Drug Channels

NOVEMBER 15, 2021

PLUS: During the webinar, Dr. Fein will give participants an opportunity to unmute themselves and ask live questions.

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Specialty Pharmacies Drug Pricing Biosimilars 72

FDA Law Blog: Biosimilars

MARCH 18, 2025

Even though the PTE provisions established in the Drug Price Competition and Patent Restoration Act are forty-plus years old, courts are still grappling with questions about how to best implement the Patent Term Extension.

Drug Pricing 59

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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.

Insurance Coverage and Processing 59

Insurance Coverage and Processing Biosimilars Generic Medicine Drug Pricing 59

FDA Law Blog: Biosimilars

SEPTEMBER 23, 2024

Hatch Foundation’s For cheap generic drug prices, you can thank 40 years of Hatch-Waxman We Work For Health’s Hatch-Waxman Act: Celebrating 40 Years of a Balanced and Innovative Drug Ecosystem Tradeoffs’ Race to the Bottom Series FDA CDER Conversations – 40th Anniversary of the Generic Drug Approval Pathway The U.S.

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Dosage Drug Pricing 59

FDA Law Blog: Biosimilars

APRIL 16, 2024

Under the Medicaid Drug Rebate statute, a pharmaceutical manufacturer whose drug prices increase faster than the rate of inflation must pay additional per-unit rebates to the program. We previously blogged on the district court’s decision last year. Vanda Pharmaceuticals, Inc. Centers for Medicare and Medicaid Servs.,

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FDA Law Blog: Biosimilars

JUNE 26, 2023

Kirschenbaum — As we and others closely following drug pricing have predicted, multiple additional lawsuits have followed in the wake of Merck’s challenge to the Inflation Reduction Act (IRA) price negotiation provisions in the D.C. By Faraz Siddiqui & Alan M. federal district court on June 6 (see our post here ).

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Drug Pricing 59

FDA Law Blog: Biosimilars

AUGUST 14, 2024

In addition to the widely publicized drug price negotiation program, the IRA established inflation rebate programs under Medicare Part B and Part D.

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Drug Pricing Pharmaceutical Manufacturing 59

HealthPartners

JULY 21, 2021

For example, members can compare drug prices at pharmacies or find a network provider. We monitor the drug pipeline to predict and plan for new and lower-cost drug options like generics and biosimilars. This results is savings of 80% off the list price of generic biologics rather than discounts of 55-60%.

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Biosimilars Specialty Pharmacies Mail-Order Pharmacies Health Insurance Companies 52

FDA Law Blog: Biosimilars

OCTOBER 4, 2023

By Faraz Siddiqui — Last week, a federal court in Ohio denied a preliminary injunction motion by four Chambers of Commerce in their lawsuit against the Medicare Drug Price Negotiation Program.

Drug Pricing 59

Drug Pricing Pharmaceutical Manufacturing Immunity Immunization 59

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. That combined depth and breadth of experience is why clients come to us.

Controlled Substances 40

Controlled Substances Drug Pricing Drug Development 40

FDA Law Blog: Biosimilars

MARCH 5, 2024

By Faraz Siddiqui — Last Friday, the Delaware District Court rejected AstraZeneca’s lawsuit against the Medicare Drug Price Negotiation Program enacted under the Inflation Reduction Act (IRA) and CMS’s guidance implementing it.

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Dosage Drug Pricing 64

FDA Law Blog: Biosimilars

MARCH 24, 2024

Under this law, manufacturers may not deny contract pharmacies access to a covered entity’s 340B drugs, or deny 340B drug pricing to covered entities who use contract pharmacies for distribution. Code Ann. § 23-92-604(c)(1), (2) (Act 1103).

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Drug Pricing 59

Putting Patients First Blog

JANUARY 27, 2025

Formulary Inclusion and Placement of Generics and Biosimilars The NHC supports CMS proposals to improve formulary practices by prioritizing access to generics, biosimilars, and other cost-effective medications in the Medicare Part D program.

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Insurance Coverage and Processing Biosimilars Communication Department of Veterans Affairs 40

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

FDA Law Blog: Biosimilars

MARCH 12, 2025

Karst will speak at a two-part session: Part I Chevron Overturned: Examining Challenges Against the FDA and How the Death of the Doctrine Could Impact Drug Approvals and Exclusivities; and Part II Anticipating the New Administrations Impact on FDA Policies and Regulations. FDA Law Blog is a conference media partner.

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Drug Pricing 59

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. The primary manufacturer of a selected drug may also request CMS to terminate its agreement if they are unwilling to participate in the Medicare Drug Price Negotiation.

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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

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.

Drug Pricing 130

Drug Pricing Biosimilars Vaccines 130

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.

Drug Pricing 130

Drug Pricing Biosimilars Vaccines 130