Drug Patent Watch

JANUARY 14, 2025

The Thyroid Association’s Concerns The American Thyroid Association (ATA) had raised concerns about the FDA’s methods for determining bioequivalence between levothyroxine products[2]. They recommended avoiding switching between levothyroxine products, leading to a preference for brand-name prescriptions.

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FDA Law Blog

JUNE 10, 2024

Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” By Sarah Wicks & Anne K.

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Compliance Bioequivalency Cosmetics Regulation 111

FDA Law Blog

JULY 6, 2021

Circuit, their client Nostrum Laboratories sought judicial review after FDA agreed to allow a certain type of study to establish bioequivalence for generic theophylline, Nostrum conducted those studies, and then FDA issued a CRL asking for new, time-consuming, expensive studies of a different sort.

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Bioequivalency Bioavailability Drugs Regulation 52

FDA Law Blog

FEBRUARY 26, 2024

FDA explained that its bioequivalence regulations at 21 C.F.R. Those regulations break “concentration” out from strength but only in certain contexts. Boehringer’s regulatory argument got no further traction. do not help Boehringer’s case. parenteral solutions) but is not typically broken out for others (e.g.,

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Production Bioequivalency Drugs Containment 59

The Pharma Data

AUGUST 5, 2020

Onset of B-cell depletion with subcutaneous administration of ofatumumab in relapsing multiple sclerosis: results from the APLIOS bioequivalence study. J Neurol Sci. 2003;206(2):165–71. 3. Bar-Or A, Fox E, Goodyear A, et al. Poster presentation at: ACTRIMS; February 2020; West Palm Beach, FL. 4. Hauser S, Bar-Or A, Cohen J, et al.

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Trials Medicine Production Containment 52

World of DTC Marketing

FEBRUARY 21, 2022

A new study estimates the causal effects of coupons for branded drugs without bioequivalent generics using variation in coupon introductions over time and comparing differential responses across enrollees in commercial and Medicare Advantage plans. At this point, one must wonder why the U.S. About those copay cards.

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Pharmaceutical Technology

OCTOBER 28, 2022

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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XTalks

FEBRUARY 8, 2021

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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Production Insulin Branding Generic Drugs 78

Delveinsight

FEBRUARY 5, 2021

The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products. Rather, the bioequivalence studies were performed using the 150 mg strength; and the data was extrapolated to the higher dose. Quitting smoking is an arduous, exhausting process. However, it is possible.

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FDA Law Blog

JULY 9, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks & Deborah L. For drugs, the relevant studies are any Phase 3 study or, as appropriate, another pivotal study of a new drug (other than bioavailability or bioequivalence studies). 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)).

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Clinical Trials Clinical Trials Development Drugs 59

Drug Patent Watch

FEBRUARY 17, 2025

The ANDA must also demonstrate that the generic drug is bioequivalent to the brand-name drug. Step 4: Labeling and Packaging Once the generic drug is approved, the manufacturer must ensure that its labeling and packaging comply with FDA regulations. Generic drugs must demonstrate bioequivalence to their brand-name counterparts.

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Generic Drugs Bioequivalency Drugs Branding 52

The Pharma Data

MAY 3, 2021

Chilean regulator sees no clouds over Sputnik vaccine despite Brazilian rejection ( Reuters ). Canada’s regulator holds Johnson & Johnson vaccine over Emergent link ( NYTimes ). UK Could Become ‘World Leader’ On Biosimilar Regulation ( Pink Sheet ). Coronavirus Pandemic.

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Gene Therapy Vaccine Vaccination Bioequivalency 52