Biosimilars

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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29
Sep

AAM Releases Its 2020 Savings Report

The Association for Accessible Medicines released its 2020 Generic Drugs and Biosimilars Access and Savings in the U.S. Report (here) yesterday, outlining the savings that these products brought to American consumers in 2019. “In 2019, according to data provided by IQVIA, U.S. savings from generic drugs added up to $313 billion—including $96 billion and $48.5 […]

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14
Sep

Lachman OnCall™ GMP Teleconsulting – When you can’t wait to get going.

When you can’t wait for answers to your GMP questions, it’s time for Lachman OnCall™. Our Subject Matter Experts (SMEs) understand you need advice right away. Lachman’s SMEs have the knowledge, experience, and skills to address your most urgent scientific, technology, and compliance-related questions, such as: “We had to shut down our sterile manufacturing plant […]

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