Safety and effectiveness are the issue, claim the drug companies. Because a generic drug manufacturer cannot make a drug that is exactly the same as the original drug, the public might be put at risk. Alterations to the drug will result in generic drugs that are less effective than the original drug or, even more serious, that could be dangerous to the user
This article brings up some good points, but all is points can be countered using the opposite point. Alterations to the class of drugs the reporter is talking about, could be bad, but they could also be good. The only thing you can do is make serious guess on what will happen when something changes based on complex models. This reporter has no data to back up his/her suggestions that allowing generic drug manufactures to bring biopharmaceuticals to market will result in dangerous drugs. I could suggest that the variations the companies introduce could actually make safer more effective drugs, and my argument would be just as valid.
The are essentially arguing the fact that small variations in the process could have major effects in the outcome of the drug (basic chaos theory 101). They fail to mention any positive outcome of the changes, and mention only the negative. All they suggest is that more law be put in to place to handle the problem, which since both of those are lawyers, that would make sense.