RX Note

DECEMBER 25, 2024

However, with the proliferation of biosimilars and liposomal or pegylated forms, health care professionals are now encouraged to communicate using product name for certain circumstances (e.g. bioavailability differences, release profile variations, biologics and biosimilars , licence variations and patient factors) to avoid confusion.

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Pharmaceutical Technology

OCTOBER 28, 2022

Quality by design (QbD) is a concept introduced into the pharmaceutical regulatory lexicon in 2005. 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.

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European Pharmaceutical Review

OCTOBER 19, 2022

2 Recently, the US Patent and Trademark Office (US PTO) reiterated the concern that patents have been “misused to inhibit and delay – for years and even decades – competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.” Patents are often described as the ‘lifeblood’ of pharmaceutical companies.

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pharmaphorum

JANUARY 27, 2023

About the author Richard Saynor was appointed CEO of Sandoz in 2019, a Novartis generics and biosimilars division. He previously held regional leadership roles at Sandoz between 2005 and 2010. Saynor has a wealth of experience in the pharmaceutical industry, including at both innovation-driven companies and generics makers.

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FDA Law Blog: Biosimilars

SEPTEMBER 26, 2023

Since I entered the life sciences industry in 2005, I’ve respected HP&M and admired their expertise and elite standing,” said Grizzel. “I Ellison, HP&M’s Managing Director. I’m incredibly excited by the opportunity to work for HP&M and its amazing group of professionals.

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FDA Law Blog: Biosimilars

AUGUST 21, 2023

Investigators also found that the pharmacy sold pseudoephedrine (“PSE”) products but failed to self-certify in violation of the Combat Methamphetamine Act of 2005 (“CMEA”). We note that in December 2020, the same U.S. 2, 2020 ( DOJ Press Release ). 21 U.S.C. § 830(e)(1)(B)(i).

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European Pharmaceutical Review

JULY 4, 2024

4,6 Five patent issues that European biosimilar developers should consider before entering the US market Quality control of the botanical drug substances was one of the critical factors that led to barricades during the development of Veregen and Mytesi. 2005 [cited 2024May]. 2012/1916). Available from: [link] Barber S.

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