PHARMACY

Calif. governor should veto biosimilar bill, GPhA’s Ralph Neas writes

BY Alaric DeArment

NEW YORK — A trade group of generic drug makers is hoping that California’s governor vetoes a bill that it says would restrict patients’ access to biosimilars.

In an op-ed published Friday in the San Jose, Calif., Mercury News, Generic Pharmaceutical Association president and CEO Ralph Neas wrote that the bill, S.B. 598, which the legislature passed last month, would cause the state to miss out on the more than $27.6 billion in savings over the next decade that pharmacy benefit manager Express Scripts estimates could be had if the state’s healthcare system had full access to biosimilars.

"Unless Gov. Jerry Brown vetoes a bill that would restrict future access to biosimilar medicines, Californians are at risk of becoming pawns in the self-serving efforts of large biotech companies to protect profits at the expense of patients," Neas wrote.

Click here to read the full letter.

 

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PHARMACY

New York Times analysis touts generic drugs

BY Alaric DeArment

NEW YORK — An analysis by the New York Times published over the weekend makes the case for generic drugs.

Times reporter Katie Thomas opened the analysis Saturday by recalling an episode of the Netflix series "Orange Is the New Black," in which the prison saves money by switching inmates to generic drugs, much to their dismay. But that bit of artistic license on the part of the show’s writers is evidence of the negative perceptions of generic drugs among the public.

Thomas noted that though generics are perceived as a greater value than their branded counterparts, patients mostly prefer the latter, according to some studies. But while Food and Drug Administration regulations require that generics be equivalent to and interchangeable with branded drugs — and by all accounts generic drug companies have followed those regulations — Thomas cited such issues as Ranbaxy Labs’ manufacturing problems and the equivalence issues with a dosage of a generic version of GlaxoSmithKline’s Wellbutrin (bupropion hydrochloride) as giving some people the idea that generics were inferior to branded drugs.

But those are isolated incidents, rather than evidence of a larger problem. Overall, as IMS Health data have shown over the years, generic drugs have saved the country’s healthcare system — and consumers — about $1 trillion over the past decade.

Click here to read Thomas’ analysis.

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Late-stage clinical data support experimental MS drug, say Teva, Active Biotech

BY Alaric DeArment

JERUSALEM — Late-stage clinical data support the efficacy of an experimental drug under development by Teva Pharmaceutical Industries and Active Biotech for multiple sclerosis, the two companies said.

At the 29th congress of the European Committee for Treatment and Research in Multiple Sclerosis in Copenhagen last week, Teva and Active presented phase-3 data from two studies that they said supported the hypothesis that oral administration of the drug laquinimod once per day may have an effect on inflammation and underlying mechanisms that result in progression of relapsing-remitting MS. Of the four types of MS, relapsing-remitting is the most common.

"Continued analysis of the Allegro and Bravo phase-3 studies demonstrates that the trend of efficacy results was maintained in the analysis of data pooled from the two studies and is consistent with the proposed mechanism of action for laquinimod," Teva president of global research and development and chief scientific officer Michael Hayden said. "Teva remains committed to the laquinimod clinical development program in MS and in other diseases characterized by a neurodegenerative pathology and to addressing the needs of these patients worldwide."

 

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