized regulatory guidance to increase Industry confidence in submitting scientifically justified NAMs-based regulatory filings globally. “Pursuing a NAM-based strategy for safety assessment requires significant tolerance for regulatory risk given the lack of globally aligned and accepted guidelines,” BIO’s paper says. “Many companies (81% of survey respondents and 50% of case study examples) seek pre-filing advice from one or more health authorities to reduce regulatory uncertainty; however, based on survey responses, a potential lack of global regulatory acceptance plays a large role in whether companies are willing to use NAMs to replace animal studies.” Global harmonization is essential for effectively replacing animal testing with scientifically justified NAMs, as differing regional regulatory requirements can otherwise lead to redundant animal studies.
BIO’s BioSafe Initiative
The paper was organized by the NAMs Task Force, part of BioSafe, BIO’s preclinical safety committee. BioSafe includes more than 300 BIO members and seeks science-based responses to scientific and regulatory challenges and developments in preclinical safety evaluation of biopharmaceutical products. Each year, BioSafe hosts a face-to-face General Membership Meeting (GMM) that features presentations and networking sessions from industry and government institutions. Subsequently, BIO’s NAMs Task Force was formed from a proposal and presentation from a previous BioSafe GMM. On the 2025 BioSafe GMM, the paper was presented at BioSafe’s annual gathering, which was held April 7-9 in Basel, Switzerland this year.
BioSafe’s work is part of a natural process. The science and technology are rapidly advancing and outpace updates to regulatory guidance. In fact, the FDA has been responding to public and industry interest in NAMs with a gradual effort to move away from animal testing requirements. On April 10, 2025, the FDA announced that it would increase efforts to phase out use of animals in testing the safety of drugs and increase use of New Approach Methodologies (NAMs).
“With continued dialogue between regulators and industry and scientific innovation in the field, the use of NAM-based approaches to replace or reduce animal studies when scientifically justified can continue to expand,” it says.
The BioSafe committee within BIO is composed of biologics experts across industry. As the FDA suggested, BIO and its members are committed to working with the FDA to promote the implementation of NAMs for mAbs and ultimately reduce animal use in drug development.
