Big Molecule Watch

SEPTEMBER 25, 2023

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.”

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FDA Law Blog: Biosimilars

SEPTEMBER 23, 2024

Hatch passed away in April 2022), but Eli Mazour’s Clause8 podcast from October 2018 already covered that ground: see Henry Waxman – The Hatch-Waxman Act and a Life In Congress. So what should we do here on the FDA Law Blog to celebrate the 40th anniversary of Hatch-Waxman? We thought about an interview with Rep. Waxman (sadly, Sen.

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PharmaState Academy

MAY 16, 2023

Over the next 15 to 20 years, you can expect pharma business models of today to be metamorphosed by biopharmaceuticals and biosimilars. PFS are ready to use disposable syringes containing premeasured dosage of the medicine. Biopharma technologies will develop new ways to treat and cure a wide range of diseases. And the biggest benefit?

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FDA Law Blog: Biosimilars

JUNE 16, 2023

We expect the Minnesota law to face Commerce Clause, vagueness, and possibly other constitutional challenges, similar to those brought against a generic price gouging prohibition in Maryland that was struck down by the Fourth Circuit in 2018 (see our post here ).

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PharmaShots

JUNE 28, 2023

The increase in ENBREL sales for 2019 vs 2018 was primarily driven by favorable changes to estimated sales deductions and an increase in net selling price, partially offset by lower unit demand. Some of its approved biosimilars are mentioned below along with the regulatory bodies they are approved by*. Enbrel Prescribing Information 3.

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PharmaShots

APRIL 26, 2023

The report is concluded with an engaging SWOT analysis and edifying KOL reviews Active Ingredient: Dupilumab Dosage Forms & Strengths: Single-Dose Pre-Filled Syringe with Needle Shield Injection: 300 mg/2 mL, 200 mg/1.14 mL, 100 mg/0.67 mL Single-Dose Pre-filled pen Injection: 300 mg/2 mL, 200 mg/1.14 mL, 100 mg/0.67

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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. This came after an attempted sell-off starting last October was met with no formal offers from a buyer.

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