Amphastar’s biosimilar enoxaparin approved by FDA

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Amphastar’s biosimilar enoxaparin approved by FDA – Momenta launches lawsuit

Biosimilares/Novedades | Posted 30/09/2011 0 Post your comment

On 19 September 2011, and after years of conflict with FDA, Amphastar Pharmaceuticals (Amphastar) finally received approval to market a biosimilar version of sanofi-aventis’s blockbuster blood-thinner Lovenox (enoxaparin). The announcement, however, was closely followed by news that Momenta Pharmaceuticals (Momenta) had launched a lawsuit against Amphastar.

US-based generics maker Amphastar has had an abbreviated new drug application (ANDA) pending at FDA since 2003 for its biosimilar version of enoxaparin. Meanwhile, Momenta and Sandoz received approval from FDA for their ANDA for biosimilar enoxaparin back in July 2010 [1].

Amphastar has a distribution agreement with Watson Pharmaceuticals (Watson), under which Amphastar will supply enoxaparin to Watson, who will then market, sell and distribute the product to retail pharmacies in the US. Amphastar will receive between 50–55% of Watson’s gross profits on product sales, depending on the number of competitors in the market. Amphastar will market, sell and distribute generic enoxaparin to all other channels.

Lovenox (enoxaparin) is a low molecular weight heparin used to prevent deep vein thrombosis which can lead to blood clots in the lungs.

For the 12 months ending on 30 July 2011, Lovenox and its generic equivalents had total US sales of approximately US$2.6 billion, according to IMS Health. Amphastar is currently preparing for launch and anticipates launching its enoxaparin sodium injection product in the fourth quarter of 2011.

There is much at stake, therefore it is not surprising that Momenta and Sandoz have hit back with a lawsuit against Amphastar and Watson. The suit, filed on 21 September 2011, alleges that Amphastar’s enoxaparin sodium injection product infringes on two of Momenta’s US patents. One patent is related to methods of processing enoxaparin to determine the presence of certain tetrasaccharide structures. The second patent is related to methods of analysing enoxaparin for the presence of a certain structural signature.

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Reference

1. GaBI Online - Generics and Biosimilars Initiative. FDA approves first biosimilar enoxaparin sodium [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 September 30]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-first-biosimilar-enoxaparin-sodium

Source: FDA, FDAnews, Momenta, Watson