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. In the second category—limiting blockades to marketing—are efforts to limit blocking exclusivities and induced infringement liability.

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Labelling Biosimilars Drug Pricing Dosage 104

Putting Patients First Blog

SEPTEMBER 3, 2024

Overall, while the NHC appreciates CMS’ intent to streamline the data submission process and make it more accessible, we encourage ongoing dialogue and adjustments to ensure that the process remains patient-centered, efficient, and capable of capturing the full spectrum of information necessary to inform meaningful drug price negotiations.

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Drug Pricing Insurance Coverage and Processing Labelling Communication 52

FDA Law Blog: Biosimilars

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers.

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Drug Pricing Biosimilars Dosage Documentation 45

Putting Patients First Blog

JULY 2, 2024

General Comments The NHC appreciates CMS’ commitment to actively engaging with stakeholders, including patients, consumer advocates, and health experts, in implementing the Medicare Drug Price Negotiation Program (DPNP). It is crucial to consider how off-label uses will be evaluated and incorporated into the negotiation process.

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Drug Pricing Insurance Coverage and Processing Labelling HIPAA 52

Proxsys Rx

DECEMBER 11, 2023

We’ve expressed our own strong opinions on the topic in several blog posts, including this one. To learn how two hospitals we serve do just that, Click Here to read our blog post, “How To Manage A Director of Pharmacy’s Responsibilities And An Optimized 340B Program. Without Hiring More Staff.”

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Specialty Pharmacies Hospitals Drug Pricing Labelling 52

Proxsys Rx

MARCH 1, 2024

We’ve expressed our own strong opinions on the topic in several blog posts, including this one. To learn how two hospitals we serve do just that, Click Here to read our blog post, “How To Manage A Director of Pharmacy’s Responsibilities And An Optimized 340B Program. Without Hiring More Staff.”

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Specialty Pharmacies Hospitals Drug Pricing Labelling 40

Putting Patients First Blog

JANUARY 27, 2025

3 ,4, 5 As such, the NHC supports CMS proposal to ensure that Part D sponsors cover AOMs for obesity with clinical criteria that is not more restrictive than the FDA labeling for each AOM. Issue Brief: Improving Prescription Drug Price and Cost Transparency. 2 (2024): 206 214, [link] www.jmcp.org/doi/epdf/10.18553/jmcp.2024.30.2.206.

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Insurance Coverage and Processing Biosimilars Communication Department of Veterans Affairs 40