Alpha Cognition announces bioequivalence study results for Alzheimer’s
Pharma Times
AUGUST 25, 2022
In 2019, there were over 850,000 people with dementia in the UK, representing one in every 14 people aged 65 and over
Bioequivalency Related Topics 
Oncology Bioequivalence Clinical Studies
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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FDA approves IntelGenx’s Rizafilm for acute migraine treatment
Pharmaceutical Technology
APRIL 18, 2023
The approval was based on successful results from a bioequivalence study comparing Rizafilm to Merck and Co’s Maxalt-MTL and the European reference Maxalt-Lingua. IntelGenx Corp announced that the US Food and Drug Administration (FDA) has approved the company’s Rizafilm VersaFilm new drug application (NDA) for the treatment of acute migraine.
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The Role of Pharmacokinetics in Generic Drugs
Drug Patent Watch
OCTOBER 7, 2024
PK studies help ensure that generic drugs are bioequivalent to their brand-name counterparts, meaning they have similar absorption, distribution, metabolism, and excretion (ADME) profiles. Pharmacokinetics (PK) plays a crucial role in the development and approval of generic drugs.
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CRO Data Integrity Concerns Have Pharma Companies Scrambling to Repeat Bioequivalence Studies
BioSpace
SEPTEMBER 28, 2021
The announcement came following independent FDA analyses of inspections conducted at the two CROs in November 2019.
Samsung Bioepis’ SB12 Soliris® (Eculizumab) Biosimilar Demonstrates PK, PD Bioequivalence in Phase 1 Study
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 → (..)
The Role of Scientific Expertise in Generic Drug Development
Drug Patent Watch
DECEMBER 10, 2024
The Importance of Scientific Expertise Generic drug development involves a deep understanding of the scientific principles underlying drug development, including pharmacology, pharmacokinetics, and bioequivalence. Bioequivalence Studies : Bioequivalence studies are a critical component of generic drug development.
EC approves AstraZeneca’s Calquence tablet formulation for CLL
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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In the News: October Regulatory and Development Updates
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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The Composition and Value of a Portfolio Analysis
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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The drug industry continues to dare regulation
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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Do generics producers have what it takes to tackle complex and specialty drugs?
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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Quality by design with a focus on biosimilars
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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Understanding the Regulatory Environment in Japan for Generic Drug Development
Drug Patent Watch
DECEMBER 30, 2024
The ANDA must demonstrate bioequivalence to the Reference Listed Drug (RLD), which is the original brand-name drug approved for marketing in Japan. Abbreviated New Drug Application (ANDA) : Required for marketing approval of generic drugs. Generic Drug Development To market a generic drug in Japan, an ANDA must be submitted to the PMDA.
A PSA on PSGs: PSG Meetings Are Now Available
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.
Using FDA Product Specific Guidances (PSGs) as a Trigger for Generic Drug Development
Drug Patent Watch
DECEMBER 11, 2024
These guidances serve as a roadmap for companies looking to develop generic versions of brand-name drugs, offering invaluable insights into the FDA’s expectations for demonstrating bioequivalence and ensuring product quality. Understanding FDA Product Specific Guidances Product Specific Guidances are documents issued by the U.S.
The Importance of Regulatory Expertise in Generic Drug Development
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.
Revised Final Guidance on Nitrosamines Offers New Recommendations for Assessment and Control
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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Gelteq IPO: Supporting Gel Technology for Oral Drug Delivery
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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FDA Releases Draft Guidance on Essential Drug Delivery Outputs
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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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis
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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Headache for Zosano as FDA turns down migraine patch
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.
In the News: June 2021 Regulatory and Development Updates
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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When FDA-Approved Generics Fail: Brand Wellbutrin XL Antidepressant is Cheaper from Canada
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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How PK Modeling Can Inform Sample Size Estimation and Dose Selection for Your Product
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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Can a CRL Be Final Agency Action: One Step Closer to Finding Out
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.
Lots of FDA Guidance, But Few Drug Manufacturing “Remote Interactive Evaluations” (We Would Call Them “Virtual Inspections”)
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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Knock, Knock – FDA Issues Guidance on Best Processes and Practices During BIMO Inspections
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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Amphastar Announces Approval for Glucagon for Injection Kit, 1mg
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.
Teva to Present New Data on Once-Daily AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets at the 2023 American Academy of Neurology Annual Meeting
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.
NewAmsterdam’s CETP renaissance gathers pace
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.
How to Identify Branded Drugs with a Low Likelihood of Generic Entry as Targets for In-Licensing
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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TE Codes 101: FDA Guidance Teaches Basics of Therapeutic Equivalence Codes
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.
Jailed pharma exec fined £47m and banned from industry
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.
FDA Knows Its Own Strength—and It Includes Concentration
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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The European Commission Grants Marketing Authorization for VUMERITY® (diroximel fumarate) as Oral Treatment for Relapsing-Remitting Multiple Sclerosis
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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SKYRIZI® (risankizumab-rzaa) Now Available in the U.S. as a Single 150 mg Injection for Adults with Moderate to Severe Plaque Psoriasis
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.
Biosimilars vs. Interchangeable Biological Products: FDA Fact Check
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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CHMP Recommends VUMERITY® (diroximel fumarate) for Approval within the European Union as a Treatment for Relapsing-Remitting MS
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.
The Mesh of the Generics and the Potential of Emerging Therapies in the Smoking Cessation Market
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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TLC Provides Corporate Update at Investor Conference – Dec 18, 2020
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.
Novartis announces NEJM publication of Phase III ASCLEPIOS trials demonstrating superior efficacy of ofatumumab in patients with relapsing multiple sclerosis
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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Cerelle vs Cerazette: Are they really the same?
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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Present Treatments & Hopeful Future Directions for ALS Pharmacotherapies
Worldwide Clinical Trials
MAY 30, 2024
Approval has been based on bioequivalence with the FDA stating that the effectiveness of Radicava ORS is based on a study showing comparable levels of Radicava ORS in the bloodstream to the levels from the IV formulation of Radicava. This is administered according to the same treatment regimen as for the IV infusion.
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