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In the News: October Regulatory and Development Updates

Camargo

Labeling regulations prohibit reminder ads for products with boxed warnings, which the FDA requires when a drug product has very serious risks. The generic drug must also have the same labeling as the RLD (except for differences permitted under the Agency regulations).

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Quality by design with a focus on biosimilars

Pharmaceutical Technology

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug. For biosimilars, however, this process is slightly more complex.

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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. Expanded access to experimental biologics. BLA process (CBER).

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Novartis announces NEJM publication of Phase III ASCLEPIOS trials demonstrating superior efficacy of ofatumumab in patients with relapsing multiple sclerosis

The Pharma Data

Onset of B-cell depletion with subcutaneous administration of ofatumumab in relapsing multiple sclerosis: results from the APLIOS bioequivalence study. Ofatumumab versus teriflunomide in relapsing multiple sclerosis: Analysis of no evidence of disease activity (NEDA-3) from ASCLEPIOS I and II trials. Eur J Neurol. 2020;27(S1).

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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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Recon: W. VA opioid MDL bellwether gets underway; Moderna, Sweden deals give boost to COVAX

The Pharma Data

Drug distributors face off against West Virginia in billion-dollar opioid trial ( Reuters ) ( Law360 ). Chilean regulator sees no clouds over Sputnik vaccine despite Brazilian rejection ( Reuters ). Canada’s regulator holds Johnson & Johnson vaccine over Emergent link ( NYTimes ).