Last month saw the first publicly announced approval by the US Food and Drug Administration (FDA) of a biosimilar submitted through the 351(k) pathway for a version of the anti-infective Neupogen marketed by Sandoz, a subsidiary of Novartis.
Whilst biosimilars are currently available in other markets, including Europe, “[this acceptance] is in some way indicating that the advent of biosimilars will also happen in the US,” Director of Strategic Initiatives at Harlan Ciriaco Maraschiello told this publication, and therefore there is more demand expected from the region for biosimilar preclinical services.
The preclinical contract research organisation (CRO) – recently acquired by Huntingdon Life Sciences – has already seen an increasing demand specifically for its biosimilars and biopharmaceuticals strategic advice services, but Maraschiello said demand will continue to grow across all its offerings as pharma firms begin to pay attention to this potentially lucrative market.
“More than $200 billion in biosimilar sales are expected in the US over the next 10 years if the versions of the biosimilars approved in Europe come to market,” he said. “This will probably influence the drug development strategy of several pharma companies in the country.”
Small molecules vs large molecules vs biosimilars
For a biopharmaceutical, “the regulatory preclinical and nonclinical development is always a case-by-case basis, even if you have recommendations provided by the ICH S6 guidance” Maraschiello told us.
“It is all about the understanding of the mechanism-of-action and quantifying the pharmacological effects, as well as having a clear definition of the target.”
However, “Everyone is still thinking about the TeGenero case,” he continued. “The interpretation of toxicological data obtained for an investigational biological molecule and its translation into humans is challenging when compared to small molecules, especially if there are unexpected events like an immunogenic reaction or an anaphylactoid reaction.”
In 2006, six patients involved in first in human studies of a trial of a monoclonal antibody drug (TGN1412) - developed by the now defunct German company TeGenero – fell into intensive care. The trial was run by Parexel at its facility in Northwick Park Hospital, London.
However, preclinical work for biosimilars is more straightforward, according to Maraschiello. “The safety package is reduced and focused on demonstrating safety ‘similarity’ including, when applicable, suitable biomarkers to demonstrate similarity in efficacy.”
And Biopharma-Reporter will be delving deeper into the issues affecting biosimilars with a free virtual event on September 26. Join four industry experts as they discuss the development, manufacture and sale of such products in a 60 minute seminar hosted by our Editor-in-Chief Gareth Macdonald. Click here for more details...