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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

While there are currently six biosimilars for AbbVie’s Humira (adalimumab) that have been approved by the regulator, the company’s patents prevent biosimilars from being launched until 2023. The regulator allows biosimilars to show slight differences in clinically inactive components of a product.

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New Type 2 Diabetes Drug Brenzavvy Wins FDA Approval

XTalks

XTALKS WEBINAR: Review of Key Trends for Life Science Commercial Teams in 2023 Register for this free on-demand webinar to learn about the latest trends in sales and marketing campaigns that could help bolster commercial success for life science companies this year.

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Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. billion in pharmaceutical sales from 2021. In contrast, several drugs experienced sale declines, such as Remicade (infliximab), an old immunology medication that continues to decline due to the rise of biosimilars since 2016.

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The Drug Reimportation Law Curtails Wholesale Not Personal Importation: Who Knew?

Pharmacy Checkers

On behalf of Prescription Justice, I submitted comments to the FDA in response to its request for public comments on its draft guidance called: “Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry.”.

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Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. Reg. 70796”

Pharmacy Checkers

The FDA should be commended for its effort to create rules, pursuant to Section 804 of the Food, Drug and Cosmetic Act, that can lead to a regulated and safe channel of wholesale drug importation from Canada to help reduce cost burdens on states and consumers. counterparts. J)(2) Waiver authority. for drug safety.