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i-Health offers chewable probiotic for adults

BY Michael Johnsen

CROMWELL, Conn. — Earlier this year, i-Health identified a niche need within the probiotic segment — an adult-strength chewable version of its probiotic brand, called Culturelle Digestive Health Probiotic Chewables, for those consumers in search of alternatives to the tablets and caplets.

The new product launch has contributed to an overall brand lift of 44.5% to $61.6 million in total U.S. multi-outlet sales for the 52 weeksended Aug. 11, according to IRI.

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Biosimilars market in Europe provides insights to U.S.

BY Alaric DeArment

When it comes to laws and regulations, what happens in Europe stays in Europe generally, and doesn’t have much bearing on the United States. But a recent win in Europe for U.S. drug maker Hospira could have some implications for the United States as well.

Last month, the company — which specializes in making generic injectable drugs — announced that European Union regulators had approved the continent’s first biosimilar monoclonal antibody.

Biosimilars have been on the market in Europe for several years now, but what’s significant about the approval of Hospira’s Inflectra (infliximab) — a biosimilar version of Merck’s and Johnson & Johnson’s Remicade — is that it marks a big move up the value chain. Monoclonal antibodies, so called because they are produced within genetically manipulated cells that are all clones and part of a single cell line, are considered more difficult to make than other biotech drugs, such as growth hormones and interferons.

The United States, of course, is far behind Europe in the maturity of its biosimilars market. The only biosimilar available here so far is Sandoz’ growth hormone treatment Omnitripe (somatropin [rDNA origin]), a biosimilar version of Pfizer’s Genotropin. That received Food and Drug Administration approval in 2006 under a special, one-off approval pathway. Other than that, the Patient Protection and Affordable Care Act of 2010 contained provisions for an abbreviated approval pathway for biosimilars, though the FDA still has to finish putting together regulations, a process that experts expect to take a few more years.

But regardless of regulatory differences between the United States and Europe, the ability to market biosimilars over there provides important experience for their future marketing over here. By the time the FDA is ready to start looking at abbreviated biologic license applications here, for example, Inflectra possibly will have been on the market in Europe for several years, thus providing significant amounts of clinical data, not to mention the many years’ worth of clinical data for biosimilars already on the market in Europe.

Another potential use of those clinical data is that they might quell some of the concerns about the safety and equivalency of biosimilars that have popped up in the United States lately.

In August, California’s state legislature passed SB 598, a bill that would limit the ability of pharmacists to substitute biosimilars for branded biologics — one of several such bills that have seen mixed fortunes in state legislatures around the country. But the Food and Drug Administration has criticized such bills, saying they undermine trust in biosimilars. According to published reports, an FDA spokeswoman said “efforts to undermine trust in these products” were cause for worry and did not serve patients’ interests.

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GDUFA tackles backlog of drug approval applications, FDA hires more staff

BY Alaric DeArment

For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.

When Congress approved a reauthorization of the Prescription Drug User Fee Act that included the Generic Drug User Fee Amendments last year, that backlog included about 2,500 applications. But thanks to GDUFA, the agency has managed to clear muchof it.

As of last month, more than 40% of the backlog applications had been reviewed, according to the FDA, which had collected more than $255 million in user fees to finance the program. Also last month, the agency announced that it exceeded its staff-hiring goals, having hired 234 new workers, three more than the 231 planned. In total, it hopes to hire 921 in a three-year push, including 461 people during fiscal year 2014.

“I am extremely happy with this accomplishment,” Center for Drug Evaluation and Research director Janet Woodcock wrote in a memo to FDA staffers. “As hiring continues through the end of this fiscal year, planning has already begun for next fiscal year.”

The Generic Pharmaceutical Association greeted the news with excitement. “Making these hiring decisions is an important step to achieve the goal of [the Generic Drug User Fee Amendments] and address the delays that reduce Americans’ access to affordable medicines,” GPhA president and CEO Ralph Neas said. “The FDA has a critical task at hand: reducing the backlog in applications for new generic medicines and speeding the average [abbreviated new drug application] approval time.”

For fiscal year 2014, the agency hopes to conduct post-market evaluation of generic drugs that will include research into surveillance and monitoring methods for them while gauging patients’ perceptions of generic drug quality and effectiveness. Other research will focus on the equivalence between generic inhaled, topical, dermatological, nasal, ophthalmic and other generic drugs and their branded counterparts, as well as research on abuse-deterrent systems for drugs prone to abuse, which would include opioid painkillers.

The FDA also is increasing generic drug user fees for the fiscal year. For example, the fee for filing an abbreviated new drug application, or ANDA, will be $63,860, compared with $51,520 for fiscal year 2013, a 24% increase.

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