Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology & Hematology

The race to bring a biosimilar version of Sanofi-Aventis’ low molecular weight heparin, Lovenox® (enoxaparin sodium), to market had three players, Momenta Pharmaceuticals in partnership with Sandoz, Amphastar Pharmaceuticals and Teva.

The winner was Momenta/Sandoz who (as mentioned in a previous post) recorded $292 million of sales in 69 days post launch.   As reported by the Wall Street Journal, Amphastar are now suing the FDA alleging the agency acted arbitrarily in delaying its imports of raw heparin.  There certainly seems to be no love lost between Amphastar and the FDA, who earlier this year alleged a conflict of interest between Janet Woodcock, the Director for the Center for Drug Evaluation and Research (CDER) and Momenta as a result of the collaboration that identified the contaminant in chinese heparin that killed patients in 2008.  Following an FDA investigation, Woodcook was cleared of any conflict of interest but announced she would not participate in the biosimilar approval decision.

In the run up to the approval, the FDA visited the manufacturing facilities for all three companies. Afterwards the status of the Amphastar application became less certain. Unlike Amphastar, both Teva and Sandoz had prior experience of obtaining FDA approval for biosimilar products.

Given the amount of money at stake, its easy to see why Amphastar are unhappy. However, alleging conflicts of interest and arbitrary practices does not exactly win friends and influence people.  I am sure the FDA have a credible factual basis for their decision making, in which case Amphastar is unlikely to get anywhere, other than generate negative publicity for themselves.  Others may differ in that opinion, and if you want to read a legal analysis of the Amphastar complaint, the FDA Law Blog’s post is worth reading. It also has a link to the actual complaint filed.

The more interesting question is when is the FDA going to approve the Teva biosimilar version of Lovenox®? When this happens, Sandoz’s first mover advantage will come to an end and further price erosion is likely. According to Reuters, analysts predict this may happen before the end of 2010.

Update: Amphastar gains FDA approval for generic Lovenox

As reported by Ed Silverman on Pharmalot (September 19, 2011), “Amphastar Pharmaceuticals has finally won approval to sell a generic version of Lovenox

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2 Responses to “Amphastar sues FDA”

  1. Reviewer

    You assume wrong. You’ll find out soon enough that not only does FDA have no factual basis, they were correct in calling Woodcock out on conflict of interest. They did what they did because they realized FDA was never going to give them a fair shake. Not knowing the facts is a real hazard in this business. Are you aware, for example, that Amphastar achieved sameness way back in 2007?

    • Pieter Droppert

      I am flattered that someone at Akin Gump, the lawyers for Amphastar in the complaint against the FDA are reading this blog. However, if you do wish to submit a comment and advocate for your client, I ethically think you should be open about your identity, especially when using an Akin Gump law firm computer. This blog is my personal opinion and you are more than entitled to disagree or to espouse the opinion that your client is paying for. The fact is that no allegations against the FDA and Janet Woodcock have yet been upheld, notwithstanding your opinion to the contrary. I think it is dangerous for lawyers and law firms to seek to engage social media while a lawsuit is pending.

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