by Oliver Yu
Compounding the complexity, even biologics that appear chemically the same have unique structural fingerprints as a result of the way protein structure assumes its functional shape, a process known as “folding.” Because biosimilars are so difficult to develop, they sometimes don’t work as effectively as the innovator biologic drug.
I wonder if the author knows how innovator biologic drugs are manufactured. If he did, he'd know that these drugs are produced in batches and that controls must be in place to ensure that the drug product is the "same" from batch-to-batch.
Biologics are complex due to their size. Their efficacy depends on not just their chemical composition, but on their shape. But there are ways to provide a high degree of assurance that the drug product is effective.
In computer science, there's a concept called, "Checksum." A checksum is a "fingerprint" for digital data... no two pieces of digital data produces the same "fingerprint." In the world of QC drug testing, there is a concept called peptide mapping. This is where you digest the protein with enzymes, chopping it at specific places. Then you take the chopped-protein and run it through a chromatography column and see what order the parts come out. The order the parts come out is a "fingerprint" for the molecule.
As for the activity of the drug product, you can test that a biosimilar trastuzumab binds to the HER2 protein. I mean, that's how they tell if you are HER2+ in the first place.
I'm not saying that biosimilars ought to get rubberstamped with lower standards. I'm saying that the vast majority of biologics manufacturing requirements of the innovator drugmaker can be ported over to biosimilars and that these putative hurdles described by our journalists are dated and not applicable given the modern technology available.