Generic Lovenox – Moving One Step Closer to Biosimilars

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We bleed from similar veins.

– Tupac Shakur

Lovenox is not, I repeat, not a biologic therapeutic.  It is derived from a biological source (pig intestines, yum), but it is not protein-based.  However, the FDA’s approval of a generic form has a rather interesting bearing on the future of biosimilars.

But first, the basics:  Lovenox (enoxaparin sodium for injection) is an anti-coagulant that has a variety of uses including as a method of preventing serious clotting conditions like deep vein thrombosis (DVT).  It is made from heparin, which is a complex arrangement of sugars.  Lovenox was developed by sanofi-aventis; the approved generic was developed by Momenta Pharmaceutical and Novartis.  (Two other companies were in the race to get a generic Lovenox approved: Teva and Amphastar)

Ok, so what does this approval of a generic sugar-based drug have to do with biosimilars?  While it is not protein-based, it is an extremely complicated molecule to make and refine.  More importantly, these complications are similar to the kinds of complications that arise when attempting to reproduce a protein (eg, a biologic drug product).  Before this, many believed that if a generic Lovenox was ever approved, it would be a bellwether for FDA approvals of biosimilars.

In a Momenta Pharmaceuticals investor note, analyst Tim Anderson said:

“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.”

Does this mean that biotechs and blockbuster biologics from Big Pharma need to worry about encroaching generic competition?  Maybe.  I’m still not 100% convinced that the “biosimilar pathway” (which, to be clear, hasn’t been defined yet) will be significantly easier than developing and filing a standard BLA.  However, maybe this is an indication that the FDA wants to keep the burden of proving biosimilarity lower.

According to Forbes, Jeff George (CEO of Novartis’ Sandoz) had this to say:

“It underscores that the FDA really does have the institutional courage to approve affordable high quality alternatives to some of the more difficult-to-make products that are out there. There were a lot of interests lined up against this approval.”

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Breaking News Update – I wouldn’t work in an industry that moved slowly, so I’m not surprised that, even though I just wrote this, there’s already been an update:  sanofi-aventis sues FDA over generic approval (via Pharmalot and FDA Law Blog)

Related articles:

• Sanofi asks U.S. court to block generic blood thinner (reuters.com)
• Novartis Exec: Golden Age Of Generic Biotech Drugs Is Coming (blogs.forbes.com)
• FDA approves generic version of Sanofi’s Lovenox (marketwatch.com)

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