Biotech Strategy Blog

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

Posts tagged ‘Momenta’

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

2 Comments

The news, reported by Bloomberg, last week that generic companies may be subject to stricter FDA standards in order to show therapeutic equivalence is good news for the biotech industry and consumers.

Generic companies have a pretty easy ride in obtaining product approval, and I’ve long been convinced that the formulation of a brand, and what makes it work can include the so called inactive ingredients and how it is put together.   I know of many people who have experienced side effects with generics that they don’t have with the branded product.

For this reason, branded generics from the original manufacturer have the ability to retain some market share in the face of generic competition.  Sandoz, the generic arm of Novartis uses this strategy to good effect with many mature products.   However, if companies instead want to try and maintain a premium priced brand and not adapt to the entry of generics, then they will find their market share erodes extremely fast. Not only is brand market erosion fast with generic drugs, but with biosimilars too.

As reported by Reuters, sales of generic enoxaparin sodium injection, Momenta’s copy of Sanofi’s anti-thrombotic, low molecular weight, heparin sold as “Lovenox” were $292million in the third quarter of 2010. Sandoz markets enoxaparin on behalf of Momenta. They launched the product on July 23, and achieved  $292 million of sales in 69 days. With annual sales forecast to be over $1billion, the biosimilar will be a blockbuster and make a significant dent in the $2.9 billion sales of Lovenox in 2009.

The Boston Business Journal reports that Sandoz/Momenta have captured 60% market share already, which is not good news for Sanofi-Aventis and may explain their desire to make acquisitions such as Genzyme to make up for this loss.

Biosimilars that are fully substitutable for the original product, look likely to erode brands extremely fast.  Momenta’s success is good for the biotechnology industry and highlights the future market opportunity from development of biosimilars.

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