FDA Law Blog: Biosimilars

APRIL 8, 2025

Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Under GDUFA III alone, DPD published 32 GDUFA guidance documents and MAPPs to ensure the successful implementation of GDUFA.

Documentation 142

Documentation Labelling Drug Development 142

Express Pharma

MARCH 16, 2025

To move from generics to novel drug development, Indian companies must invest heavily in R&D for innovative therapies like biosimilars, cell and gene therapies, and specialty drugs. Similarly, Dr. Reddy’s and Cipla are exploring the biosimilar and complex generics space, focusing on areas like respiratory and oncology drugs.

Biosimilars 110

Biosimilars Insurance Coverage and Processing Pharmaceutical Companies Pharmaceutical Companies 110

Safe Biologics

FEBRUARY 1, 2024

The CHMP recognizes that there may be the potential to waive certain clinical data requirements even for complex biosimilars such as mAbs based on solid evidence of quality comparability. Comments may be submitted here until April 30, 2024.

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Biosimilars Documentation Drug Pricing 130

pharmaphorum

SEPTEMBER 16, 2021

Since their inception in 2013, Clinical Commissioning Groups (CCGs) have led medicines optimisation efforts at local level. Promoting automatic substitution of, for example, biosimilars on formularies and registers could accelerate conversion to use of biosimilars, releasing significant financial savings. Harnessing technology.

Biosimilars 113

Biosimilars Community Pharmacies Medical Records Documentation 113

FDA Law Blog: Biosimilars

MARCH 27, 2023

The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA. FDA has been implementing the UDI system with different compliance dates for different types of medical devices to ensure a smooth implementation. Most of the compliance dates have been passed.

Labelling 45

Labelling Packaging Documentation 45

FDA Law Blog: Biosimilars

DECEMBER 1, 2024

FDA reports that it told the company that “failure to allow photography would be documented as a refusal,” and the company “acknowledged the refusal.” To be clear, as we discussed in a blogpost back in 2013 , the Federal Food, Drug, and Cosmetic Act does not explicitly require companies to permit photographs to be taken.

Documentation 113

Documentation Labelling 113

pharmaphorum

JULY 8, 2022

” The document says that AbbVie booked 99% of its 2020 prescription drug sales income through its foreign subsidiaries, when 75% of it was made in the US. Now, it’s turning its attention to other big pharma groups, including Abbott Laboratories, Merck & Co and reportedly also Bristol-Myers Squibb.

Biosimilars 59

Biosimilars Documentation 59