Currently under consultations, the ‘Guidelines on Similar Biologics’ are closely aligned with regulations followed by global regulatory bodies, people aware of the development said. This is the second comprehensive overhaul of guidelines for biosimilars that was first released in 2012 and revised in 2016.
“The review would provide an opportunity to evaluate new developments and identify areas where the current guidance could be more flexible without compromising its basic principles and allow for the provision of additional explanation of the possibility of tailoring the amount of data needed for regulatory approval,” according to the draft guidelines.
ET has reviewed a copy of the document.
It seeks to restrict use of animals in testing. “The 3Rs principles for animal experiments (replace, reduce, refine) should always be followed to minimise the use of animals in testing,” it said.”Where in-vivo (tested in a living body or plant) safety studies are deemed necessary, a flexible approach that follows the 3R principles to maximise the readout of relevant data and minimise the use of animals in testing should always be followed,” it added.The industry has long been demanding that animal toxicology studies be waived for biosimilars where robust global clinical data and analytical comparability already exists.
The US Food and Drug Administration (FDA) last month announced an ambitious plan to phase out animal testing requirements for monoclonal antibodies (biotech drugs) and other therapies, replacing it with potentially more effective methods.
As per the draft guidelines, animal models are often not sensitive enough to detect small differences. “If a relevant and sufficiently sensitive in-vivo animal model cannot be identified, the manufacturer may choose to proceed directly to clinical studies, taking into account strict principles to mitigate any potential risk,” it said.
However, the draft stresses on in-vitro (lab-based or not in animals) studies.
