Safe Biologics

DECEMBER 6, 2023

prescribers have high confidence in the safety and efficacy of biosimilars, a majority (58%) oppose third-party switching of a patient’s biologic medicine for non-medical (e.g. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber. and worldwide.”

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FDA Law Blog: Biosimilars

APRIL 2, 2024

Perhaps unsurprisingly given the extraordinary focus on drug pricing in the last decade, generic competition—FDA’s only real way to have an effect on drug pricing—tops this year’s list.

Labelling 104

Labelling Biosimilars Drug Pricing Dosage 104

Pharmaceutical Technology

JANUARY 31, 2023

The US omnibus bill passed in late December 2022 will give the agency greater powers to regulate accelerated approval drugs, while the Inflation Reduction Act’s lowering of drug prices will create an uncertain environment for drug developers, he said.

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Drug Pricing Biosimilars Drug Development 52

Express Pharma

SEPTEMBER 6, 2023

Known as biosimilars, these biopharma products are highly similar to innovator products and have no clinically meaningful dissimilarities, especially in terms of efficacy, safety or quality. Indian pharma players could play a key role in positioning biosimilars as superior products to costly biologics.

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Insurance Coverage and Processing Biosimilars Generic Medicine Drug Pricing 59

Pharmaceutical Technology

DECEMBER 9, 2022

There are also strict price controls, which in some cases can limit profitability for manufacturers. Brazilian public spending on healthcare, drug pricing reforms and remote medicine. These treatments may still be in development or already have approval somewhere in the world. </p>

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

The LMG awards are reflective of HPM’s excellence across several of our core life sciences practices, from controlled substances work to drug development, to Hatch-Waxman, to drug pricing, to medical device regulation. is the largest dedicated food and drug law firm in the country.

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Controlled Substances Drug Pricing Drug Development 40

Pharma Marketing Network

MAY 11, 2025

accelerates its crackdown on drug pricing through new legislation and regulatory enforcement, pharma companies in China, India, Japan, and South Korea are feeling the ripple effect. This move marked a major shift in how drug pricing is managed in the United Statesa market that contributes significantly to global pharma revenues.

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Drug Pricing Biosimilars Communication Immunization 59

Safe Biologics

OCTOBER 10, 2023

ASBM Statement on Announcement of Medicare Drug Price-Setting List On August 29th, the Centers for Medicare & Medicaid Services (CMS) announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed into law last year.

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Biosimilars Drug Pricing Drug Development 130

Safe Biologics

JUNE 12, 2023

Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA).

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Biosimilars Drug Pricing Compounding Drug Development 130

Safe Biologics

JUNE 12, 2023

Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA).

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Biosimilars Drug Pricing Compounding Drug Development 100

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. CN202010111235.3A.

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Biosimilars Dosage Drug Pricing Pharmaceutical Companies 96

Pharmaceutical Technology

SEPTEMBER 26, 2022

The company told GlobalData PharmSource: “The biosimilar facilities in Austria and Slovenia would continue to manufacture biosimilars for Sandoz under a contractual agreement with Novartis. These highlight the parent company’s focus on innovative and high-value drug development.

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Biosimilars Drug Development Vaccines Dosage 64

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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Drug Pricing Biosimilars Vaccines Drug Development 150

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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