FDA Law Blog: Biosimilars

APRIL 8, 2025

OGDP is one of several offices in OGD, and it was composed of three divisions: the Division of Legal and Regulatory Support, the Division of Orange Book Publication and Regulatory Assessment, and the Division of Policy Development (DPD). Leading FDAs implementationof the Drug Competition Action Plan (DCAP).

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Documentation Labelling Drug Development 144

Express Pharma

JANUARY 1, 2025

It has a strong presence across various modalities, such as RNAi, ADC, peptides, lipids and oligonucleotides, and manufacturing techniques, such as flow chemistry, enzymatic processes, biocatalysis and fermentation, offering a broad range of technology capabilities for drug development. Its revenue from operations increased by 34.3

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pharmaphorum

JUNE 24, 2021

The original formulation has started to lose patent protection however, and a gaggle of drug developers – including Samsung Bioepis/Biogen, Hospira and Formycon/Bioeq – are already preparing to enter the US market with lower-cost biosimilars , with the first rivals expected to launch before year-end. billion in 2020 revenues.

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Diabetes Biosimilars Drug Development 95

FDA Law Blog: Biosimilars

DECEMBER 6, 2024

As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development.

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Documentation Packaging Clinical Pharmacology Drug Development 59

PharmaShots

FEBRUARY 27, 2023

As a renowned chemist, Dr. Senanayake discussed the need to adopt green chemistry in the process of drug development for cost reduction, timely innovation, and generating less waste than the standard process. To provide the audience with an Indian viewpoint, the presenters pointed out the country's requirements for biosimilar PV.

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Biosimilars Diabetes Packaging Hospitals 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.

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Biosimilars Dosage Drug Pricing Pharmaceutical Companies 96