The question of interchangeability for biosimilars has haunted the US Food and Drug Administration since the promulgation of the Biologics Price Competition and Innovation Act of 2010. The FDA’s draft guidelines on interchangeability evolved very slowly, and the biosimilar industry had to work to (1) keep up with the guidelines as they gained clarity, (2) … Continue reading Biosimilar-to-Biosimilar Switching: The Data Say Its Fine
Tag: interchangeability
Insulin Transitions: A Dead Zone in the Gap Year, and Other Considerations
An Assessment With Gillian Woollett, MA, DPhil, Senior Vice President, Avalere Health In this two-part conversation with one of the real go-to experts in the biosimilar field and US regulatory process, we talk with Dr. Woollett about the upcoming transition for insulins and other pharmaceuticals in March 2020, when they become regulated as 351(k) biosimilars. … Continue reading Insulin Transitions: A Dead Zone in the Gap Year, and Other Considerations
A Payer’s Preference for Biosimilars, Interchangeability, and Incentivizing Providers to Use Biosimilars
In the last few weeks, we’ve seen a hail of biosimilars-related news, some of which significant, more having limited impact. Building upon the success of its infliximab biosimilar uptake, Magellan Rx Management announced June 4 that it will extend its medical pharmacy program to the new oncology biosimilars (i.e., rituximab, trastuzumab, and bevacizumab) when launched. … Continue reading A Payer’s Preference for Biosimilars, Interchangeability, and Incentivizing Providers to Use Biosimilars
When Biosimilars Are Switched for Each Other
In April, the Center for Biosimilars reported on a study of infliximab switching in patients with psoriasis. The researchers found no differences in safety or effectiveness in 24 patients taking infliximab biosimilars. I had to read the copy twice; it took me a couple of moments to understand the significance of this small study. Beyond … Continue reading When Biosimilars Are Switched for Each Other
Boehringer Ingelheim Gives up the Fight, Signs AbbVie Agreement on Adalimumab
It seems that AbbVie has won the battle and the war. The last remaining holdout in the fight to bring a biosimilar adalimumab to market before 2023 has capitulated, as AbbVie announced May 14 that Boehringer Ingelheim agreed to the terms of a licensing arrangement. This agreement allows Boehringer Ingelheim to enter the marketplace July … Continue reading Boehringer Ingelheim Gives up the Fight, Signs AbbVie Agreement on Adalimumab
Federal Policy and Biosimilars: A Conversation With Molly Burich, MS, Boehringer Ingelheim: Part 2
In part two and the conclusion of this interview, Molly Burich, MS, Director, Public Policy: Biosimilars and Pipeline, speaks to Boehringer Ingelheim's progress in Cytelzo interchangeability studies, its plans for the product in Europe in the face of several adalimumab biosimilars launches in the EU, and also the complexity inherent in CMS's plans to move biologic … Continue reading Federal Policy and Biosimilars: A Conversation With Molly Burich, MS, Boehringer Ingelheim: Part 2
Word From the Adalimumab Front: A Conversation With Molly Burich, MS, Boehringer Ingelheim: Part 1
In the first portion of a two-part interview with Molly Burich, MS, Director, Public Policy: Biosimilars and Pipeline, Boehringer Ingelheim, we cover the challenges of driving biosimilar uptake, as well as the unique situation that has focused this manufacturer's attention on biosimilars and interchangeability. BR&R: The viability of the US biosimilar industry is being challenged if … Continue reading Word From the Adalimumab Front: A Conversation With Molly Burich, MS, Boehringer Ingelheim: Part 1
More From GRx+Biosims on Four-Letter Suffixes and Biosimilar Interchangeability
The talk at the GRx+Biosims 2018 meeting this month in Baltimore was about challenges, but extrapolation was not one of them. Biosimilar interchangeability was. That was not entirely surprising. In market research projects I’ve been involved with over the past year, payers and physicians in medical groups have broadly indicated that they’ve gotten past the … Continue reading More From GRx+Biosims on Four-Letter Suffixes and Biosimilar Interchangeability
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: One Challenge With no Easy Solution
Food and Drug Administration Commissioner Scott Gottlieb, MD, undoubtedly understands the threat to a successful biosimilar industry in the US, and his well-reported remarks emphasize some of the key issues. The policies that the FDA Commissioner wants to bring to bear on the multifaceted problem may be harder to implement. In this post, we examine … Continue reading Analyzing FDA Chief Gottlieb’s Remarks: One Challenge With no Easy Solution