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NEW: The 2022–23 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

Drug Channels

I am pleased to announce our new 2022–23 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. Drug Distribution Industry Expands as COVID-19 Disruption Fades and Biosimilars Boom (press release) We’re offering special discounted pricing if you order before October 21, 2022!

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FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications

FDA Law Blog: Biosimilars

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

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OPQ’s 2022 Report Shows the Global Task of Ensuring Quality

FDA Law Blog: Biosimilars

Consistent with that initiative, OPQ recently issued its 2022 Annual Report on the State of Pharmaceutical Quality. Here’s a breakdown of some of the more interesting highlights, statistics and graphics from the FY 2022 report. Recalls Recalls hit a five-year peak in 2022. The PHE also had a dramatic effect on import alerts.

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Analysis Life Sciences Thank You Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach

Agency IQ

Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products. regarding its administration, preparation, storage, or safety).

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Would I FIE to You? FDA’s First Interchangeable Exclusivity Determination Results in Expiration

FDA Law Blog: Biosimilars

The FIE determination released in fall 2023 involves the Reference Product AbbVie’s Humira (adalimumab) and two interchangeable biosimilars—first approved is Cyltezo (adalimumab-adbm), filed by Boehringer Ingelheim Pharmaceuticals, Inc, which was followed by Abrilada (adalimumab-afzb), filed by Pfizer.

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Available for Preorder: The 2023 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

Drug Channels

addresses the Inflation Reduction Act of 2022. There are 241 exhibits in the 2023 edition, compared with 216 in the 2022 edition. If you have any questions before purchasing a license to the report, please email me. A new Section 12.5. In Subsection 12.5.1., In Subsection 12.5.2., Copyright © 2006-2023 Pembroke Consulting, Inc.

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Article FDA Thank You New FDA guidance on interchangeable biosimilar labeling heads to White House for review

Agency IQ

New FDA guidance on interchangeable biosimilar labeling heads to White House for review The FDA has submitted a draft guidance focused on the labeling of interchangeable biosimilar products to the White House for review, which would fulfill a Biosimilar User Fee Act (BsUFA III) commitment.