Camargo

JULY 8, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The report is a useful read to keep current on a topic of interest at the FDA and in drug development as a whole.

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Development Bioequivalency Gene Expression Drugs 130

Drug Patent Watch

OCTOBER 7, 2024

Pharmacokinetics (PK) plays a crucial role in the development and approval of generic drugs. 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.

Generic Drugs 105

Generic Drugs Bioequivalency Drugs Branding 105

Camargo

DECEMBER 22, 2021

Informed by today’s competitive drug development landscape, as well as by the sponsor’s strategic goals and capabilities, a portfolio analysis involves assessing product concept and differentiation, strategic planning, factoring in unmet patient needs, and estimating timelines and expenses. Biowaiver Eligibility.

Bioequivalency 169

Bioequivalency Production Genotoxicity In-Vivo 169

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. Optimising development and scale-up. Particle distribution. Grittiness.

Production 130

Production Manufacturing Development Bioequivalency 130

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.

Drug Delivery 104

Drug Delivery Drugs Bioequivalency Bioavailability 104

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.

Bioequivalency 130

Bioequivalency Trials Medicine Production 130

World of DTC Marketing

FEBRUARY 21, 2022

didn’t just offer to pay for the drug’s development cost so that the price could be set very low, but it’s about investors who penalized the company stock when they learned that COVID might be on the decline. At this point, one must wonder why the U.S. About those copay cards.

Regulation 218

Regulation Drugs Bioequivalency Vaccine 218

Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. In this article, we will explore the importance of regulatory expertise in generic drug development, highlighting the key challenges and opportunities in this field.

Generic Drugs 52

Generic Drugs Development Bioequivalency Drugs 52

Drug Patent Watch

DECEMBER 12, 2024

Branded drugs, developed through extensive research and clinical trials, often enjoy patent protection for a limited period. The Appeal of In-Licensing In-licensing has emerged as a strategic approach for pharmaceutical companies to expand their product offerings without incurring the high costs and risks associated with drug development.

Licensing 96

Licensing Licensing Branding Drugs 96

Pharmaceutical Technology

OCTOBER 28, 2022

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Dr Amiji says that these harmonisation guidelines help industry understand the necessary requirements for developing pharmaceutical products.

Bioequivalency 130

Bioequivalency Production Contamination Branding 130

Pharmaceutical Technology

JULY 25, 2022

The FDA knows that developing specialty generics, particularly generic injectable products, can be challenging. Drugs with an AB rating meet the required bioequivalence. Supply chain issues also come into play, meaning that owning proprietary API production is an advantage, he says.

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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. As part of its Generic Drug User Fee Amendments of 2022 (“GDUFA III”) Commitment, FDA agreed to expedited development of PSGs.

Bioequivalency 59

Bioequivalency Generic Drugs Packaging In-Vivo 59

Worldwide Clinical Trials

MAY 30, 2024

This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. The shared placebo design is another approach to accelerating drug development in ALS research.

Gene 204

Gene Clinical Trials Clinical Trials Gene Therapy 204

Camargo

FEBRUARY 10, 2021

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. Pharmacokinetics (PK) and bioequivalence (BE) studies serve as the foundation of determining the fate of drug products. that could arise from that same population.

Production 133

Production Bioavailability In-Vivo In-Vitro 133

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. Comments may be submitted by September 30, 2024.

Drug Delivery 105

Drug Delivery Drugs Bioequivalency Production 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.

Compliance 111

Compliance Bioequivalency Cosmetics Regulation 111

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.

Bioequivalency 52

Bioequivalency Drugs Production Manufacturing 52

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. billion, three biosimilar products in development targeting products with a market size of approximately $13.0

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Bioequivalency Production Sales Marketing 52

pharmaphorum

JANUARY 18, 2023

Recently-listed NewAmsterdam is trying to succeed where a number of much larger drugmakers have failed – including Merck & Co , Pfizer, Eli Lilly, and Roche – which have all scrapped CETP development programmes following safety or efficacy issues. Amgen licensed the rights to NewAmsterdam in 2020.

Bioequivalency 59

Bioequivalency Trials Licensing Licensing 59

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.

Bioequivalency 40

Bioequivalency FDA Approval Medicine Bioavailability 40

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.

Bioequivalency 40

Bioequivalency Production Drugs Packaging 40

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 or visit your respective country’s product website. References: 1 National Multiple Sclerosis Society.

