FDA Law Blog: Biosimilars

AUGUST 21, 2023

Attorney’s Office for the Western District of Texas announced that People’s Rx, a local chain operating five retail pharmacies and a compounding laboratory in the Austin area, agreed to pay $200,000 to settle allegations that it violated the Controlled Substances Act (“CSA”). By Larry K. Houck — Last week the U.S. 21 U.S.C. §

Controlled Substances 52

Controlled Substances General Merchandise Stores Grocery Stores Compounding 52

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.

Drug Development 103

Drug Development Biosimilars Documentation Labelling 103

Pharmaceutical Technology

JULY 23, 2008

It has boosted anti-tumour research by 60% since 2005, at a cost of $1.6bn, in the hope of increasing the share of company sales attributed to cancer drugs from the current level of 5% “There are a lot of patients that are suffering,” said Pfizer chief executive Jeffrey Kindler.

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Compounding Biosimilars 40

Express Pharma

JULY 10, 2024

Sasmitha Sahu, Managing Consultant, GlobalData states, “While India has demonstrated success in generic drug production, the same is not true for novel and biosimilar biopharma products.” ” According to Dr Anand, our IP framework has been getting streamlined since 2005.

Vaccines 96

Vaccines Drug Development Process Improvement Biosimilars 96