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Generic drugs make global strides

BY Alaric DeArment

While the U.S. generic drug market has grown at a rapid pace, the international market for generic manufacturing and use has grown as well.

Last month, the India Brand Equity Foundation released an overview of that country’s generics market, saying it was "now at the precipice" of its next development stage, and noting that India’s drug exports — mostly generics — had grown more than 21.5% over the last three years and accounted for more than $13 billion in annual sales, as nearly 40% of the regulatory approval applications for new generics at the U.S. Food and Drug Administration came from Indian companies last year.

Meanwhile, the Southeast Asian generics market is poised for growth. CPhI, a group sponsoring a drug industry summit in Bangkok this month, said the region’s industry was projected to grow to $3.9 billion by 2016 as a variety of factors — including stable economies, population growth and government policies — drove generics. Among these were the Indonesian government’s plans to have 90% of the population receiving health coverage within four years.

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FDA hikes GDUFA fees

BY Alaric DeArment

The Food and Drug Administration is raising the fees that generic drug companies will have to pay when filing for regulatory approval for new products or supplemental applications for existing products, the agency said last month.

The fee increase is the latest development in the implementation of the Generic Drug User Fee Amendments to the Prescription Drug User Fee Act, which Congress passed last year. The generic drug industry had pushed hard for the amendments, known as GDUFA, amid a long-standing backlog of regulatory applications for generic drugs that the agency lacked the financial or staffing resources to review in a timely fashion.

As of July, the agency said it had reviewed more than 30% of the backlogged applications and streamlined the hiring process to recruit new staff, with the expectation that it would meet its year-one GDUFA hiring goal by bringing on at least 25% of new hires by Oct. 1 of this year.

According to the Federal Register, the FDA raised rates for abbreviated new drug applications, the applications companies submit when filing for new generic product approvals; prior approval supplements to approved ANDAs; drug master files; generic drug active pharmaceutical ingredients; and finished dosage form facility user fees. The ANDA fee will be $63,860, compared with $5l,520 this year, an increase of 24%. The prior-approval supplement fee also will be raised by 24%, to $31,930. The domestic finished dosage form facility fee will be increased by 25%, to $220,152, and the drug master file fee will increase by 48%, to $31,460. Meanwhile, the active pharmaceutical ingredient fee will be set at $34,515. For foreign finished dosage form and active pharmaceutical ingredient facilities, the fees will be $235,152 and $49,515, respectively. The new rates become effective Oct. 1, 2013, and remain in effect through Sept. 30, 2014.

The new rates were issued amid news that the program has raised more than a quarter of a billion dollars in its first year. In a memo sent in June to staff members of the FDA’s Center for Drug Evaluation and Research, CDER director Janet Woodcock wrote that the agency had collected more than $255 million under GDUFA, and that it intends to collect $299 million in fiscal year 2013. During that time, it hired 165 new CDER staff members, helped to make it easier to accurately calculate fees and made "significant strides" in reducing the backlog of generic drug approval applications. Woodcock wrote that the program would transition to a new project and governance structure similar to PDUFA, led by a steering committee and focused on enhancing the program and transforming the review process. The committee includes people from CDER, the Office of Regulatory Affairs and FDA commissioner Margaret Hamburg’s office.

But the process has not necessarily gone smoothly. In March, FDA Office of Generic Drugs director Greg Geba resigned over differences related to a reorganization of the office. In his letter, he wrote that the office had issued nearly 600 complete response letters—which the FDA issues when it has finished reviewing an application but is unable to approve it in its present form—since the Oct. 1, 2012, implementation of GDUFA. The Generic Pharmaceutical Association, an industry trade group, expressed concern at the time that Geba’s departure would lead to "further disruption" at the OGD in the wake of the office lacking a leader between 2010 And 2012.

"As of July, the agency said it had reviewed more than 30% of the back-logged applications and streamlined the hiring process to recruit new staff."

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Biosimilars score a win

BY Alaric DeArment

The country’s embryonic biosimilars industry scored a victory last month as the organization that runs the pension fund for California state employees announced its opposition to a state Senate bill provision that would impose special requirements on pharmacists who dispense follow-on biologics.

Last month, the board of the California Public Employees’ Retirement System, also known as CalPERS, voted to oppose a provision in Senate Bill 598 that would require pharmacists to notify prescribers and patients if they have substituted a biosimilar, and also forbid them to substitute biosimilars if prescribers indicate "Do not substitute" on prescriptions. However, the bill contains a sunset clause and only applies to prescriptions made before 2017; at press time, both houses of the state legislature had passed it, and it was awaiting reconciliation and a signature or veto by Gov. Jerry Brown.

The provision, sponsored by Amgen and Genentech, is similar to legislation that has popped up in several states around the country as the Food and Drug Administration works on regulations on biosimilars, as mandated by amendments to the Patient Protection and Affordable Care Act of 2010. The Illinois state legislature defeated a similar bill in June, while Virginia Gov. Bob McDonnell signed that state’s bill into law in March.

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