Branded

A new bill (HB 365) in Florida's state legislature would allow pharmacists to substitute biosimilars for branded biotech drugs, according to published reports. The Sarasota Herald-Tribune reported that the Health Quality Subcommittee of the Florida House of Representatives approved a bill that would allow for substitution while requiring pharmacists to notify prescribing physicians within five days and require the doctor and pharmacist to maintain a record for at least four years. A similar bill (SB 732) is pending in the Florida Senate, according to reports.

WASHINGTON — Employers that use multiple cost-management programs have a 50% lower specialty drug trend than those that don't use them, according to a new study by pharmacy benefit manager Express Scripts.

The study, presented Thursday at the National Business Group on Health's Business Health Agenda 2013 conference in Washington, was described as one of the first to examine the effect of multiple utilization management programs on the cost of specialty medications, which is expected to account for $1 out of every $4 spent on prescription drugs by 2014.

WASHINGTON — Several senators have requested that the Government Accountability Office look for ways to coordinate the efforts of law enforcement and public health agencies at various levels and nonprofit organizations to address prescription drug abuse.

PRINCETON, N.J. — Ranbaxy Labs will market a drug for depression under an agreement with another company, the drug maker said Tuesday.

Ranbaxy said it had entered an in-licensing agreement with Alembic Pharmaceuticals to market desvenlafaxine base extended-release tablets. Alembic is the sponsor of a new drug application filed with the Food and Drug Administration for the drug, which is bioequivalent to Pfizer's Pristiq. Pristiq had sales of $590 million during the 12-month period that ended in January.

PHILADELPHIA — The Food and Drug Administration has accepted a regulatory application for a new painkiller from Iroko Pharmaceuticals, the drug maker said Monday.

Iroko is seeking approval for a lower-dose, submicron diclofenac, a non-steroidal anti-inflammatory drug for treating mild to moderate acute pain in adults.

NEW YORK — The Centers for Disease Control and Prevention last week set the stage for the first quadrivalent influenza vaccine to be introduced in the 2013-2014 flu season, according to a report in The Wall Street Journal. 

Quadrivalent vaccines will contain two A strains and two B strains of flu. The triumvirate vaccines in use today contain two A strains and one B strain of flu. 

TOKYO — The Food and Drug Administration has approved a once-monthly treatment for schizophrenia.

Otsuka Pharmaceutical and H. Lundbeck announced the FDA approval of Abilify Maintena (aripiprazole) for extended-release injectable suspension, an intramuscular depot formulation indicated for the treatment of schizophrenia.

The companies described Abilify Maintena as the first dopamine D2 partial agonist approved as a once-monthly injection, contributing to a new treatment option to address the ongoing need for relapse prevention in patients with schizophrenia.

WASHINGTON — The Supreme Court will hear arguments later this month in a case that could determine the future of many patent settlements between brand and generic drug makers.

The high court will hear arguments in the case, Federal Trade Commission v. Actavis, on March 25. The case was originally titled FTC v. Watson, but has changed since Watson Pharmaceuticals changed its name following its acquisition of Swiss generic drug maker Actavis.