Biotech Values

[bladerunner1717]

I'm sorry to be so dense, Dew, but I still don't quite get it.

Authorized generics do not have their own brand name; rather, they are referred to by their chemical name (e.g. enoxaparin in the case of a Lovenox generic).

If a physician prescribes Valium for his patient, the doctor usually writes the prescription for "diazepam." (The manufacturer on the bottle could be Mylan, DAK, Alpharma, etc.) But these are clearly not authorized generics, but they are referred to by their chemical name. So if the authorized generic and these branded generics are both referred to by their chemical name, how is the patient/consumer to know which is the authorized generic? In other words, simply telling me that the authorized generic is referred to by its chemical name doesn't seem very useful, because there are many generics for Valium and they are all referred to by their chemical name.

This, by the way, is not merely an academic discussion. When my friends taking Wellbutrin XL asked me how they could be sure that they were getting the "real" drug (by which they meant the original branded drug), I told them--mistakenly, I now think, after reading what you and biomaven had to say--to make sure that they were getting the branded or authorized generic. But, if I understand you correctly, asking for the branded generic wouldn't have helped them. (Teva and Impax are the defendants in the Wellbutrin XL case. Two other generic makers of Wellbutrin XL are not being sued: Watson Pharmaceuticals and Anchen Pharamceuticals. The reason the latter two companies are not being sued is because they tried to more closely follow the sustained release techology that the original branded drug manufacturer, GSK, had used.) So if a patient gets a prescription for "Budeprion XL," the chemical name for Wellbutrin XL, the patient could be getting any one of four different drugs from four different manufacturers, none of which is authorized.

As a layperon/patient, I want to know that I'm getting the identical drug as the original branded one. The nomenclature in this area is highly confusing. It would make sense to me if there were a category called authorized branded generic to distinguish it from any run-of-the-mill branded generics.

I believe GSK licensed the rights to Wellbutrin XL to Biovail. I assume that Biovail charges more than the generic version for its drug. However, if I were a patient being prescribed Wellbutrin XL, I would surely want the Biovail version. Here's part of an article detailing some of Biovail's opinions on Teva's proposed clinical trials for Budeprion XL (The trials starting AFTER Teva got sued, of course. LOLOL):


"Budeprion XL is already deemed to be bioequivalent to Wellbutrin XL(R) by the FDA as defined by existing standard FDA criteria. Biovail believes this determination is likely to be confirmed by the proposed new trial.

However, based on available information, an independent expert retained by Biovail to consider the matter noted, "Even if Wellbutrin XL(R) and Budeprion XL were found (again) to be bioequivalent according to FDA bioequivalence criteria, the failure to find systematic differences in AUC and Cmax in the study does not exclude the possibility of other between-product differences affecting clinical response."

Biovail believes the size of the proposed Teva study, while much larger than needed for bioequivalence testing, is likely too small to demonstrate that Wellbutrin XL(R) 300 mg and Budeprion XL have similar safety, tolerability, and/or efficacy profiles. In addition, the eight-day treatment periods in the proposed trial may be too brief for a clinically meaningful result, since most antidepressant clinical trials require treatment periods of at least 28 days.

To meaningfully address the reports of inefficacy and adverse events, Biovail's expert believes that a more extensive re-randomized trial should be conducted. In such a study, a larger number of subjects, both those who have and have not reported difficulties upon being switched from Wellbutrin XL(R) 300 mg to Budeprion XL in the past, would be assigned to Wellbutrin XL(R) and placebo Budeprion XL under double-dummy conditions. During the study, groups of subjects would be re-randomized to Budeprion XL and placebo Wellbutrin XL(R), or continued on their original treatment.

Based on the views of its outside expert, Biovail believes a much larger and differently designed trial than has been proposed by Teva is required to demonstrate what, if any, clinical differences exist between Wellbutrin XL(R) 300 mg and Budeprion XL.

Biovail's primary concern is the safety and well-being of patients."


By the way, I checked Wikipedia on Wellbutrin XL and the article there makes a distinction betweea a branded drug and a generic drug, but makes no mention of any such thing as an authorized generic. I think, as biomaven pointed out, most people still use branded generic and authorized generic interchangeably.

I propose, again, the term branded authorized generic.

I plan to call my friends for the mistake that I made and urge them to use only the Biovail product, when their doctors prescribe Wellbutrin XL (and not accept a prescription for "Budeprion XL").

Also, notice Biovail's term, "existing standard FDA criteria." I wonder if there has ever been a court challenge to the FDA's criteria for a generic. The Wellbutrin XL case would seem to me to raise the issue, although the FDA is not named as a party in the case.


Bladerunner