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biotech_researcher

10/25/13 7:06 AM

#168771 RE: DewDiligence #168740

Food for thought in responses to this article:

"But generic drugmakers argue that the same policy that governs nomenclature for existing medicines should also apply to biosimilars and would changing the current system that is used for drugs globally would confuse physicians"

The generics companies are being a little disingenous here in implying that giving biosimilars the same INN as originator drugs that they mimic would be a continuation of existing policy. Historically, every chemically unique drug has had a unique INN. The biosimilars are in most cases mixtures of proteins with different glycosylation patterns from the original drug. Being chemically different, providing them with unique INNs would be a continuation of existing policy.

biotech_researcher

10/25/13 7:10 AM

#168772 RE: DewDiligence #168740

More "food" for thought on the naming issue w/ biosimilars, going down the path of GMO??

From 10/10/13
"Based on data submitted by Watson, FDA has determined that that company’s generic bupropion HCl ER 300 mg tablet product is not therapeutically equivalent to Wellbutrin XL 300 mg."
Some General Facts
Number of atoms in typical chemical pharma products like bupropion ~21
Number of atoms in typical monoclonal antibody products like Etanercept ~21,000
So are we really sure auto substitution sounds like its protecting the health of America, geez its bad enough we can't tell what Food is GMO in our country.