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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “genericdrugs of the biopharma world.

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A Short-Term Gain for a Long-Term Loss? The Build Back Better Act’s Medicare Drug Price Negotiation Program Ignores Hatch-Waxman/BPCIA Realities. and that May Mean Big Bad Business for Generic Drug/Biosimilar Manufacturers

FDA Law Blog

139001 lays out a process by which the Secretary would: Identify “negotiation-eligible drugs” from among qualifying single-source drugs that are among the top 50 with the highest Part D spending, the top 50 with the highest Part B spending, and insulins. Here are the important points from the MedPac summary: Sec.

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

XTalks

It is a dipeptidyl peptidase-4 inhibitor that keeps insulin levels stable and reduces the amount of glucose produced by the body. 5) Toujeo (insulin glargine) Toujeo is very similar to Lantus in that both are insulin glargine, except Toujeo is more concentrated. Merck’s total global revenue from Lagevrio was $5.68 billion ($8.72

Sales 98
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Recon: Moderna lifts guidance on COVID vaccine sales; US backing of patent waiver causes stir

The Pharma Data

FDA extends research agreement with MIT-licensed organ-on-chip systems ( Endpoints ). Sherrill, Kinzinger Lead Bipartisan Letter to House Appropriations Committee Urging Them Not to Block E-Labeling of Prescription Drugs ( Press ). Lilly inks smart insulin pen deals with Roche, Dexcom and more ( Fierce ).

Sales 52
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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.