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. NDA or BLA drugs). Vanda Pharmaceuticals, Inc. Centers for Medicare and Medicaid Servs., 23-1457 (4th Cir.

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Drug Patent Watch

JANUARY 7, 2025

Generic drugs are pharmaceutical products that contain the same active ingredients as their brand-name counterparts. They’re designed to be bioequivalent, meaning they have the same dosage, strength, route of administration, quality, and intended use as the original brand-name drug.

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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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Big Molecule Watch

MARCH 1, 2024

Today, the district court for the District of Delaware (Judge Connolly) granted the government’s motion for summary judgment on all claims brought by AstraZeneca in its Complaint challenging the Drug Price Negotiation Program of the IRA. There are now seven remaining lawsuits challenging the Drug Price Negotiation Program of the IRA.

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Proxsys Rx

MAY 18, 2023

The skyrocketing costs of prescription drugs It’s no secret that prescription drug prices are rising faster than the rate of inflation, forcing employers to shift more of their prescription benefit costs to their employees and families. This usually means higher deductibles, higher co-pays, and lower morale among employees.

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European Pharmaceutical Review

JUNE 24, 2022

The review was impacted by Brexit and the COVID-19 pandemic, which compounded existing issues surrounding high drug pricing and patient access that had been brewing since 2016 and highlighted several shortcomings in the EU’s pharmaceutical system. This obviously presents a huge magnitude of risk for drug developers,” he noted.

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Pharmaceutical Technology

JANUARY 6, 2023

The alleged actions violated the Hatch-Waxman Act, formally known as the “Drug Price Competition and Patent Term Restoration Act of 1984,” which allows generic manufacturers to market their generic versions of previously approved generic medications. These actions allegedly led to the extension of Novartis’ patents.

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Viseven

JANUARY 13, 2023

Defining Drugs Dosage Even when all stages of the clinical trial are over, there are still many things pharmacists and doctors may learn after patients will get access to the new treatment. HEOR Analysis of Patients The social value of the drug in increasing the quality of life is also an important issue.

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Proxsys Rx

MARCH 23, 2023

As with other discount cards, patients can use their provider’s easy-to-use MedServRx website to search — and compare prices among participating local pharmacies — for drugs by name. This added search capability gives patients the advantage of true price comparison based on their individual needs.

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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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Big Molecule Watch

JANUARY 19, 2024

Passage of and Challenges to the Inflation Reduction Act In August 2023 , HHS announced the ten drugs that will be included in the first year of the Inflation Reduction Act’s new Drug Price Negotiation Program. In December 2023, the PTAB instituted all of these IPR petitions.

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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. Patents are often described as the ‘lifeblood’ of pharmaceutical companies.

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Pharmaceutical Technology

SEPTEMBER 26, 2022

Novartis said in August that it intended to shut down its Sandoz oral solid dosage plant in Wilson, North Carolina, which provides tablets to Canada and the US, next year. Innovative drug development can be costly and risky due to clinical trial attrition of unproven drugs, but can provide a high return on investment when successful.

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Pharmaceutical Commerce

JUNE 9, 2025

As of now, supply for this coming season matches last year’s total dosage, with production expected to continue. Expanded manufacturing capacity for the upcoming season Now, the Sanofi-AstraZeneca partnership has resulted in tripled production capacity, along with twice the number of manufacturing facilities.

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Drug Patent Watch

DECEMBER 19, 2024

These protect the core molecule or compound that gives a drug its therapeutic effect. Formulations and Dosage Forms Patents covering specific formulations or dosage forms can extend protection beyond the API. Q: What role does patent portfolio management play in drug pricing?

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