Biosimilars

16
Feb

Final Day at AAM Annual Meeting – “CEOs Unplugged” Highlights

The most popular program of each year’s AAM Annual Meeting is always the CEO unplugged session.  Oftentimes there are significant disagreements between the different CEOs regarding strategy, but this year there was almost complete agreement on strategic issues, policy, the marketplace, and regulatory issues.  The four panelists were Sven Dethlefs, Ph.D, Executive Vice President, North […]

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15
Feb
Key Points

Some Highlight Facts from the AAM Annual Meeting on Tuesday – Oh, and, By the Way, Robert Califf was Confirmed as FDA Commissioner Today!

(Not that we had anything to do with Califf’s confirmation but we are all glad that this is in the Agency’s rearview mirror and it now has a permanent rudder for the foreseeable future.) Anyway, the AAM annual meeting is in full swing and I thought that I would give a few bullet points of […]

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29
Jul
First

Big Day in the Biosimilar World – First Interchangeable Product Approved for Insulin!

Everyone knew this day would come and it has been a long time in coming.  Yesterday, the FDA approved the first interchangeable biosimilar for an insulin product.  An interchangeable biosimilar, like an AB-rated generic product, can be substituted at the pharmacy without intervention of the healthcare provider. According to the FDA announcement, “Semglee (insulin glargine-yfgn) […]

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17
Mar
Rough roadway

Update on Meeting CDER User Fee Goals During Pandemic – Not Too Bad!

As we all know, the pandemic has wreaked havoc with inspections of drug manufacturers, API manufacturers, and laboratory facilities, as well as inspection of clinical study sites.  Remote working, meeting problems, and just general pandemic fatigue has hindered some of the FDA’s work.  However, the statistics are not as bad as one might think, all […]

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20
Nov

New Draft FDA Guidance on BLAs for Biosimilars and Interchangeable Biologics

The FDA has just published a new draft Q&A Guidance document regarding BLA submissions for biosimilar products and interchangeable biosimilar products, as well as recommendations for labeling of interchangeable biosimilar products.  This guidance (Biosimilarity and Interchangeability: Additional Draft Q & As on Biosimilar Development and the BPCI Act is available here) and supplements the two […]

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