Safe Biologics

FEBRUARY 1, 2024

The CHMP recognizes that there may be the potential to waive certain clinical data requirements even for complex biosimilars such as mAbs based on solid evidence of quality comparability.

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Biosimilars Documentation Drug Pricing 130

Pharmaceutical Technology

FEBRUARY 24, 2023

But the EU draft document says that the changes will make medicines more affordable, improve unequal access to medicines across the EU, and fulfil unmet patient needs. He pointed out that Europe was the first region to approve biosimilars. You can compare timelines.

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Biosimilars Documentation 64

FDA Law Blog: Biosimilars

JUNE 21, 2023

As acknowledged in the Strategic Priorities document, certain demographic groups may have limited access to necessary treatments and diagnostics. For those who are interested in learning more about the decentralized clinical trial draft guidance, please check out the FDA’s webinar on June 20, 2023.

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Documentation Hospitals 45

FDA Law Blog: Biosimilars

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

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Documentation Labelling Communication 45

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

During the October 31, 2023 webinar discussing the proposed rule, stakeholders sought clarity from FDA officials on the Agency’s plan to address the resource gap. OHT-7’s well documented meltdown during the COVID-19 public health emergency should serve as an object lesson. 24] These submissions all related to a single disease.

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Research Laboratories Documentation 69

Safe Biologics

MAY 10, 2024

Biden Administration HHS Budget Would Permit Third-Party Substitution of All Biosimilars On March 11th, the Biden Administration released its FY25 HHS Budget. and Europe alike, prescribers can already substitute any biosimilar for its reference product. Currently there are 10 biosimilars that can be substituted by U.S.

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Biosimilars Drug Pricing Documentation Labelling 130

Pharma in Brief

JUNE 21, 2020

Medicines with an annual treatment cost >150% of GDP/capita or maximum expected market size >$50 M will be classified as Category I, except biosimilars and generics. Medicines falling below these thresholds, as well as biosimilars and generics, will be classified as Category II. The consultation: next steps.

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Biosimilars Generic Medicine Dosage Documentation 40