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The role of biosimilars in reducing out-of-pocket costs for patients

Drug Patent Watch

Breaking Down Barriers to Affordable Healthcare: The Power of Biosimilars As we navigate the complex landscape of modern healthcare, one thing is clear: the cost of prescription medications is a significant burden for many patients. So, how do biosimilars work? But the benefits of biosimilars extend far beyond individual patients.

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Draft Guidance on Biosimilars and Interchangeables Tries to Smooth Path for Post-Approval Changes

FDA Law Blog: Biosimilars

In areas like biologics, biosimilars, and interchangeable biosimilars, where emerging technologies meet regulatory complexities, this is perhaps a wise strategy. The top line from FDA for any cGMP-governed industry like these is always going to be that quality matters.

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Surprise! Thanks to the IRA, Part D Plans Will Prefer High-List, High-Rebate Drugs

Drug Channels

Below, I explain why the IRA will encourage Part D plans to prefer high-list, high-rebate specialty drugs , even as the government and manufacturers will prefer a low-list-price version. Just another IRA-inflicted hit for biosimilars? The warped incentives don't stop there.

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Sandoz confirms late-stage clinical development plans for proposed biosimilar aflibercept, a key ophthalmology medicine

The Pharma Data

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. The initiation of this study marks an important milestone in the development of our biosimilar aflibercept.

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COMMERCIALIZATION AND LICENSE AGREEMENT FOR PROPOSED BIOSIMILAR CURRENTLY IN PHASE 3 WITH THE POTENTIAL TO TREAT MODERATE TO SEVERE RHEUMATOID ARTHRITIS

The Pharma Data

Biogen enters into a commercialization and license agreement to develop, manufacture and commercialize BAT1806, a proposed biosimilar referencing ACTEMRA ® (tocilizumab). Biosimilars have the potential to enable greater access to marketed biologic therapies while generating cost savings and healthcare sustainability. Biogen Inc.

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Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars

The Pharma Data

Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced a multi-year partnership with Just – Evotec Biologics, the Seattle-based subsidiary of Evotec SE.

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HP&M Seeks Attorney with Significant Experience in Government Discount Programs and Price Reporting

FDA Law Blog: Biosimilars

HP&M) seeks to add an experienced attorney (7+ years) to our government discount program and price reporting practice. Hyman, Phelps & McNamara, P.C. (HP&M)