2026 Biosimilars Labelling 
Big Molecule Watch
DECEMBER 28, 2023
Below is a recap of the top M&A deals in 2023 that focus on biologics and biosimilars and were covered on the Big Molecule Watch. Reddy’s”) to license Dr. Reddy’s proposed biosimilar abatacept for the development and commercialization of COYA 302 for the treatment of neurodegenerative conditions. Reddy’s Laboratories Ltd. (“Dr.
FDA Law Blog: Biosimilars
DECEMBER 3, 2023
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. The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug.
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Big Molecule Watch
JANUARY 10, 2025
As 2025 begins, we would like to reflect on last years regulatory developments in the biologics and biosimilars space. There were also 18 FDA approvals of biosimilar products , including 6 ustekinumab biosimilars and 5 aflibercept biosimilars in 2024 alone. These new prices will take effect starting January 1, 2026.
Putting Patients First Blog
JANUARY 27, 2025
3 ,4, 5 As such, the NHC supports CMS proposal to ensure that Part D sponsors cover AOMs for obesity with clinical criteria that is not more restrictive than the FDA labeling for each AOM. Increased transparency will ensure that formulary practices align with broader goals of affordability and patient access.
FDA Law Blog: Biosimilars
FEBRUARY 21, 2024
This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”
Pharmaceutical Technology
JANUARY 10, 2023
Type 2 diabetes (T2D) is a crowded and competitive landscape with multiple “me-too,” generic and biosimilar drugs entering the market, with market growth primarily driven by an increasing prevalent population across nine major markets (9MM: US, France, Germany, Italy, Spain, UK, Japan, China, and India).
FDA Law Blog: Biosimilars
JULY 7, 2024
10] Performance specifications “include all claims made in the labeling for the device,” and “the intended performance of a device refers to the intended use for which the device is labeled or marketed.” [11] With respect to the UDI requirement, FDA regulations require them to be placed on the device “label.”
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