Biosimilars Payments In Medicare: CMS Signals Willingness To Change
Policy of paying for all biosimilars referencing the same drug at one blended rate is under review, to the relief of product developers and other stakeholders.
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US Biosimilars: 40% First-Cycle Approval Rate Leaves Room For Improvement
Four of first 10 publicly disclosed applications were approved on first review cycle, and FDA has issued at least seven complete response letters. Increasing first-cycle approvals is a primary goal of the BsUFA II agreement.
Samsung’s Renflexis: Second US Biosimilar To Janssen’s Remicade, With A Few Firsts
Infliximab-abda gains FDA licensure without having faced an advisory committee review; under current case law, launch could come as early as mid-October.
Doc Groups Seek To Block CMS Biosimilars Policy Via Congress
Letter from six physician organizations to Senate Finance Committee Chairman Hatch says CMS' decision to group multiple biosimilars into a single payment code undermines innovation, science and safety.