The year 2020 has gotten off to a flying start—probably a direct consequence of 2019 finishing with a flurry. One of the first eye-catching bits of news was the request by several states for the Supreme Court to intervene now, not later, in the case that threatens the fundamental basis on which the biosimilar pathway … Continue reading Will the Supreme Court Fast Forward Health Insurance Reform in 2020?
Tag: BPCIA
New Biosimilar Guidances From the FDA Announced by Commissioner Gottlieb
On December 11, the Commissioner of the Food and Drug Administration (FDA), Scott Gottlieb, MD, issued a far-ranging statement on actions to be taken by the federal government to improve access to biosimilars and to begin the transition of insulins, growth hormones, and other selected drugs to biologic status, under section 351 of the Public Health … Continue reading New Biosimilar Guidances From the FDA Announced by Commissioner Gottlieb
State Biosimilar Laws Need Clarity and Consistency
Although 41 states currently have passed legislation to enable plans to substitute interchangeable biosimilars, these state biosimilar laws seem an attempt to put the cart in front of the horse. Reginia Benjamin, JD, Director of Legislative Affairs, at the Academy of Managed Care Pharmacy, explained that the first state legislation to optimize the use of … Continue reading State Biosimilar Laws Need Clarity and Consistency
Analyzing FDA Chief Gottlieb’s Remarks—Part 2: FDA and Marketing Exclusivity
Food and Drug Administration Chief Scott Gottlieb, MD, received a great deal of coverage for his recent remarks on providing better access to biosimilars. He seems intent on finding solutions to the underlying problems in delayed biosimilar launches. He discussed in the interview with CNBC perhaps the most intractable problem: The US biosimilar industry has … Continue reading Analyzing FDA Chief Gottlieb’s Remarks—Part 2: FDA and Marketing Exclusivity
The Week in Biosimilar News
You know it’s been a pretty desperate week in the biosimilar blogosphere when twitter feeds relate back to articles published in January, rehashes of the US Supreme Court decision in June, or yet another estimate of the savings potentially ascribed to biosimilar use (based on erroneous assumptions). However, there were a few significant tidbits announced last week that are worth reviewing.