Business briefs: Lilly, Novartis, Activartis, plus policy news
Eli Lilly and Boehringer Ingelheim have jumped into the biosimilars pool. The partners announced Monday that they have submitted a marketing authorization request to the European Medicines Agency for experimental long-acting insulin for type 1 and type 2 diabetes. The treatment LY2963016 is a new glargine product. The application is part of a 2011 deal in which the two companies agreed to develop and market diabetes drugs. Approval could put the Lilly/BI biosim up against branded competitors including Sanofi's Lantus.
A Phase III Novartis study is making a pre-play for Amgen/Pfizer's hold on the Enbrel psoriasis market. The drug maker announced Monday that its pipeline treatment AIN457 (secukinumab) “demonstrated superiority” over Enbrel on both efficacy and tolerability in a head-to-head comparison among moderate-to-severe plaque psoriasis patients. Monday's announcement is part of a portfolio of Enbrel digs over the past few weeks, first with the June 24 report that Sandoz was working on a look-alike version, and a study that found patients on lower-tech drugs can do just as well as they could on Enbrel.
FDA granted orphan drug status to Activartis' experimental brain cancer therapy AV0113, reports PMLive, which notes that this label is in addition to the orphan drug status granted earlier by the EMA. The experimental treatment is for an aggressive cancer called malignant glioma. Glioma refers to tumors that begin in the brain or spinal cord.
Generic drug makers may soon be responsible to ensuring their drug labels are in step with the latest regulatory findings. The proposed change—submitted to the Office of Management and Budget—would mean generics' labels would be held to the same standard as that of branded peers. Current rules require generics to have the same labels, and that all labels changes must be approved by the FDA for generics. This is even when makers of branded drugs update their labels if they get what the NYTimes calls important new information about their drugs. NYT notes that this new rule would compel generics makers to stay on top of this same information, and failure to do so “could make them liable if a court were to find they failed to warn patients about potential harms.”
The administration has eased healthcare reform reporting requirements for health exchanges, and will now rely on consumers to accurately report their income and insurance status, as opposed to requiring exchanges to verify the information consumers provide on these measures, reported the Washington Post, Friday. The change was announced over a long holiday weekend, and came two days after the Treasury announced that employer reporting requirements will be pushed off for another year. Friday's change will have an impact on the 16 states and the District of Columbia, which will be running their own exchanges. Washington & Lee law professor Timothy Jost told the WP that the new system isn't new for the government, and likened the honor policy to the same one that requires tax payers to report cash tips as income.