FDA Approval 40

FDA Approval Bioequivalency Clinical Trials Clinical Trials 40

XTalks

FEBRUARY 8, 2021

Last year, Biocon Biologics and Mylan announced they’d be seeking interchangeable status for their long-acting insulin product Semglee , developed to be an alternative to Sanofi’s Lantus (insulin glargine). Unlike small-molecule generic drugs, biosimilars do not need to demonstrate bioequivalence to the innovator product.

Production 78

Production Insulin Branding Generic Drugs 78

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.

Production 59

Production Bioequivalency Drugs Containment 59

Delveinsight

FEBRUARY 5, 2021

Here the generics in question are of the world’s leading developer of generics, Teva (and produced by Impax Pharmaceuticals ). 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.

Marketing 52

Marketing FDA Approval Branding Production 52

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

Marketing 52

Marketing Bioequivalency Clinical Trials Clinical Trials 52

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. 2 It affects an estimated 7.5

Bioequivalency 52

Bioequivalency Vaccine Vaccination Medicine 52

The Pharma Data

DECEMBER 17, 2020

With experiences attained in licensing and business development functions from Amgen, Baxter and Johnson & Johnson, Mr. Bliss introduced himself in Mandarin Chinese. Patient enrollment of EXCELLENCE pivotal trial reaches 98%. SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec. About TLC.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Containment 40

The Pharma Data

DECEMBER 27, 2020

The drug is a humanized IgG4 monoclonal antibody that blocks CCR5 and is being developed for COVID-19, HIV and metastatic triple-negative breast cancer. It is being developed for HER2-targeted therapies and in patients with HER2-positive cancers, potentially as a way to overcome tumors that are resistant to existing HER2 therapies.

Trials 52

Trials Antibody Gene Therapy Gene 52

The Pharma Data

SEPTEMBER 26, 2021

Head of Research and Development at Biogen. “We anticipate to advancing Biogen’s portfolio and continuing to figure with the MS community to deal with critical treatment challenges, including people who affect persistence and adherence to medication for this chronic and life-long disease,” said Alfred Sandrock, Jr.,

Clinical Trials 40

Clinical Trials Clinical Trials Bioequivalency Medicine 40

The Pharma Data

AUGUST 5, 2020

About ofatumumab Ofatumumab (OMB157) is a fully human anti-CD20 monoclonal antibody (mAb) in development for RMS that is self-administered by a once-monthly injection, delivered subcutaneously 1,3. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. J Neurol Sci. 2003;206(2):165–71.

Trials 52

Trials Medicine Production Containment 52

FDA Law Blog

JULY 9, 2024

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). Although not required by FDORA, FDA encourages sponsors to consider such additional factors, which may support subgroup analyses, when developing DAP goals.

Clinical Trials 59

Clinical Trials Clinical Trials Development Drugs 59

FDA Law Blog

JANUARY 23, 2023

More recently, in April 2022, the agency issued draft guidance recommending sponsors to develop Diversity Action Plans to improve the enrollment of racial and ethnic populations in clinical trials. Now, FDORA makes these plans mandatory for most drug and device studies.

Trials 59

Trials Clinical Trials Clinical Trials Drugs 59

Drug Patent Watch

JANUARY 22, 2025

The Science Behind Generic Drug Bioequivalence: Separating Fact from Fiction As a healthcare professional or someone simply looking to stay informed, you've likely heard the term "bioequivalence" thrown around when it comes to generic drugs. But what does it really mean, and how does it impact the medications we take?

Bioequivalency 81

Bioequivalency Generic Drugs Drugs Branding 81

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. They offer guidance on formulation development and manufacturing considerations.

Generic Drugs 95

Generic Drugs Production Development Bioequivalency 95

Drug Patent Watch

JANUARY 7, 2025

They’re designed to be bioequivalent, meaning they have the same dosage, strength, route of administration, quality, and intended use as the original brand-name drug. For example, instead of saying “bioequivalent,” you might say “works the same way in the body.” What Are Generic Drugs?

Generic Drugs 89

Generic Drugs Drugs Branding Bioequivalency 89

The Pharma Data

MAY 3, 2021

Korea To Toughen Co-Bioequivalence Study System Amid Generic Quality Issue ( Pink Sheet ). Sandoz confirms late-stage clinical development plans for proposed biosimilar aflibercept, a key ophthalmology medicine ( Press ). UK Could Become ‘World Leader’ On Biosimilar Regulation ( Pink Sheet ).

Gene Therapy 52

Gene Therapy Vaccination Vaccine Bioequivalency 52