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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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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FDA Law Blog

JULY 6, 2021

The CRL was issued on July 21, 2020 on Nostrum’s Prior Approval Supplement ANDA seeking approval to move its manufacturing facilities.

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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

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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Camargo

DECEMBER 13, 2021

A 351(k) application is a BLA process submitted by a manufacturer to get a product reviewed as a biosimilar or interchangeable, which is considered to be “highly similar” to an FDA-licensed reference product. The role of pharmacometrics for biosimilars is no less significant than for biologics.

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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

JULY 25, 2022

With decreasing margins on the horizon, pharma manufacturers have long shown an interest in specialty generics, which is only expected to rise in the future. Despite this, specialty generics are expected to be the domain of a handful of companies with the necessary manufacturing capabilities and legal backing needed for entering the market.

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XTalks

FEBRUARY 8, 2021

Crucially, biosimilars manufacturers must also demonstrate that their product’s safety and efficacy profile won’t go down if a patient switches back and forth between the biosimilar and the reference product during the course of treatment. Because most biologics are mixtures of variants, they really can’t be copied exactly.”.

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Druggist

MARCH 25, 2021

Although the active ingredient is the same, there are differences in non-active components (the core of the tablet and coating), which reflect both pills’ manufacturing process. As with other drugs, once a patent expires, other manufactures start to produce generic or new brands of the same pill (desogestrel). References: .

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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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The Pharma Data

DECEMBER 17, 2020

In addition, TLC is preparing for scale-up production of TLC590, as for complex lipid products, the manufacturing process and batch size used in pivotal clinical trials and New Drug Application submission must be the same as future commercial batches.

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Pharmaceutical Technology

JANUARY 6, 2023

The preparation of a semi-solid dosage form – from formulation and development, to scale-up, commercial manufacturing, and packaging – should ideally take place under one roof in a contiguous, end-to-end workflow to avoid unnecessary equipment and process changes. In vitro release testing to demonstrate bioequivalence.

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The Pharma Data

MAY 3, 2021

India’s vaccine shortage will last months, biggest manufacturer warns ( FT ). Korea To Toughen Co-Bioequivalence Study System Amid Generic Quality Issue ( Pink Sheet ). Korea To Toughen Co-Bioequivalence Study System Amid Generic Quality Issue ( Pink Sheet ). Coronavirus Pandemic.

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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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