Articles by Anna Rose Welch
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How To Make The Most Of Your FDA Biosimilar Meetings
11/14/2016
The FDA's John Jenkins shares several reasons why biosimilar makers shouldn't let their eagerness to get to market drive their development program.
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How These Biosimilar Unknowns Could Impact Manufacturers
11/10/2016
During my time covering biosimilars, I’ve grown well-versed in some of these arguments, including those around naming, labeling, and reimbursement. But several discussions in the past few months have added new layers of complexity to these issues.
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3 Big Biosimilar Questions At DIA 2016
11/2/2016
So far this year, I've attended three biosimilar conferences, the most recent being DIA Biosimilars 2016. While all three events touched on the broad (and often political) biosimilar challenges, including reimbursement, naming, interchangeability, and patient access, DIA offered a special glimpse into the more nitty-gritty challenges of biosimilar development.
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FDA Emphasizes Regulatory Flexibility In Biosimilar Reviews
9/28/2016
A study recently published in the BJCP go a long way toward providing a clear example of what regulatory flexibility looks like in the EMA. But where does the FDA, which got a late start with biosimilars, stand in terms of regulatory flexibility today?
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3 Lessons From The GPhA Biosimilars Council Conference
9/14/2016
This inaugural conference touched upon many of the topics one would expect, including reimbursement, interchangeability, naming, the global markets, and IP challenges. But I felt three overarching topics were particularly worthy of being singled out.
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Tips For Efficient Comparator Sourcing In Biosimilar Clinical Trials
8/26/2016
There is a lot of pressure for companies to accelerate the clinical development of a biosimilar to make it to market before it becomes overcrowded. One challenge facing companies is comparator sourcing for their Phase 1 and Phase 3 trials. As one expert outlines, there are two different strategies, each presenting drugmakers with different benefits and challenges.
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Best Practices For Maintaining A Blind In Biosimilar Clinical Trials
8/19/2016
A more aggressive clinical timeline for biosimilars can get a candidate to market more quickly. But it also becomes more difficult to ensure that clinical trial personnel running biosimilar trials clearly understand their roles and responsibilities, especially when it comes to maintaining a blind. There are several things for sponsors to consider in order to ensure the right people in the trial remain blinded.
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How “Consumer Reports” FDA Approvals Could Hurt Biosimilars
7/21/2016
A recently published article in The Wall Street Journal proposes several changes to the FDA approval process. However, at a time when there should be more emphasis on accelerating biosimilar approval, this proposal very well could spell trouble for biosimilars.
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Are Emerging U.S. Biosimilar Policies At Risk Of Alienating Physicians?
4/5/2016
Educating physicians is a prime goal in the U.S. in order to ensure biosimilars are prescribed. However, are the U.S.'s emerging biosimilar policies already at risk of alienating physicians?
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What Does FDA’s Biosimilar Workload Reveal About Emerging U.S. Market?
3/21/2016
The FDA has faced questions and criticism over its slow progress with biosimilar-related policies. In the face of these questions, however, the FDA has not provided any estimates or figures about the size of the biosimilars review team or the team's workload. Now, a new review released by ERG breaks down the agency's workload volume and costs, giving clearer insights into how the U.S. regulatory landscape is unfolding.