While Obama’s new Healthcare Reform laws have given approval to the next generation of lower cost, breakthrough drugs, called “biosimilar” drugs, these drugs will apparently not be required to undergo the same intensive clinical trial scrutiny as most other drugs. And while these drugs are similar, they are not the same and surely carry additional and different risks. Biosimilars are virtually identical formulas of drugs previously approved by the FDA; however, these “follow on-biologic” drugs are compounded drugs that are subsequent versions of innovator biopharmaceutical products – the are NOT generic drugs.
The safety record of biosimilar drugs, according to recent reports from “The Hill”, indicate that Congress will allow the FDA to base its approval of biosimilars, in part, on the safety and efficacy record of the original breakthrough drug, rather than conducting new clinical trials. This will allow drug companies to put their drugs on the market much faster.
Unlike the more common small-molecule drugs, biologics generally have a high molecular complexity, and may be quite sensitive to manufacturing process changes. The follow-on manufacturer does not have access to the originator’s molecular clone and original cell bank, nor to other processes necessary to manufacturer the drug safely. All they have access to is the commercialized innovator product. Health experts warn that differences in impurities and/or breakdown products can have serious health consequences, which was shown by a few instances in which manufacturing changes for innovator biologics led to adverse events . Naturally, this has created a concern that copies of biologics might perform differently than the original branded version of the product.
Although the principle for low cost, accessible pharmaceuticals is obviously very appealing, many medical experts remain firm that these drugs are not safe without thorough clinical trials to analyze their safety and efficacy. Pharmaceutical companies have consistently proven that their priorities are not consumers, but their own profits, and the competition to put the next great product on the market may cause safety protocols to be overlooked – leading to a new round of lawsuits involving biosimilars.