The FDA Approves A Generic Lovenox
5 CommentsBy Ed Silverman // July 23rd, 2010 // 11:39 am
After five-plus years of anticipation, the FDA has approved a generic version of Lovenox, a $4 billion blood thinner sold by Sanofi-Aventis. The approval comes after a three-way race between Momenta Pharmaceutical, which received the agency endorsement, and two others - Amphastar Pharmaceuticals and Teva Pharmaceutical. There is no word on approval for the rival meds (here is the FDA statement).
In a word, this is really about biologics and the implications are enormous. “Lovenox is technically not a biologic, yet functionally and effectively it is,” writes Sanford Bernstein analyst Tim Anderson in an investor note. “Many in industry have felt that if FDA ultimately approves generic versions of Lovenox and it makes those generics fully substitutable - which it just has - then this might signal what FDA may also ultimately do when it comes to ‘true’ biologics that generic companies are also pursuing.” Lovenox, he reports, has pre-tax margins of 72 percent.
So who wins and who loses? This is a negative for biotech and brand-name drugmakers with biologics, notably Sanofi which, at one point, filed a Citizen’s Petition with the FDA to thwart approval. As Rodman & Renshaw analyst Simos Simeonidis points out in his own investor note: The approval makes “the possibility of approvals for similar products much more tangible.” One exception is Novartis, because the drugmaker’s Sandoz generic unit has a partnership deal with Momenta. For generic drugmakers and also third-party payers, this is obviously good news.
As an aside, the Momenta application at the FDA was also the subject of skullduggery involving Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, and Momenta scientists, who were among a team of researchers that identified a contaminant in Chinese-imported heparin marketed by Baxter International that killed patients. Amphastar alleged that Woodcock’s research work with Momenta created the appearance of a conflict, although the allegation was recently dismissed as unfounded (back story).
Dr. Talluri
Enoxaparin (Lovenox) is a low molecular weight heparin made from the heparin extracted from pig intestines. It is technically a biologic and more (may be not entirely) similar to the biologics (IgG, albumin, alpha 1 antitrypsin etc- Major players-CSL Behring, Baxter, Talecris, Grifols ) that are extracted and purified from human plasma. The basic proteins are same, because they all come from human plasma; but the purification and the concentration process of those proteins is proprietary for an individual company which allows them specific trade names. Example: 10% IgG is called Privigen (CSL Behring), Gamunex (Talecris), Gammagard (Baxter). These products are approved through different pathway. They do not call them generics when a new brand is approved.
I am not sure through which pathway this “GENERIC” from Sandoz/Momenta is approved. It is another version of the low molecular heparin derived from the pig intestine heparin–perhaps purified by different mechanism?
The pathway is probably entirely different for BIOLOGICS and their BIOSIMILARS.
murat
Enoxaparin (Lovenox) is a low molecular weight heparin made from the heparin extracted from pig intestines. It is technically a biologic and more (may be not entirely) similar to the biologics (IgG, albumin, alpha 1 antitrypsin etc- Major players-CSL Behring, Baxter, Talecris, Grifols ) that are extracted and purified from human plasma. The basic proteins are same, because they all come from human plasma; but the purification and the concentration process of those proteins is proprietary for an individual company which allows them specific trade names. Example: 10% IgG is called Privigen (CSL Behring), Gamunex (Talecris), Gammagard (Baxter). These products are approved through different pathway. They do not call them generics when a new brand is approved.
Dr. Talluri
This is strange. It is a carbon copy of my commentword for word. What is going on here?
Phyllis Polikoff
I have been prescribed a 7 day/twice per day dosage of Lovenox in 60 mg/.6 ml imjections. I can do this myself as I have self-injected for arthritic problems (Kineret, Emberel, etc.). I wish to know more about the company who makes Lovenox or the generic for same. Hope this is not a problem for Momenta? Thanking you in advance, Phyllis Polikoff - PPolikoff@AOL.COM
mary anastasia billek
My name is Mary and I have been on Warfin because of blood clots found in my heart and in my lungs. I was informed that Lovenox was my only hope in stabilizing my coumadin levels. I have no insurance and need your help in to get my levels stable so I can go back to school and finish my degree and get my life on track. Lovenox was prescribed from my doctor but the only way I can have it administered is being admitted to the hospital where my bill would be added to a charity case. I was told I would have to be on Lovenox for several days once released from the hospital and then on Warfin for 6-8 months. At the moment my coumadin levels are at 1.6 and my heart doctor wants them at 2.5 and up. Everytime my level has been checked even with the increased dosage of warfin my level keeps dropping. Lovenox is my only hope to getting my levels to the amount needed to hopefully stop me from getting anymore clots. I’m only 47yrs old and I keep missing many days of school because I have to keep having my levels checked. Please help me finish my dream to get my degree in medical billing and coding,move out of my mother’s house,get my own apartment or house and be able to stand on my own. All I’m asking is for you to fund my Lovenox injections so I can get myself to the level needed so I will now longer have to worry about blood clots…Please help me
Sincerely yours, Mary Anastasia Billeck