Rheumatoid Arthritis Support Group
Rheumatoid arthritis is a chronic, inflammatory, multisystem, autoimmune disorder. It is a disabling and painful condition which can lead to substantial loss of mobility due to pain and joint destruction. The disease is also systemic in that it often also affects many extra-articular tissues throughout the body including the skin, blood vessels, heart, lungs, and...
The 2010 healthcare reform bill included a provision calling on the FDA to create an expedited pathway for approving biosimilars -- the nonidentical "generic" versions of advanced prescription drugs to treat multiple illnesses from cancer to rheumatoid arthritis. The FDA may issue guidance on the subject any day now.The primary concern for the FDA is how to ensure that a biosimilar is the same as its original biologic.
Crucial differences separate "generics" from biosimilars. Most traditional drugs, like Tylenol, are chemically synthesized, which means they have structures that are consistent and known. Biologics, on the other hand, are fashioned out of living cells, meaning they have much more complex structures, which are not as easily understood as the makeups of chemically created drugs.Because a chemically created drug can be reproduced easily, the generic versions are no different than their name-brand counterparts and can be verified through testing and analysis.
With biosimilars this is not always the case. That's because biologics are more complex structures that are much more difficult to replicate. An error in reproduction could cause unanticipated or harmful side effects.www.medpagetoday.com
Crucial differences separate "generics" from biosimilars. Most traditional drugs, like Tylenol, are chemically synthesized, which means they have structures that are consistent and known. Biologics, on the other hand, are fashioned out of living cells, meaning they have much more complex structures, which are not as easily understood as the makeups of chemically created drugs.Because a chemically created drug can be reproduced easily, the generic versions are no different than their name-brand counterparts and can be verified through testing and analysis.
With biosimilars this is not always the case. That's because biologics are more complex structures that are much more difficult to replicate. An error in reproduction could cause unanticipated or harmful side effects.www.medpagetoday.com
I'm thinking I want the real thing! Thanks so much for this information. I had no idea this was even being considered.
They may have the same chemical formula, but different arrangement (could be as simple as a cis or trans change; or even more complicated, might have a straight chain instead of a cyclic formation) and therefore may not be effective or as effective. A very good example is Cyclosporin. There are several generics available, all, but one, have different bioavailabilities when compared to the brand name.
Unless I know for sure, I want the brand. Especially when it comes to biologically based meds.