Sanofi is seeking to block Novartis from selling the generic version of Lovenox. A federal court refused to stop sales of the product, approved by the FDA July 23, pending the outcome of an August 17 hearing.
Meanwhile, Sanofi is pursuing Genzyme, maybe, instead of or in addition to making an 'authorized' generic version of their product...
To underscore a point Peter made, analysts who think that the approval of generic Lovenox will unleash a flood of follow-on biologics had better readjust their sights and projections. Or at least read the FDA's approvable letter to Novartis and Momenta:
Meanwhile, Sanofi is pursuing Genzyme, maybe, instead of or in addition to making an 'authorized' generic version of their product...
To underscore a point Peter made, analysts who think that the approval of generic Lovenox will unleash a flood of follow-on biologics had better readjust their sights and projections. Or at least read the FDA's approvable letter to Novartis and Momenta:
"Low weight molecular heparin (LMWH) is made by breaking-up heparin into smaller chains of sugars, for example, via chemical reactions. Different chemical reactions can produce chains of various sizes, composition, and sequences. These factors can alter the absorption, distribution, metabolism, excretion, and efficacy of this drug in the body2,3— one reason why FDA classified each brand name LMWH product as a distinct chemical entity (e.g., enoxaparin sodium, dalteparin sodium, ardeparin sodium, tinzaparin sodium).
The chemical reaction used to make enoxaparin sodium results in oligosaccharide fragments of distinctive sizes and sequences. It also modifies the chemical structure of sugar residues at both ends of the fragments. Such chemical modifications may affect the activity of this drug.4 If a manufacturer wants to make a generic enoxaparin sodium, it has to design a manufacturing process that is capable of reproducing these distinct features of the drug. Otherwise, a generic enoxaparin sodium might not behave in the same way in the body as the brand name counterpart, Lovenox.
Thus, demonstration of “sameness” for enoxaparin sodium requires “state-of-the-art” analytical methods to show that the structural features of oligosaccharides in the generic enoxaparin sodium are equivalent to those in Lovenox.
In addition to these highly sophisticated tests, it is also important to show equivalence of functionality based upon anticoagulant activity, for example, by measuring activated partial thrombolastin time (aPTT) or the inhibition of factor Xa and factor IIa (two critical elements contributing to human blood clotting activity), as well as demonstrating similar behavior of the profiles of these anticoagulant activities in humans. Such tests provide additional assurance of equivalent efficacy of the drug."
www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm220023.htm
Note to analysts: sameness is not interchangeability with all products. It requires testing. And post market monitoring. Reproducing is NOT copying and it is NOT bioavailability. It is equivalence of functionality based on activity. It has to work the same way and be designed in ways that produce such functional equivalence.
There are lots of IP landmines in making a "bio-same-ilar", which explains the Sanofi suit. Meanwhile, the Genzyme play, moving towards targeted, even fractional market, based on narrow therapeutic pathways and complex manufacturing is consistent with what other companies are doing.
The blockbuster model is dead and the era of equivalence is over.
www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm220023.htm
Note to analysts: sameness is not interchangeability with all products. It requires testing. And post market monitoring. Reproducing is NOT copying and it is NOT bioavailability. It is equivalence of functionality based on activity. It has to work the same way and be designed in ways that produce such functional equivalence.
There are lots of IP landmines in making a "bio-same-ilar", which explains the Sanofi suit. Meanwhile, the Genzyme play, moving towards targeted, even fractional market, based on narrow therapeutic pathways and complex manufacturing is consistent with what other companies are doing.
The blockbuster model is dead and the era of equivalence is over.
