Abbvie sues EMA, reports the Financial Times

March 11, 2013 | By Márcio Barra

While many are clamoring for more data transparency from pharmaceutical companies to allow outside review of the safety and efficacy data, many companies fear that this trend will expose critical commercial information to rival companies.

Those fears might not be unfounded, as the Financial Times reported that AbbVie, a spin-off from Abbott created at the beginning of the year, just sought an injunction to block EMA from releasing clinical trial information of its blockbuster drug, Humira, as UCB was reportedly seeking Humira’s reports. UCB has a rival drug for rheumatoid arthritis, Cimzia, approved in the EU in 2009.

AbbVie filed two lawsuits against EMA at the European Union General Court in Luxembourg, issuing a statement where it says that it was “seeking to protect AbbVie’s confidential and commercially-sensitive information.”  and that it supports “transparency of clinical research and safety information for the benefit of patients and healthcare professionals [but not] the disclosure of commercially confidential information that does not meaningfully contribute to the scientific review or evaluation of our products.”

According to EMA, the majority of freedom of information requests it received for more clinical trial data came from drug companies, industry consultants and lawyers.

AbbVie/ Abbott’s move is not surprising when you take into account that while Humira’s is currently the world’s biggest selling drug, their overdependence on it can become a big issue down the line. Still, it’s a curious occasion to sue the European regulator when the outcry for more transparency is reaching new highs every day. There could be some harm on the public perception.


The Financial Times

John LaMattina Forbes blog

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