FDA Law Blog: Biosimilars

JUNE 2, 2023

Absent from the statute is any requirement to report information on manufacturer costs and price setting. Nevertheless, riding on the wave of drug price transparency legislation in several states and similar legislative proposals in Congress, CMS is proposing to expand the MDRP into the realm of drug price transparency reporting.

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Labelling Vaccines Drug Pricing Immunity 59

Pharma in Brief

JANUARY 10, 2024

Expected highlights for 2024 include a final PTA regime, more details on PMPRB drug pricing guidelines and national pharmacare, and fall-out from the US mass drug importation program targeting Canadian medicines. billion over three years to help increase drug access and affordability (see here ).The Rare disease strategy.

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Safe Biologics

APRIL 25, 2023

By Michael Reilly, Executive Director, Alliance for Safe Biologic Medicines (ASBM) ASBM recently submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the proposed Medicare Drug Price Negotiation Plan. Price controls, as proposed in the negotiation plan, may jeopardize this success.

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Safe Biologics

APRIL 25, 2023

By Michael Reilly, Executive Director, Alliance for Safe Biologic Medicines (ASBM) ASBM recently submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the proposed Medicare Drug Price Negotiation Plan. Price controls, as proposed in the negotiation plan, may jeopardize this success.

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Safe Biologics

SEPTEMBER 11, 2023

September 11, 2023 The Centers for Medicare & Medicaid Services (CMS) recently announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed in to law last year. 1] 90% of new cancer drugs are available in the U.S.

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Express Pharma

FEBRUARY 10, 2025

India trends: The power of AI and data analytics is ushering generative AI, along with AI and ML, into the Indian biopharma industry, contributing to areas such as disease understanding and vaccine development. India is streamlining processes for faster approvals of biologics and biosimilars, aiming to speed up access to effective therapies.

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Express Pharma

APRIL 1, 2025

While this strategic shift supports supply chain resilience, it may also elevate production costs and drug pricesraising concerns around affordability as emerging markets pursue regulatory reforms to boost access to biosimilars and biologics, says GlobalData.

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pharmaphorum

JANUARY 22, 2021

We don’t believe there will be draconian price cuts, for the same reason. The Biden administration could put additional scrutiny on drug prices, but more drastic measures, such as allowing Medicare to negotiate with pharma companies directly, are still unlikely.”. ” Science first.

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Drug Pricing Packaging Biosimilars Pharmaceutical Companies 63

Safe Biologics

MARCH 10, 2025

This expansion continues a flawed policy that threatens innovation and jeopardizes patient access to critical treatments, including drugs vital for cancer treatment and popular new weight loss medications that have transformed the management of obesity and related conditions. Read the full statement here.

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