Though the interchangeability draft guidance seemed to be well-received by biosimilar makers, I’m hesitant to interpret the surprising post-guidance quietness to mean companies have no concerns about the bar it sets for attaining interchangeability.
I recently attended the IQPC Biosimilars Analytical Similarity, Clinical Studies, and Market Entry conference. This event, which took attendees into the heart of biosimilar development (the analytical and statistical work) was a great example of the scientific challenges developers may face while working with different regulatory agencies.
In the spirit of this list-making season, I compiled what I thought were the five most important biosimilar-related triumphs in the past year. Many of these events were widely covered by the media and will play an influential role in how the biosimilar industry unfolds through 2017 and beyond.
Relocating an organization as large as the EMA, which employs upwards of 1,000 people in London, will be no easy feat. As such, IDA Ireland, an agency that supports companies in Ireland and promotes foreign direct investments in the country, is working to compile information on why Ireland would be a good location for the EMA.
As the U.S. faces its first biosimilars for oncology, rheumatology, dermatology, and gastroenterology indications, a new publication from the Biosimilars Forum shows there’s quite a bit of work to be done to educate U.S. physicians.
The FDA's John Jenkins shares several reasons why biosimilar makers shouldn't let their eagerness to get to market drive their development program.
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.
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.
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?
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.