Why do we need generic biopharmaceuticals (biogenerics)?
Given the technology that is necessary to produce biopharmaceuticals, prices of these products are exceedingly high in contrast to traditional pharmaceuticals. For example, treatment with Genentech’s colon and breast cancer drug Avastin® costs $100,000 per year, while Cerezyme®, a drug used to treat a genetic condition, is priced at an average of $170,000 per patient per year. Access to affordable, generic versions of these biopharmaceuticals will alleviate the resulting financial stress on our nation’s health care system and allow all Americans to enjoy the benefit of these advances in biotechnology. Unfortunately, the FDA currently lacks a clear pathway for approving affordable biopharmaceuticals and bringing them to market. Although many companies are interested in developing and manufacturing generic biopharmaceuticals, they cannot invest in or move forward with research without a clear approval infrastructure. Congress must establish a definitive, efficient FDA approval process fo
