FDA Law Blog: Biosimilars
JANUARY 9, 2025
Although FDA has long taken the position that it has broad authority in how it conducts its inspections, it was not until 2012 that Congress put some teeth behind FDAs policy position. Using publicly available examples, these lessons will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection.
FDA Law Blog: Biosimilars
MAY 19, 2025
The government complaint, filed January 16, 2025, and amended April 18th, alleged that Walgreens pharmacies knowingly filled millions of unlawful controlled substance prescriptions between August 2012 and March 2023 despite clear red flags indicating a high likelihood that the prescriptions were invalid because they lacked a legitimate medical purpose (..)
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Agency IQ
AUGUST 25, 2023
New FDA guidance on interchangeable biosimilar labeling heads to White House for review The FDA has submitted a draft guidance focused on the labeling of interchangeable biosimilar products to the White House for review, which would fulfill a Biosimilar User Fee Act (BsUFA III)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.
The Pharma Data
JUNE 2, 2022
BYOOVIZ™ is the first FDA approved ophthalmology biosimilar BYOOVIZ, priced 40% lower than LUCENTIS®, provides an equally effective and more affordable treatment option to patients suffering from retinal disorders BYOOVIZ will be commercially available through major distributors across the U.S. on July 1, 2022. Biogen Inc.
The Pharma Data
JANUARY 24, 2021
Established in 2012, Samsung Bioepis has rapidly grown to have five biologic products in immunology and oncology with more than 215,000 patients treated with the company’s immunology products in Europe alone. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone.
FDA Law Blog: Biosimilars
NOVEMBER 27, 2023
According to the government, these companies knew as early as 2012 that their dehumidifiers were defective, in that they could overheat and catch fire. (the “Gree Companies”), an appliance manufacturer and two of its subsidiaries that were involved in the manufacturing, marketing, and sale of dehumidifiers.
FDA Law Blog: Biosimilars
MAY 13, 2024
Based on a review of premarket submissions made in 2012 through 2019, FDA identified 90 examples of 510(k)s, De Novos, HDEs, and PMAs approved/cleared which utilized RWE in support of regulatory decision-making. During this period the estimated total number of such submissions was approximately 26,121.
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