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Useful
resources

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Downloadable
resources

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Video
resources

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FAQs

Downloadable Resources

Download any of our helpful Amneal Biosciences resources below.

For Pharmacy Directors/Providers:

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The Amneal Biosciences Portfolio

Explore the expanding
treatment offerings from
Amneal Biosciences.

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505(b)(2) Overview

Learn more about the
505(b)(2) drug approval
pathway.

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PATHways Provider Brochure

Learn more about how the PATHways program can help you and your practice stay on track toward offering patients accessible treatment.

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PATHways Enrollment Form (English)

Enroll your patients in
Amneal PATHways®.

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PATHways Enrollment Form (Spanish)

Enroll your patients in
Amneal PATHways®.

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For Patients:

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Amneal PATHways® Patient Support Program Guide

This guide can help you learn about a range of resources and services designed to help you start and stay on treatment.

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Videos

Hear from Amneal leaders and tour manufacturing facilities.

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Amneal Biosciences Team Inspired by Family & Loved Ones

Hear personal stories from Amneal Biosciences employees about how their experiences with cancer have motivated them to make a difference through the work they do.

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Voices of Leadership:
Chirag and Chintu

Discover how the founders of Amneal grew from humble beginnings to build a sophisticated affordable medicines company.

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Investing in New Technologies

Go inside the manufacturing facilities to see the latest developments in pharmaceutical creation, including new automation capabilities.

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Our Founders

See how a family business became a pharmaceutical powerhouse and is growing to be a leader in innovative, affordable medicines—while retaining its foundational family values.

Frequently Asked Questions

Get answers to frequently asked questions.

Biologics (including biosimilar medicines) come from living organisms, such as living cells that have been modified using biotechnology to produce the active substance of biological medicine. Available biologics include hormones such as insulin, growth factors, and monoclonal antibodies to treat several diseases.

A biosimilar is highly similar to and has no clinically meaningful differences in safety, purity, and potency (safety and effectiveness) from an existing FDA-approved reference product. The reference product is the single biological product, already approved by the FDA, against which a proposed biosimilar product is compared.

A biosimilar is a biologic that is highly similar to another biologic that is already FDA-approved.

A generic medicine is a drug created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as the brand-name medicine. In other words, you can take a generic medicine as an equal substitute for its brand-name counterpart.

All FDA-approved biologics—including reference, biosimilar, and evolved—biologics undergo rigorous evaluation so that healthcare providers and patients can be assured of the efficacy, safety, and quality of these products. Like any approved medicine, biosimilar medicines can be expected to be safe and effective treatment options when used appropriately in their approved indications. As with any treatment, it is essential to have a thorough conversation with your prescribing doctor about all the available therapeutic options, their safety, benefits and risks, and the differences between the medicines before deciding.

As explained by the FDA, biosimilars and generic drugs are versions of brand-name drugs and may offer more affordable treatment options to patients. Biosimilars and generics are each approved through different abbreviated pathways that avoid duplicating costly clinical trials. But biosimilars are not generics, and there are important differences between biosimilars and generic drugs. For example, the active ingredients of generic drugs are the same as those of brand-name drugs. In addition, the manufacturer of a generic drug must demonstrate that the generic is bioequivalent to the brand-name drug. Unlike traditional small-molecule medications, which have standard production methods and well-defined structures, biological products have a sophisticated manufacturing process that involves the use of living cell cultures. This process can result in heterogeneous products with slight variations in manufacturing.

Several diseases can be treated with biologics. However, the patient’s access to this type of medicine can be limited due to the complexity of manufacturing and high cost. Biosimilar medicines are an effective and safe option for a given treatment and often available at lower prices.

As a similar product, it is possible to switch from a reference medicine to a biosimilar medicine, and this is a growing practice worldwide. Any decision on switching should be taken by your doctor in consultation with you and take into account any policies that your country might have regarding the use of biological medicines. For questions related to switching from one biological medicine to another, patients should speak to their doctor, pharmacist, or specialist nurse.
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