Pharmaceutical Technology
OCTOBER 28, 2022
Practising QbD in biosimilar product development. One area in which QbD should be practised is that of biosimilars, also known as follow-on biologics or subsequent entry biologics. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.
pharmaphorum
FEBRUARY 1, 2021
A push for biosimilars. 2021 will see simplified requirements for biosimilars being implemented. Companies can let AIFA know about biosimilars coming to market giving 30 days notice from the end of the originator patent. Lower paybacks possible. The Italian industry makes regular paybacks when spending ceilings are breached.
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FDA Law Blog: Biosimilars
APRIL 8, 2024
It also noted that last year, FDA hosted a two-day public workshop and published a white paper on the regulatory framework for Artificial Intelligence in drug manufacturing, in addition to other efforts. Like many of us, OPQ seems intent on trying to keep up with how technology can/will impact pharmaceutical quality.
pharmaphorum
JUNE 29, 2022
Sarah presents to hundreds of pharmaceutical industry clients every year on a range of global pharmaceutical industry issues, publishing white papers on many topics, including: uptake and impact of innovative medicines, and challenges for Launch Excellence. the impact of the pandemic on medicines markets and Rx launch.
FDA Law Blog: Biosimilars
APRIL 8, 2024
Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response. By Kalie E.
pharmaphorum
JANUARY 14, 2021
As interactive time with HCPs is likely to be scarce, companies need to be even more ruthless in prioritising content and in deciding what content to generate in the first instance – for example, in Real World Evidence, as outlined in IQVIA’s white paper, ‘Excellent Launches are winning the Evidence battle’ CNS (re) emerges.
FDA Law Blog: Biosimilars
JUNE 19, 2023
See , e.g. , ACLA White Paper on LDTs here. Given the make-up of the House and the aversion to expansion of FDA authority, it seems extremely unlikely that the newest version of the VALID Act, which was introduced in March 2023, will advance in the next two years.
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