FDA approves first biosimilar enoxaparin sodium

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FDA approves first biosimilar enoxaparin sodium

Biosimilars/News | Posted 13/08/2010 2 Post your comment

On 23 July 2010, Momenta Pharmaceuticals and Sandoz announced that they had received approval from the FDA for their biosimilar version of sanofi-aventis’s (sanofi-aventis’s ) blockbuster blood thinning drug, Lovenox (enoxaparin sodium).

This comes as a major blow to sanofi-aventis who were not predicting FDA approval of the biosimilar due to the complex nature of enoxaparin. Lovenox is the leading hospital-based medication in the US and in 2009 sales were US$2.7 billion. However sanofi-aventis is trying to remain positive, adding that “Lovenox sales outside of the US have been growing faster than in the US and represent more than 40% of Lovenox total sales in 2009”.

Sanofi-aventis considering legal action

In a statement issued by sanofi-aventis the company expressed its concern about “potential implications for patient safety, since the product has not been subjected to extensive clinical trials to demonstrate its efficacy and safety”, adding that the Momenta/Sandoz version “has not been assessed on the basis of an extensive clinical programme showing proven and comparable clinical efficacy and safety to Lovenox”. The company also stated it will “assess the quality, efficacy and safety of the product and is considering all appropriate legal options”.

First biosimilar but others to follow soon

M-Enoxaparin, the biosimilar Momenta/Sandoz version, is the first biosimilar enoxaparin to be launched in the US and both companies are reported to be extremely pleased.

Global Head of Sandoz, Mr Jeff George, welcomed the FDA decision and said that “we are now looking forward to significantly increasing patient access to this vital medicine, by providing a high-quality, more affordable version".

President and CEO of Momenta, Mr Craig Wheeler, commented that “this is the first product based on Momenta’s technology platform to be approved, and demonstrates our ability to characterise and develop a complex mixture drug like Lovenox”.

The FDA action could get a legal challenge from US-based generics maker Amphastar, which has had an abbreviated new drug application (ANDA) pending at the FDA since 2003 for a biosimilar version of Lovenox. While Israeli generics’ giant Teva “believes that it has demonstrated to the FDA that its version of generic Lovenox meets their criteria and that its’ pending ANDA is approvable”.

References:

Momenta Pharmaceuticals Announces FDA Approval for First Generic Lovenox. 23 July 2010

Sandoz Press Release and News. Sandoz leads the way with first generic version of 'gold standard' anti-thrombotic Lovenox. 23 July 2010

Sanofi-aventis Press Release. Sanofi-aventis expresses concern

over the approval of another version of enoxaparin sodium in the U.S. 23 July 2010

Teva Press Release. Teva Comments on Generic Lovenox Approval. 23 July 2010

Comments (2)

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Posted 27/05/2011 by RGS

Re: FDA approves first biosimilar enoxaparin sodium

@ Ronald, I think you may have missed the point. The idea of biosimilar does not have to neccesarily imply that it is a biologic, its just that this is where it has most commonly been associated. A biosimlar is much like a bioequivalent, however the bar is much lower. Rather than showing that it is exactly the same as the innovative drug (i.e. 'bioequivalent') the generic must only show that it is substantially similar. The reason for this is becuase large molecules such as Lovenox, whose structure is not definded, cannot be shown to be bioequivelent, even to themselves (i.e Lovenox is not one molecule, there are varying lengths of chains). Instead, Momenta has illustrated that their product acts in a 'substatially similar' way. This type of approach has already been implemted in many jurisdiction around the world such as Europe and Canada and recognizes that even outside the world of biotechnology drug molecules are becoming very complex and the exact structure may not be that important. The FDA is just catching up.

Posted 16/08/2010 by Ronald A. Rader

Re: FDA approves first biosimilar enoxaparin sodium

Lovenox, a low molecular weight heparin (LMWH), was not approved as a biosimilar, i.e., using the newly U.S. law that hasn't even been implemented yet by FDA, and it is not even a biologic or biopharmaceutical. It was approved by FDA as a common generic drug. Lovenox and other LMWHs are the products of the break down of purified heparin polysaccharide into large fragments. The source heparin is isolated from dead pig intestinal inner walls using very harsh chemical and physical methods (e.g., acid, boiling). There is nothing "bio" or "biotech" about heparin and LMWHs! These are regulated and approved in the U.S. as drugs (although I recall that they qualify for biosimilar approvals, in the EU; perhaps the source for the mistake). Like many other natural products, these are chemical substances derived from dead tissues, with no bioprocessing or bio-transformations (i.e., no biotechnology involved). Would you consider a generic morphine, taxol/paclitaxol, digitoxin, estrogens and other hormones (e.g., from those from horse and human urine) etc., to be biopharmaceuticals or eligible for biosimilar approval? How is heparin and LMWHs any different, other than being a complex, hard or impossible to fully characterize mixture of organic molecules, like essentially all organiic molecules, originating at some time from living organisms?

Ronald A. Rader
Author / BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets (www.biopharma.com)

Biotechnology Information Institute 1700 Rockville Pike, Suite 400 Rockville, MD 20852 Phone: 301-424-0255 (9AM-5M Eastern U.S.) E-mail: biotech@biopharma.com Web site: www.biopharma.com