Thursday, July 29, 2010

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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1 comment :

Ron said...

Lovenox is not a biosimilar! It is not even a biologic.

Lovenox (enoxaparin) was not approved through the new "biosimilars" approval mechanism for biologics that became law late last year. Lovenox was not even a regulated/approved as a biologic. It is simply a generic drug, approved by well-established Hatch-Waxman generic drug regulations. Enoxaparin is chemically derived from heparin, a complex natural product drug purified from dead pig intestines. There is nothing "bio(tech)" about Enoxaparin - no manufacture from or by living organisms, no bioprocessing or biotransformations involved -- It's just a breakdown product of a complex natural product.

And Lovenox was not the first biopharmaceutical to receive generic drug approval, with actual biopharmaceuticals approved as generic drugs include versions of recombinant somatropin (human growth hormone) and calcitonin and non-recombinant hyaluronidase. These are true biopharmaceuticals - made in real-time by living organisms, not harshly chemically and physically extracted from inanimate glop (meat processing wastes) as heparin is, which is then further chemically broken down to low molecular weight heparin (Lovenox).

Ronald A. Rader
Author & Publisher of BIOPHARMA:  Biopharmaceutical Products in the U.S. and European Markets
Biotechnology Information Institute
E-mail:  biotech@biopharma.com
Web sites:  www.biopharma.com; www.bioinfo.com; www.biosimilars.com

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