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First Biosimilar Application Arrives At FDA -- Sandoz's Filgrastim -- With Key Policy Issues On Tap

FDA accepted Sandoz's application for a biosimilar version of filgrastim, the company said Thursday (July 24), touting the first application in the highly watched biosimilar pathway created by the Affordable Care Act.

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The National Association of Medicaid Directors sent CMS initial recommendations for revamping Medicaid managed care regulations after hearing informally that the agency hopes to update rules that have been in place since the 1990s, with a key proposal that CMS move away from requiring waivers for any changes states make to Medicaid managed care programs.

CMS says in the coming weeks it will begin terminating coverage or adjusting subsidies for exchange enrollees who have failed to provide supporting documents that were requested to resolve inconsistencies with the information they provided on applications, but the agency has yet to disclose an exact timeline or the number of people that could be affected.

The U.S. Court of Appeals for the Second Circuit Thursday (July 24) said any decision to institute or terminate a hearing process that could lead to withdrawing the approval of animal antibiotics should be left up to FDA.

A small-town Republican mayor from rural North Carolina claiming his GOP-led state's refusal to expand Medicaid under the Affordable Care Act has led to a hospital closure and a death in his community may be the new face of the fight for expansion in the 24 states that have resisted opening their programs to provide health care for low-income families and individuals who earn up to 133 percent of the federal poverty level, key sources say.

Gilead announced Wednesday (July 23) that it sold $3.48 billion of its breakthrough hepatitis C drug Sovaldi in the second quarter of this year, beating Wall Street expectations, and the company is on track to generate between $21 billion and $23 billion in sales from all its drugs this year -- prompting health plans and the National Coalition on Health Care to decry the $84,000-per-course cost of Sovaldi and demand Gilead lower the price.

Sovaldi-maker Gilead hasn't complied with a request from House Democrats to justify the $84,000-per-course treatment of the hepatitis C drug, Energy & Commerce Ranking Democrat Henry Waxman (CA) said Wednesday, but a Gilead official said the company is complying with a similar request for information from the Senate Finance Committee.

Alleged misuse of Risk Evaluation and Mitigation Strategies have delayed market entry for 40 small molecule generic drugs, causing $5.4 billion in annual lost savings for public and private payors, according to a recent study conducted by Matrix Global Advisors and backed by the Generic Pharmaceutical Association.

HHS announced the hiring of a new senior counselor on Wednesday (July 23) who will report directly to HHS Secretary Sylvia Mathews Burwell and “work very closely with HHS and the CMS leadership to help ensure the success of the second open enrollment period.”