Leveraging Quality Attributes to Increase Supply of Biosimilars

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Biosimilars

Biosimilars hold great promise to help increase availability of quality biologic medicines because they can be approved through an abbreviated regulatory pathway and have the potential to provide more cost-effective treatment choices for patients of conditions ranging from diabetes to cancer.

To support biosimilar development, USP is prioritizing the ongoing development of state-of-the-art analytical tools to accelerate the advancement of biologics and biosimilars, supporting continuous innovation and access to the supply of quality medicines. USP also offers unique solutions to accelerate biosimilar development, including a variety of materials and validated methods for characterization designed to streamline the process, making it more efficient and cost-effective.

USP Standards build trust in Biologics and Biosimilars

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Pharma News Intelligence: Developing Quality Assurance Standards for Biologics, Biosimilars 

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predicting drug shortages

Evolving regulatory frameworks for Biosimilars

Regulatory agencies and industry recognize that opportunities may exist to improve the efficiency of biosimilar product development and are exploring approaches to refine the biosimilar regulatory process to focus on more analytical studies and functional assays. This focus has the potential to decrease the financial burden on biosimilar sponsors and reduce the time to market.

mAbs Analytical Guide

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Maximize Bioassay Success Using USP Standards 

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USP standards

Supporting Biosimilars Manufacturing

When compared to conventional medicine modalities, manufacturing biologic drugs requires more analytical and functional data to ensure patient safety, determine purity, and confirm potency and establish content. USP has existing standards for many biological products with well-defined attributes and is leveraging this expertise to advance methods for establishing biological drug content and potency. The use of USP standards and solutions supports regulatory confidence in methods used and allows biologic and biosimilar manufacturers to operate with a high level of certainty and confidence throughout the drug development and approval process.

U.S. Pharmacopeia Awarded FDA Funding to Create a Multi-Attribute Method (MAM) Knowledge Base

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pharmaceutical manufacturing

Increasing Availability of Biosimilars for Patients

The field of biologics is vast and growing, with tremendous potential to improve patients’ lives and public health. For biologics to reach their full potential, guidelines, best practices and standards are essential to help set expectations for quality, reduce potential risks, accelerate regulatory approvals and build public trust.

Biosimilars: Are they the same quality?

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Do Standards Matter? What is Their Value?

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Biologics and biosimilars - the basics

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Leader in Standards for Medicine Quality

USP, with a rich 200-year legacy as the leader in standards for medicine quality, remains an independent and agile organization dedicated to the innovation and advancement of safe and effective biologic therapies.