PHARMACY

AAM, 28 groups oppose barriers to generics, biosimilar access in USMCA

BY Sandra Levy

The Association for Accessible Medicines has joined 28 groups representing patients, taxpayers, workers and healthcare groups in submitting letters to U.S.Trade Rep. Robert Lighthizer, Health and Human Services Secretary Alex Azar, and congressional leadership, expressing concern that the U.S.-Mexico-Canada Agreement, or USMCA, if left in its current form, will keep drug prices high and out of reach of Americans.

Citing the results of a recent survey, AAM said Americans do not want the new USMCA to raise drug prices or decrease competition from more affordable generic or biosimilar medicines. The survey found that 84% of respondents said they believe trade policy should lower — not increase — drug prices; 81% believe trade policy should increase access to affordable medicine; and nearly three out of four voters from across the political spectrum are concerned that the USMCA would negatively impact drug prices, delay patient access to more affordable generic and biosimilar medicine, and impose new barriers to the development of lower-cost medicine.

AAM created medsforamerica.org to provide information for consumers about the new trade agreement, and how USMCA would hurt patient access. The site provides an easy way to contact one’s member of Congress in just one click. The #FixUSMCA campaign, launched on Monday, already has generated more than 2,000 page views, and people have sent over 1,000 messages to Congress, according to the AAM.

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PHARMACY

Lupin receives FDA blessing for generic Pulmicort

BY Sandra Levy

Lupin has received the Food and Drug Administration’s clearance for budesonide inhalation suspension 0.5 mg/2 mL single-dose ampules.

The product is the generic version of AstraZeneca’s Pulmicort respules inhalation suspension 0.5 mg/2 mL. It is indicated for the maintenance treatment of asthma and as prophylactic therapy in children age 12 months old to 8 years old.

Budesonide inhalation suspension 0.5 mg/2 mL single-dose ampules had a market value of approximately $474.5 million, according to September 2018 IQVIA data.

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Xellia rolls out vancomycin

BY Sandra Levy

Xellia Pharmaceuticals, a manufacturer of specialty anti-infective treatments, is launching vancomycin hydrochloride for injection.

Vancomycin injection is used to treat infections in many different parts of the body.

“As a leading global supplier of vancomycin API, we are excited to now offer vancomycin 1 g and 10 g in the United States from our vertically integrated supply chain and significant injectable manufacturing footprint,” Xellia North America president Craig Boyd said. “This is the first of many key launches that will bring Xellia’s strong portfolio of established and innovative products to patients in need of critical anti-infective treatments.”

The product had a market value of $338 million for the 12 months ending August 2018, according to IQVIA.

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