Pharma in Brief

FEBRUARY 8, 2024

For instance, the generic drug must be “the pharmaceutical equivalent of the [CRP]” and be “bioequivalent with the [CRP]”. According to the Notice, the alternate CRP is preferably another generic drug that has demonstrated bioequivalence with the “Dormant” innovative drug.

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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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Camargo

NOVEMBER 11, 2020

The guidance clarifies the differences between an RLD and an RS for use during in vivo bioequivalence studies to support an ANDA and how the Agency determines the appropriate RS to designate in the Orange Book.

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pharmaphorum

OCTOBER 21, 2020

Zosano Pharma has been hit by an FDA rejection of its marketing application for migraine drug Qtrypta, asking for new bioequivalence data. Qtrypta is Zosano’s lead product candidate, but the company is also working on a follow-up in phase 2/3 for cluster headache.

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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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pharmaphorum

JANUARY 18, 2023

NewAmsterdam said it is now selecting a formulated fixed-dose combination tablet of obicetrapib plus ezetimibe that will be tested in a phase 3 trial, as well as a study to make sure the formulation is bioequivalent to each drug delivered separately.

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FDA Law Blog

FEBRUARY 26, 2024

FDA explained that its bioequivalence regulations at 21 C.F.R. Here, FDA breaks our concentration from strength in the context of self-evident bioequivalence that would allow FDA to grant a biowaiver (requiring inactive ingredients to be present in the same concentration as the Reference Listed Drug), which is only narrowly applicable.

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FDA Law Blog

NOVEMBER 6, 2023

Admittedly, BiMo inspections (into items like adequacy of bioequivalence data, consistency of clinical trial data with medical records, and compliance with clinical trial protocols) lend themselves better to an RIE than assessing manufacturing compliance with regulatory requirements.

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The Pharma Data

DECEMBER 28, 2020

Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. Glucagon is indicated for the treatment of severe hypoglycemia and is also used as a diagnostic aid.

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Pharmacy Checkers

FEBRUARY 14, 2020

Sure enough, ConsumerLab.com discovered that the 300mg version was clearly not bioequivalent. Several years later, the FDA ordered bioequivalence tests and finally, through those results, which found, like ConsumerLab.com did, that the People’s Pharmacy was right, and forced the drug off the market.

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Drug Discovery World

AUGUST 22, 2023

In many cases, it is also challenging to apply traditional bioequivalence methods or to ensure clarity about the comparison model (in-vitro/in-vivo) needed to gain health authority approval. Also, sometimes traditional bioequivalence approaches will not be possible and investment in expensive clinical trials are warranted.

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Drug Discovery World

JULY 25, 2023

Healthy volunteers receive two administrations (placebo/active and active/active) one week apart, and measures of psychedelic effect are assessed after each dose.

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pharmaphorum

JANUARY 17, 2022

The company was slammed for restricting distribution of its drug so generic drug manufacturers couldn’t conduct bioequivalence tests or access a key ingredient used in the drug’s production.

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The Pharma Data

FEBRUARY 1, 2021

The FDA’s approval of the IM administration for Plegridy is based on data evaluating bioequivalence and adverse reactions associated with IM administration compared to SC administration in healthy volunteers. percent vs. 32.1 percent). MS, the coronavirus and vaccines – updated global advice. Available at: [link] Accessed: January 2021.

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Camargo

DECEMBER 13, 2021

On the contrary, due to the complexity involved in comparing the structures of biologics, selecting the correct sampling times to prove bioequivalence for both PK and biomarkers is of primary importance. The role of pharmacometrics for biosimilars is no less significant than for biologics.

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Camargo

JULY 8, 2021

In June, the FDA issued an updated (draft) guidance titled “ Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.” FDA Publishes Draft Guidance on Adverse Drug Experience Reporting for INDs and BA/BE Studies .

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Camargo

FEBRUARY 10, 2021

Pharmacokinetics (PK) and bioequivalence (BE) studies serve as the foundation of determining the fate of drug products. Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling.

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Pharmaceutical Technology

FEBRUARY 23, 2023

The studies established bioequivalence between acalabrutinib 100mg tablets and acalabrutinib 100mg capsules. Findings demonstrated that the Calquence capsule and tablet formulations are bioequivalent in the trials.

