FDA approves first biosimilar

On Friday, the FDA announced its approval for the generic blood thinner Sanofi Aventis blood thinner Lovenox. This highly complex drug is the first and now sets a pathway for other generic copies of proteins to be approved. Due to the complexity of these molecules and how they are copied, there is still debate about how many safety trials should be conducted. (Source: The Great Beyond)

On Monday, Sanofi Aventis asked the US Court to withdraw it's approval on the drug, believing that they may have not tested for the same active ingredient in Levenox. They also stated in the papers they took to court:

"If not remedied, FDA's decision will cause Sanofi-Aventis irreparable harm and may result in entry into the market of a generic product that is not clinically equivalent to Lovenox with respect to safety or efficacy," Sanofi said in court papers.

Read more about Sanofi's request at Reuters.

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