Eli Lilly and Boehringer Ingleheim recently announced that the FDA has granted “tentative” approval of their insulin glargine injection, which they plan to market as Basaglar in the US (1).
But the drug won’t be available to patients for some time. Sanofi has filed a lawsuit claiming patent infringement of their insulin glargine drug, Lantus. Under the Drug Price Competition and Patent Term Restoration Act, this means an automatic stay of up to 30 months while the case comes to court.
The drug was filed through the FDA’s 505(b)(2) regulatory pathway, which considers the safety and efficacy of existing drugs alongside data from clinical trials of the new drug. In Europe, the drug is considered a biosimilar and has been recommended for EMA approval by the advisory Committee for Medicinal Products for Human Use (CHMP).
Hospira is also unhappy. A temporary restraining order blocking the sale of generic versions of its patented sedative, Precedex, has been lifted (2). It was only last month that Hospira brought the lawsuit against the FDA and two companies planning to sell the drug (Mylan and Par Sterile). It was a US district court judge that issued the restraining order, but now the court has issued a summary judgment in favor of the FDA and generic drug makers.
Hospira called the FDA’s approval of the copycat drugs “arbitrary and capricious” and warned that the decision is likely to lead to substantial job losses – most of the Precedex sales team will probably be axed. The company is taking its case to the court of appeals, and has asked for another restraining order to be granted until it can be heard.
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References
- Boehringer Ingelheim Press Release, “FDA Grants Tentative Approval for Lilly and Boehringer Ingelheim’s Basaglar™ (insulin glargine injection)” (August 18, 2014). RTT News, “Mylan, FDA Granted Favorable Summary Judgment By Court On Generic Precedex” (September 8, 2014).
