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What to Expect When you are Expecting…a Government Shutdown

FDA Law Blog: Biosimilars

Lewis, , Principal Regulatory Device and Biologics Expert The FDA is currently funded through March 1st, 2025. For pre-license or pre-approval inspections, the outcome of a shutdown is less draconian as these are under the auspices of a user-fee program. By Richard A.

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Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

Agency IQ

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.

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Radical Transparency or Radical Redundancy? FDA Publishes 200+ Complete Response Letters, Most of Which Are Already Public

FDA Law Blog: Biosimilars

Butler — In a move FDA is calling “radical transparency,” the Agency announced on July 10, 2025 that it has published 200+ Complete Response Letters (CRLs) issued in response to marketing applications for drugs and biologics on its openFDA database. By Sarah Wicks & Michelle L.

FDA 52
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AbbVie Reports Full-Year and Fourth-Quarter 2020 Financial Results

The Pharma Data

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. percent on an operational basis, due to biosimilar competition. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent on a Reported Basis, or 12.5

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Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

The following PDUFA dates were obtained from publicly available sources.

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Article EMA Thank You MHRA introduces an expanded international recognition procedure, while planning to sunset the current EC reliance pathway

Agency IQ

The MHRA notes that the new pathway will be parallel to its innovation pathway (the Innovative Licensing and Access Pathway , or ILAP), which integrates “early regulatory advice with health technology assessment advice.” centralized procedure until 2025, when the Windsor Framework takes effect. market more quickly. reference product.

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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog: Biosimilars

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.