FDA Law Blog: Biosimilars

OCTOBER 6, 2023

Labs must also begin complying with device labeling requirements (21 C.F.R. Stage 2 (two years after issuance of the final rule) : Register with FDA as a device establishment and list LDTs performed, pursuant to 21 C.F.R. Part 801) and investigational device exemption requirements (21 C.F.R.

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Labelling 62

Quality Matters

MARCH 1, 2024

PGx presents opportunities for USP to collaborate with key stakeholders who are already developing PGx standards and guidelines and to apply its standards-setting process to establish alignment and consistency in PGx standards. DTx is projected to have a cumulative annual growth rate of up to 25.4% in the U.S.

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Labelling Compounding 52

pharmaphorum

JUNE 8, 2021

Broad label questioned. billion in 2027. ICER argues that Aduhelm was effectively approved on the strength of a biomarker – removing amyloid from the brain – rather than clinical outcomes, which is “puzzling” as other drugs have been shown to remove amyloid from the brain yet failed to help patients.

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Labelling Drug Pricing 98

Pharmaceutical Technology

JANUARY 10, 2023

Specifically, across all the major classes there are significant developments, label updates, and biosimilar launches that are driving their growth.

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Biosimilars Labelling Diabetes Compounding 52

pharmaphorum

JANUARY 10, 2023

New drugs for immunological and inflammatory diseases feature prominently among new product launches this year that could top $1 billion in annual sales by 2027 or be clinical “game changers,” according to Clarivate.

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Labelling Diabetes 52

European Pharmaceutical Review

FEBRUARY 22, 2023

1 Used to treat a range of chronic diseases (eg, diabetes, rheumatoid arthritis, psoriasis, Crohn’s disease, haemophilia, etc), it is projected that the sales of biologics will rise from $380 billion in 2022 to $416 billion in 2023, and to almost $600 billion in 2027.

Biosimilars 105

Biosimilars Diabetes Immunity Immunization 105

pharmaphorum

DECEMBER 29, 2021

Dupixent’s label currently calls for dosing every two weeks for all patients. billion in 2027 and newer entrants struggling to dislodge it from its position after so many years of clinician experience. One point in Adbry’s favour is that some patients will be able to administer the injectable drug just once per month.

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Labelling 111

Safe Biologics

MAY 10, 2024

Without a change, the number of eligible drugs will increase to 15 in 2027 and 2028 and to 20 every year thereafter. CMS is currently working to set prices for 10 drugs, with the final prices set to be announced by Sept. 1 and go into effect in 2026.

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Biosimilars Drug Pricing Documentation Labelling 130

Pharmaceutical Technology

NOVEMBER 30, 2022

weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients. In a Phase II study, CagriSema achieved a numerically higher body weight reduction of 15.6%

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Insurance Coverage and Processing Diabetes Labelling Communication 105

Pharmaceutical Technology

NOVEMBER 30, 2022

weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients. In a Phase II study, CagriSema achieved a numerically higher body weight reduction of 15.6%

Insurance Coverage and Processing 98

Insurance Coverage and Processing Diabetes Labelling Communication 98

Pharmaceutical Technology

APRIL 24, 2023

Since then, the drug has been used off-label in breast cancer and other types of cancer. GlobalData predicts that Comirnaty’s sales will increase by more than 20% between 2024 and 2027. However, after a period of slow movement in the field, the FDA approved the first nanodrug, Doxil, for Kaposi sarcoma in 1995.

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Vaccines Immunity Immunization Medical Schools 59