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). BMB Reports.

Drug Development 103

Drug Development Biosimilars Documentation Labelling 103

FDA Law Blog: Biosimilars

JUNE 11, 2023

Clissold — In May 2023, CDER and CBER published a draft guidance titled “Pediatric Drug Development: Regulatory Considerations – Complying with the Pediatric Research Equity Act [“PREA”] and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act [“BPCA”]” (the “Draft Guidance”).

Labelling 40

Labelling Drug Development 40

European Pharmaceutical Review

OCTOBER 19, 2022

1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment. Biopharmaceutical Research & Development: The Process Behind New Medicines. 2022;12(7):3049-3062.

Biosimilars 96

Biosimilars Dosage Drug Pricing Pharmaceutical Companies 96

Pharmaceutical Technology

OCTOBER 28, 2022

Quality by design (QbD) is a concept introduced into the pharmaceutical regulatory lexicon in 2005. It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Practising QbD in biosimilar product development.

Biosimilars 52

Biosimilars Vaccines Drug Development Documentation 52

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