FDA waves through generic BMS antipsychotic
pharmafile | April 30, 2015 | News story | Manufacturing and Production, Sales and Marketing | Alembic, BMS, FDA, Hetero and Torrent Pharmaceuticals, Teva
The FDA has approved four generic versions of Bristol-Myers Squibb’s top selling Abilify, an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder.
The news will be a big blow to BMS as now Teva Pharmaceuticals, Torrent, Alembic and Hetero Labs have all been shown an FDA green light to market generic Abilify (aripiprazole) in multiple strengths and dosage forms.
“Having access to treatments is important for patients with long-term health conditions,” says John Peters, acting director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research.
“Healthcare professionals and consumers can be assured that FDA-approved generic drugs have met the same rigorous standards as the brand-name drug.”
Revenues for BMS’s leading treatment Abilify were only just reported along with its recent financials, and are up 3% to $554 million – but the firm shares the drug with Japanese partner Otsuka which would be taking a large chunk of that.
Generic prescription drugs approved by the FDA have the same quality and strength as the brand-name originals, and generic prescription drug manufacturing and packaging sites must pass the same quality standards as the brand-name offering.
Schizophrenia is a chronic, severe and disabling brain disorder. Around 1% of Americans have it and typically symptoms are first seen in adults younger than 30 years of age. These symptoms include hearing voices, believing other people are reading their minds or controlling thoughts.
Bipolar disorder (also known as manic-depressive illness) is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks.
Abilify also has an orphan drug designation for the treatment of Tourette’s syndrome, a nervous system disorder, in children.
BMS will be looking to new products now to patch up the holes in its portfolio that this latest news creates, as Lamberto Andreotti its chief executive recently noted: “We continued to advance our pipeline with key regulatory and clinical progress across our portfolio and invested in several important business development opportunities that will help strengthen our future portfolio.”
Brett Wells
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