Chemical & Engineering News just published its take on the FDA's progress towards establishment of a biosimilars approval process. The publication writes, "Fights over testing requirements, data exclusivity, and even how to name these so-called biosimilars, or follow-on biologics, are delaying the agency from putting an approval process in place."
FDA now has to decide how much testing is necessary to show that a biosimilar is as safe and effective as the original product. But there is much disagreement over exactly how much clinical testing FDA should require. Because of the complexity of protein-based drugs, FDA is finding it difficult to strike the right balance between the desire for low-cost biologics and the need for careful evaluation of safety and efficacy.
On one side of the debate are the biotech companies and patient groups, which insist that the complexity of biological products makes animal toxicology studies and human clinical trials essential for establishing safety and efficacy. They argue that, “A biosimilar product will invariably be made up of a different mixture of related molecules than the product it is attempting to copy. The challenge with biosimilars is knowing which structural variations matter clinically and which do not.” Makes sense, huh?
On the other side of the debate are the generic drug manufacturers that claim that clinical testing for biosimilars is redundant and unethical because it has already been performed on the original products. They argue that if biosimilars producers have confirmed that their product is “highly similar” to a reference biologic with state-of-the-art analytical tools, then that biosimilar “should be subject to clinical study requirements only to the same degree as is expected for originator products making manufacturing changes.” Such requirements typically do not involve clinical testing. Makes sense, huh?
FDA has begun the process of establishing a biosimilars approval pathway, but observers say it will likely be several years before the agency sorts through all the challenges related to implementing the new law.
So stay tuned, and read the whole article, entiled "Untangling Biosimilars".
Posted by Bruce Lehr December 4th 2010.