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The Pharma Data

NOVEMBER 17, 2021

The EC’s blessing of VUMERITY is grounded on data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA to establish bioequivalent exposure of monomethyl fumarate, the active metabolite, and reckoned in part on the well- established long- term efficacity and safety profile of TECFIDERA. Encyclopedically, an estimated2.8

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The Pharma Data

SEPTEMBER 26, 2021

The positive CHMP opinion was supported data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA® (dimethyl fumarate) to determine bioequivalent exposure of monomethyl fumarate, the active metabolite, and relied partially on the well-established long-term safety and efficacy profile of TECFIDERA.

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The Pharma Data

APRIL 11, 2023

Dose proportionality and bioequivalence studies demonstrate once-daily AUSTEDO XR is therapeutically equivalent to twice-daily AUSTEDO ® (deutetrabenazine) tablets The U.S. Bioequivalence and relative bioavailability were established between the once-daily and twice-daily tablet formulations, with no new safety findings emerging.

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Delveinsight

FEBRUARY 5, 2021

Rather, the bioequivalence studies were performed using the 150 mg strength; and the data was extrapolated to the higher dose. Two doses, bupropion XL 15 mg and bupropion XL 300 were approved. Since the higher dose was associated with the risks of seizures, the FDA granted a waiver in its testing.

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FDA Law Blog

JULY 24, 2022

TE Codes, FDA explains, are assigned for multisource prescription products based on pharmaceutical equivalence, bioequivalence, and product safety and efficacy profile for the conditions of use specified in the labeling. FDA goes through each of the relevant terms and the therapeutic equivalence requirements.

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Pharmaceutical Technology

JULY 25, 2022

Drugs with an AB rating meet the required bioequivalence. But while this could be a factor why generics are not included on formularies in preferred spots, PBMs could also promote the use of some treatments, says Frank. For example, AB rated drugs could see an automatic substitution for a generic, he explains.

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XTalks

FEBRUARY 8, 2021

Unlike small-molecule generic drugs, biosimilars do not need to demonstrate bioequivalence to the innovator product. MYTH: Clinical pharmacology studies of biosimilars aim to establish safety and effectiveness.

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Druggist

MARCH 25, 2021

Generic medicines must go through bioequivalence studies to show that generic medicine produces the same amount of active drug in the body. Bioequivalent studies may involve humans or animals (EMA, 2012). . An extensive research study looked at bioequivalent information from 2070 studies that took place over 12 years.

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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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FDA Law Blog

JANUARY 23, 2023

This subsection requires sponsors of any phase 3 or other pivotal drug study (other than bioavailability or bioequivalence studies) to submit diversity action plans by the time they submit the study protocol. Clinical Trial Diversity Under FDORA FDORA adds subsection 505(z) to the Food, Drug, and Cosmetic Act (FDC Act).

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The Pharma Data

DECEMBER 17, 2020

TLC’s Ampholipad (amphotericin B liposome for injection) for the treatment of systemic fungal infections, is the only complex generic drug which has shown bioequivalence to Gilead’s AmBisome ® in all three forms, proving its sameness as the originator.

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The Pharma Data

DECEMBER 27, 2020

Acer Therapeutics announced full enrollment of trial evaluating the bioequivalence of ACER-001 compared to Buphenyl (sodium phenylbutyrate) for urea cycle disorders. ACER-001 is a taste-masked, immediate-release proprietary powder formulation for oral administration of sodium phenylbutyrate (NaPB) via suspension.

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The Pharma Data

AUGUST 9, 2021

Food and Drug Administration (FDA) approved SKYRIZI 150 mg in April based on data from three clinical trials showing the single-dose SKYRIZI 150 mg injection was bioequivalent, working the same as two injections of SKYRIZI 75 mg per dose with a consistent efficacy and safety profile. .” The U.S.

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Pharmaceutical Technology

JANUARY 6, 2023

In vitro release testing to demonstrate bioequivalence. Even the smallest details can have a big impact on the end result, especially when it comes to the sensory characteristics and the bioequivalence of a topical product.

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The Pharma Data

MAY 3, 2021

Korea To Toughen Co-Bioequivalence Study System Amid Generic Quality Issue ( Pink Sheet ). . Amid JAK safety uncertainty, AbbVie says latest data support its key launch Rinvoq ( Fierce ). UK Could Become ‘World Leader’ On Biosimilar Regulation ( Pink Sheet ). Medtech. Mass.

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Pharmaceutical Technology

FEBRUARY 23, 2023

The BCS is a regulatory tool that is used to justify clinical biowaivers for certain types of compounds (BCS Class I and III) based on dissolution data, allowing sponsors to justify not performing clinical bioequivalence studies when changing a formulation.

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