“This is why the FDA has set a much higher bar for designating a biosimilar as ‘interchangeable.’ We are not afraid of biosimilars. We need them, and they will result, in the long term, in better access [for] patients. However, we can’t enter into that situation blindly. Testing and safeguards must be put into place.”
Taking into consideration the complexities of development, a recent Health Affairs study states that the level of cost savings achieved with biosimilars will likely be below what was expected when the Biologics Price Competition and Innovation Act was signed into law in March 2010, at least for the near future.
“The ACR has identified several key questions, several things that have to be answered to proceed,” Dr. Huston adds. “We want to make sure the right policies are in place so that physicians can feel confident and comfortable telling the patient, ‘It’s OK to be taking a biosimilar.’ Patients right now ask us all the time if it’s OK to take the generic or the brand name for drug X. Most of the time (it is), but this is different. These drugs are just not the same, and before I can tell the patient it’s OK … I need to know that everything has been done to make sure that drug is going to be effective and safe.” (posted 3/17/15)
Richard Quinn is a freelance writer in New Jersey.
