Bioequivalency, Branding and Development - Clinical Research Informer

How to Identify Branded Drugs with a Low Likelihood of Generic Entry as Targets for In-Licensing

Drug Patent Watch

DECEMBER 12, 2024

Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. Branded drugs, developed through extensive research and clinical trials, often enjoy patent protection for a limited period.

Licensing

Licensing Licensing Branding Drugs

Innovative Approaches to Generic Drug Development: Case Studies

Drug Patent Watch

JANUARY 14, 2025

Why Generic Drugs Matter Generic drugs are the Robin Hoods of the pharmaceutical world, stealing from the rich (brand-name drugs) and giving to the poor (our wallets). They offer the same therapeutic benefits as their brand-name counterparts but at a fraction of the cost. But how do companies develop these cost-effective alternatives?

Generic Drugs

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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

DECEMBER 30, 2024

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Generic Drug Development To market a generic drug in Japan, an ANDA must be submitted to the PMDA. Conclusion The regulatory environment in Japan for generic drug development is complex and evolving.

Generic Drugs

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The Role of Scientific Expertise in Generic Drug Development

Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that involves not only scientific and medical expertise but also adherence to strict legal and ethical standards. Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts.

Generic Drugs

Generic Drugs Bioequivalency Development Drugs

The Role of Pharmacokinetics in Generic Drugs

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

Generic Drugs Bioequivalency Drugs Branding

The drug industry continues to dare regulation

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

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Do generics producers have what it takes to tackle complex and specialty drugs?

Pharmaceutical Technology

JULY 25, 2022

Unlike biosimilars, it is simpler for small molecule specialty generics to establish equivalence to their branded forms, explains Vasquez. The FDA knows that developing specialty generics, particularly generic injectable products, can be challenging. There are significant rebates associated with the sort of branded versions here.”.

Drugs

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Quality by design with a focus on biosimilars

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

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

Bioequivalency

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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

FEBRUARY 8, 2021

Like generic forms of synthetic pharmaceuticals, biosimilars have the advantage of being less costly compared to their branded counterparts. Unlike small-molecule generic drugs, biosimilars do not need to demonstrate bioequivalence to the innovator product.

Production

Production Insulin Branding Generic Drugs

The Mesh of the Generics and the Potential of Emerging Therapies in the Smoking Cessation Market

Delveinsight

FEBRUARY 5, 2021

Whenever the branded drugs go off-the-market, it paves the way for the entry of generics in the market. Generic medications are the same as the original branded ones, but cheaper. Here the generics in question are of the world’s leading developer of generics, Teva (and produced by Impax Pharmaceuticals ). Generics in the Market.

Marketing

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The Science Behind Generic Drug Bioequivalence

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

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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. They offer guidance on formulation development and manufacturing considerations.

Generic Drugs

Generic Drugs Production Development Bioequivalency

Educating Patients about Generic Drugs: Strategies for Success

Drug Patent Watch

JANUARY 7, 2025

Generic drugs are pharmaceutical products that contain the same active ingredients as their brand-name counterparts. 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.

Generic Drugs

Generic Drugs Drugs Branding Bioequivalency

Clinical Research Informer

How to Identify Branded Drugs with a Low Likelihood of Generic Entry as Targets for In-Licensing

Innovative Approaches to Generic Drug Development: Case Studies

Trending Sources

Understanding the Regulatory Environment in Japan for Generic Drug Development

The Role of Scientific Expertise in Generic Drug Development

The Role of Pharmacokinetics in Generic Drugs

The drug industry continues to dare regulation

Do generics producers have what it takes to tackle complex and specialty drugs?

Quality by design with a focus on biosimilars

Amphastar Announces Approval for Glucagon for Injection Kit, 1mg

Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

The Mesh of the Generics and the Potential of Emerging Therapies in the Smoking Cessation Market

The Science Behind Generic Drug Bioequivalence

Using FDA Product Specific Guidances (PSGs) as a Trigger for Generic Drug Development

Educating Patients about Generic Drugs: Strategies for Success

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