The FDA has approved the first generic version of the blockbuster low molecular weight heparin Lovenox (enoxaparin sodium), much to originator sanofi-aventis’s displeasure. Sanofi-aventis has expressed concerns about the generic’s safety and, according to a report from Reuters, has even asked a court to block the approval, claiming that the FDA’s decision was “arbitrary and capricious”.
“Sanofi-aventis is concerned by potential implications for patient safety, since the product approved has not been subjected to extensive clinical trials to demonstrate its efficacy and safety,” said Sanofi, in a company press statement.
Sanofi’s main reservation relates to the complexity of Lovenox, which is a mix of sugar molecules derived from pig intestines. According to Sanofi, the product’s efficacy and safety profile relies on “strict adherence” to specific manufacturing processes, as well as traceability from the animal mucosa to the finished product.
No doubt Sanofi will also be concerned about the financial implications of the approval. Lovenox was Sanofi’s second biggest selling product in 2009, with US sales of approximately $2.7 billion. The product, which can help prevent deep vein thrombosis, is also claimed to be the best-selling hospital medicine in the US. Sanofi had initially believed that Lovenox was under patent protection until 2012; however, in 2007 a US court found that the patents were unenforceable when challenged by generic companies Teva and Amphastor.
On the other side of the fence, Sandoz and Momenta, who collaborated on the development of the newly FDA-approved generic, are both celebrating, despite Sanofi’s threat in its company press statement of utilising all appropriate analytical and clinical avenues to assess the quality and safety of the generic.
"Sandoz is the first company to launch generic enoxaparin sodium in the US, delivering on our strategy of being first-to-market with key products, and underscoring our leadership in differentiated products," Jeff George, Global Head of Sandoz, said in a press statement.
Meanwhile, Teva is hoping that Sandoz and Momenta’s success will also lead to the approval of its pending generic version of Lovenox. However, the generic manufacturer also has reason to be concerned by the FDA’s approval of such a complex generic product. Its proprietary multiple sclerosis medicine, Copaxone, which also requires complex manufacturing procedures, is due to go off patent in the coming years. In a press statement commenting on the FDA’s approval of generic Lovenox, Teva adds that: “any potential generic version of Copaxone should be evaluated via preclinical and full-scale, placebo-controlled clinical trials with measured clinical endpoints in multiple sclerosis patients to establish safety, efficacy and immunogenicity in a real patient population.”