Journal Publishes Letter on Banning Animal Testing for Biosimilars

A letter penned by Sarfaraz K. Niazi, PhD, advocating for the banning of animal testing requirements for biosimilar development was published in Science.

The publication comes 48 years after the journal published another letter written by 10 scientists, 6 of whom went on to becomes Nobel Laureates, recommending extensive animal testing for recombinant products they had discovered, signaling that the journal has softened to idea that animal testing may not be as useful as originally thought.

In addition to being the founder of Pharmaceutical Scientist, Novel351k, and Adello Biologics, Niazi is an adjunct professor of biopharmaceutical sciences at the College of Pharmacy at the University of Illinois at Chicago and a patent law practitioner. He is also a member of the The Center for Biosimilars^® Advisory Board.

The letter publication follows Niazi’s announcement of the Congressional introduction of S 4288, a bill that he created with Senator Ben Ray Luján (D-New Mexico). If passed, the bill would remove the mention of animal studies from the Biologics Price Competition and Innovation Act, the US regulatory framework that established the biosimilars approval pathway.

In his letter, Niazi argued that regulatory agencies need to update their policies to do away with animal testing to streamline the biosimilars approval process. He also contended the animal testing is unnecessary to prove the safety and efficacy of biosimilars and is considered unethical.

“Policies requiring animal toxicology studies to test biosimilars often stipulate the use of a dose multiple times as high as the human dose. This strategy fails to recognize that higher doses lead to nonlinear responses, which invalidates the results,” Niazi wrote.

A big issue Niazi raised about animal studies is they often use animal species that don’t have all the binding receptors humans have for drugs to target. They may have similar receptors that bind to drugs at concentrations different from those in humans but the lack of adequate receptors in animals could lead to inaccurate documentation of adverse effects and drug responses.

Although the FDA still requires animal toxicology studies for biosimilars, the agency is considering alternative models of testing innovative drugs and lower-cost alternatives, such as biosimilars and generics. In many cases, the FDA has discarded most of the animals studies that have been submitted for biosimilars, of which a biosimilar may have been tested in dozens of them prior to human testing.

The European Medicines Agency is the only global regulatory agency to update its policy in a way that reflects that animal pharmacology and toxicology studies offer little benefit in the evaluation of biosimilars.

Niazi concluded, “More than 120 biosimilars have been approved in the United States and the European Union, and no results from the required animal studies have yielded useful information about responses or side effects in humans. It is time for regulatory agencies to forbid animal testing for biosimilar approval for the sake of animal welfare, cost, and time.”

Reference

Niazi SK. End animal testing for biosimilar approval. Science. 2022;377(6602):162-163. doi:10.1126/science.add4664