FDA moves forward with approval of generic Abilify from 4 different manufacturers despite Otsuka pushback

May 7, 2015

FDA’s approval of generic versions of Abilify (aripiprazole), an antipsychotic drug approved to treat schizophrenia and bipolar disorder, from 4 different generic manufacturers, has industry insiders pondering the generic drug market.

FDA’s approval of generic versions of Abilify (aripiprazole), an antipsychotic drug approved to treat schizophrenia and bipolar disorder, from 4 different generic manufacturers, has industry insiders pondering the generic drug market.

According to the Wall Street Journal, the approvals come after Otsuka cited complex regulatory law to thwart generics, but FDA rejected the argument and decided that generic versions meet the standard for approval. Otsuka has sued FDA in a federal district court in Maryland and requested an injunction that would have stayed the effectiveness of any FDA approvals of ANDAs for generic aripiprazole. That injunction was subsequently denied by the Maryland court.

This has been a closely-watched effort, according the WSJ, because, if successful, other pharmaceutical manufacturers may have been encouraged to pursue a similar strategy to prevent generic competition, which could pose a significant risk of further raising healthcare costs for consumers.

Related:FDA approves first generic Abilify

According to a recent IMS Health report, Abilify was ranked number 1 among the 10 top-selling drugs in the United States by total sales, at an estimated $6.4 billion.

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Santilli“Not only will the FDA decision be positive for generic makers, but may also be a win for patients as it may serve as a warning to other drug makers who are developing similar strategies to prevent generic competition,” said John Santilli, partner, Access Market Intelligence, in Trumbull, Conn.

This also serves as a boost for formulary managers as they have continued to promote the use of appropriate generic products, according to Santilli.

“All classes of blockbuster drugs-including antipsychotics-that are losing their brand status present an opportunity for health plans and pharmacy benefit managers to encourage the use of generic products,” agreed Nadina J. Rosier, PharmD, Towers Watson North America HGB Practice Leader, Pharmacy.

“As a result of generics becoming available, many PBMs are implementing more restrictive formularies with drug exclusions across various therapy classes when clinically viable generics are now available,” she said. “This practice generates significant savings for employers.”

As blockbuster brand drugs lose patent, plan sponsors will look for ways to shift utilization to low net cost products covered by the benefit vis-à-vis formulary, plan design, and/or step therapy approaches, according to Dr. Rosier.

Rosier“Today, we are seeing many employers with more than 85% of claims dispensed as generic products,” she said.

The Towers Watson 2015 Emerging Trends in Health Care Survey showed that 61% of surveyed employers are either adopting a high-performance formulary that eliminates brand coverage while encouraging generic use or planning to do so in the next 2 to 3 years.

Santilli believes that FDA’s approval of the generic versions of Abilify may be a setback for Otsuka Pharmaceuticals. “Otsuka may have already implemented a plan to fill this gap by acquiring Avanir in December 2014,” he said.

However, this is a potential windfall for the generic makers Alembic Pharmaceuticals Ltd.Hetero Labs Ltd., Teva Pharmaceuticals and Torrent Pharmaceuticals Ltd., according to Santilli.

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