GPhA pledges support behind Affordable Medicines Caucus
WASHINGTON — The Generic Pharmaceutical Association on Friday applauded the launch of the bipartisan Affordable Medicines Caucus, co-chaired by Reps. Peter Welch, D-Vt., and Keith Rothfus, R-Pa.
“Members of both parties agree: taking full advantage of generic medicines is a common sense way to save billions of dollars for the government, and for millions of Americans,” stated Ralph Neas, president and CEO GPhA. “Indeed, an IMS health analysis released by GPhA in December 2013 showed that generic pharmaceuticals have achieved $1.2 trillion in savings over the past decade, nearly $217 billion in 2012 alone, all of which translates to more than one billion dollars in savings every other day.”
The caucus will share the latest information on the positive impact of generics on cost savings and help legislators track the latest developments in the field. “Working together,” Neas said, “we can build on the tremendous 30-year track record of bipartisan cooperation that has resulted in unprecedented access to safe, affordable and life-changing generic medicines in America and around the world.”
Sandoz reports on six biosimilar molecules in the Phase III clinical trial/filing prep phase
BASEL, Switzerland — Sandoz recently announced that the generic manufacturer continues to advance its biosimilars pipeline that currently has six molecules in the Phase III clinical trial/filing prep phase.
For example, Sandoz completed the patient enrollment for its Phase III trial with biosimilar etanercept (Amgen’s Enbrel). The global clinical trial seeks to confirm biosimilarity with regard to safety, efficacy and immunogenicity of the Sandoz product versus Enbrel in patients with moderate to severe chronic plaque-type psoriasis.
Sandoz also completed a Phase III trial for the U.S. registration of biosimilar filgrastim (Amgen’s Neupogen) and two global Phase III trials for global registration of biosimilar pegfilgrastim (Amgen’s Neulasta). The trials aimed to confirm biosimilarity of the Sandoz biosimilars versus Neupogen and Neulasta in breast cancer patients eligible for myelosuppresive chemotherapy treatment. Sandoz is currently preparing to file Filgrastim in the United States, and pegfilgrastim in the United States and Europe.
Sandoz also continues to make strong progress on its other biosimilar clinical development programs, which includes biosimilar versions of rituximab (Roche’s Rituxan/MabThera) and adalimumab (AbbVie’s Humira).
Government report provides the science behind extended allergy season
WASHINGTON — The Obama Administration on Tuesday unveiled the Third U.S. National Climate Assessment, a scientific report about climate changes that are happening now in the United States and how they are impacting the nation’s health, with longer allergy seasons, for example.
"Climate change, as well as increased CO2 by itself, can contribute to increased production of plant-based allergens," the report noted. "Higher pollen concentrations and longer pollen seasons increase allergic sensitizations and asthma episodes, and diminish productive work and school days. Simultaneous exposure to toxic air pollutants can worsen allergic responses. Extreme rainfall and rising temperatures also can foster indoor air quality problems, including the growth of indoor fungi and molds, with increases in respiratory and asthma-related conditions."
Ragweed pollen season length has increased in central North America between 1995 and 2011 by as much as 11 to 27 days in parts of the United States and Canada in response to rising temperatures, the report suggested. Increases in the length of this allergenic pollen season are correlated with increases in the number of days before the first frost. The largest increases have been observed in northern cities. In 2012, a warm winter leading to early pollen production among trees and plants, followed by hot, dry, low-humidity conditions through the spring and summer contributed to wide circulation of aeroallergens and a severe allergy season, according to reports from physicians.