FDA Law Blog: Biosimilars

DECEMBER 3, 2023

CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028. The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. Final Guidance at 2. of the total expenditures for all Part D drugs in 2021.

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Pharmaceutical Technology

OCTOBER 5, 2022

According to GlobalData’s analyst consensus forecast, Yescarta is expected to reach peak sales of $1.8bn in 2028, and Kymriah is expected to reach sales of $686m in the same year. Autologous CAR-T agents are now becoming the standard of care for patients in the third line and later settings, providing lucrative returns for these agents.

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Pharmaceutical Technology

DECEMBER 11, 2022

Pirtobrutinib has received an FDA orphan drug designation for CLL, and given the true orphan status of RT, regulatory approval with an RT-specific label could be pursued swiftly with this data. GlobalData’s consensus analyst forecast database projects peak sales for pirtobrutinib to reach $892 million by 2028, and $4.8

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Labelling 59

Pharmaceutical Technology

DECEMBER 16, 2022

This therapy is currently in Phase II development and is expected to launch in the US and 5EU in 2027 and 2028, respectively. GlobalData’s report also covers a third pipeline candidate, quinagolide, a dopamine receptor antagonist being developed by Ferring Pharmaceuticals.

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Pharmaceutical Technology

SEPTEMBER 2, 2022

The product labels do not help either; the FDA has approved all such agents for use at the fifth line of therapy or later, while the EMA has adopted the stance of fourth line of therapy or later use for these agents (Figure 1). Should CAR-T cells, or antibodies be used first? Does Blenrep have an efficacy advantage over Tecvayli?

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Labelling 59

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 64

PharmaShots

JUNE 1, 2023

We are conducting an open-label, dose-escalation, phase I/II study PDC-LUNG-101 assessing the safety, tolerability, immunogenicity, and the preliminary clinical activity of therapeutic cancer vaccine PDC*lung, associated or not with anti-PD1 treatment in patients with non-small-cell lung cancer (NSCLC).

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pharmaphorum

JANUARY 14, 2021

Whilst the details of China’s economic recovery have been disputed, one forecaster, the Centre for Economics and Business Research, has predicted that China will now overtake the US as the world’s leading economy in 2028, five years earlier than was previously forecast. About the author.

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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

JUNE 16, 2023

Merck ( MSD ) has announced updated results with Keytruda (pembrolizumab) in the Phase III Keynote-811 trial, which opens up the possibility of changing the checkpoint inhibitor’s label in HER2-positive gastric or GEJ adenocarcinoma so it’s based on the tumour’s PD-L1 biomarker status. It showed promising event-free survival (EFS) of 62.4%

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Express Pharma

NOVEMBER 13, 2024

million by 2031, assuming the asset attains approval in 2028. Additionally, patients who completed PHOENYCS GO will continue to be assessed in a long-term open-label study, underscoring both companies’ commitment to understanding the sustained benefits and safety profile of dapirolizumab pegol.”

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Pharmaceutical Technology

DECEMBER 22, 2022

The new joint procedure will launch in Q1 2025 for oncology medicines and other advanced therapy medicinal products and extend to orphan drugs in 2028. However, he did point out that the joint assessment could be a useful way of narrowing down typically broad EMA label content to specific patient populations.

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Pharmaceutical Companies Pharmaceutical Companies Labelling Communication 52

FDA Law Blog: Biosimilars

JANUARY 2, 2025

Under the proposed rule, any raw whole fruits and vegetables could be labeled healthy no matter the level of added sugars, sodium, or saturated fat. Therefore, manufacturers must maintain records for foods bearing a healthy claim unless it is clear from the foods mandatory labeling information.

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Labelling Documentation 52