FDA Law Blog

APRIL 8, 2025

This included ensuring FDA consensus on the recommendations in the PSGs and working with the Office of the Commissioner to ensure their timely publication, either in quarterly batches of PSGs or as a stand-alone PSG when ANDA bioequivalence recommendations may be the subject of a pending Citizen Petition.

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Generic Drugs Drugs Bioequivalency Production 144

BioTech 365

DECEMBER 11, 2021

Samsung Bioepis’ SB12 Soliris® (Eculizumab) Biosimilar Demonstrates PK, PD Bioequivalence in Phase 1 Study Samsung Bioepis’ SB12 Soliris® (Eculizumab) Biosimilar Demonstrates PK, PD Bioequivalence in Phase 1 Study Phase 1 study demonstrated pharmacokinetics (PK) equivalence and comparable pharmacodynamic (PD), safety, … Continue reading → (..)

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Bioequivalency 40

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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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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Development Bioequivalency Generic Drugs Production 242

Camargo

DECEMBER 22, 2021

For example, streamlined programs can be limited to literature searches, nonclinical studies, demonstration of bioequivalence to an approved product, or a combination of nonclinical and bioequivalence studies, and their relatively low costs may be appealing. Biowaiver Eligibility.

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Drug Patent Watch

JANUARY 22, 2025

They must file an Abbreviated New Drug Application (ANDA) with the FDA, which includes a certification that the generic drug is bioequivalent to the original. Generic manufacturers must file an ANDA with the FDA, which includes a certification of bioequivalence. This is where generic manufacturers come into play.

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Generic Drugs Bioequivalency Drugs FDA Approval 40

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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Drugs Manufacturing Production Marketing 298

FDA Law Blog

MARCH 5, 2023

Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. FDA may deny a PSG if the applicant’s bioequivalence testing started after the PSG publication.

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Bioequivalency Generic Drugs Packaging Packaging 59

Drug Patent Watch

DECEMBER 12, 2024

The drug featured: Unique delivery mechanism Multiple patents covering formulation and method of use Challenging bioequivalence requirements for potential generics By in-licensing this drug, the company gained a strong market position in a competitive therapeutic area, with generic entry delayed by several years.

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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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Production Manufacturing Development Bioequivalency 130

FDA Law Blog

SEPTEMBER 11, 2024

Note here that those initial risk assessments need not be reported, but FDA recommends that firms do report resulting changes to drug specifications like stability or bioequivalence.

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Drug Patent Watch

DECEMBER 10, 2024

These agencies set guidelines and regulations that generic drug manufacturers must follow to ensure that their products are bioequivalent to the innovator drug. One of the main challenges is ensuring bioequivalence with the innovator drug. EU, and other regions.

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Generic Drugs Development Bioequivalency Drugs 52

FDA Law Blog

JULY 23, 2024

Design validation may be covered by clinical studies, pharmacokinetic/pharmacodynamic or bioequivalence/bioavailability studies, literature, simulated bench testing, and/or anthropometric data and should include endpoints that have the capability of validating device performance.

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Drug Delivery Drugs Bioequivalency Production 105

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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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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Production Generic Drugs Drugs Bioequivalency 52

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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Bioequivalency Drugs Production Manufacturing 52

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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Development Bioequivalency Gene Expression Drugs 130

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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Generic Drugs Development Drugs Manufacturing 70

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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Branding FDA Approval Pharmacy Bioequivalency 62

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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Production Bioavailability In-Vivo In-Vitro 133

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

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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Manufacturing Compliance Drugs Clinical Trials 105

FDA Law Blog

JUNE 10, 2024

BIMO inspections can consist of on-site inspections, data audits, and remote regulatory assessments of nonclinical laboratories, clinical investigators, sponsors, contract research organizations (CROs), bioequivalence facilities, institutional review boards (IRBs), and postmarketing surveillance.

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Compliance Bioequivalency Cosmetics Regulation 111

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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Development Drugs Bioavailability In-Vivo 246

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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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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Bioequivalency FDA Approval Medicine Bioavailability 40

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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Bioequivalency Trials Licensing Licensing 59

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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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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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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Production Bioequivalency Drugs Containment 59

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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Clinical Trials Clinical Trials Trials Containment 40

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

ProRelix Research

JUNE 29, 2022

The post Oncology Bioequivalence Clinical Studies appeared first on ProRelix Research. According to the World Health Organization (WHO), cancer is the leading cause of death worldwide, accounting for nearly 10 million deaths in 2020 (1). In addition, GLOBACAN estimated 19.3 […].

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Bioequivalency Research Clinical Trials Clinical Trials 52

XTalks

NOVEMBER 6, 2024

This regulatory strategy leverages bioequivalence studies to expedite approval, positioning Gelteq’s gel as an alternative to traditional oral delivery forms. In the pharmaceutical segment, Gelteq advances its lead product — a gel-based pain management therapy — through the US Food and Drug Administration (FDA)’s 505(b)(2) pathway.

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Drug Delivery Drugs Bioequivalency Bioavailability 104

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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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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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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