Biosimilars/Biobetters - BioPharm International

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Biosimilars/Biobetters

Industry Stakeholders Tackle the Use of Biological Qualifiers at WHO Naming Session

October 16, 2014

Many European biosimilar groups argue that biological qualifiers should not be implemented in countries where the brand name or INN of a drug is already well established.

Amgen Reports Positive Phase III Results for Biosimilar of Humira

October 9, 2014

ABP 501, a biosimilar candidate for Humira, was shown to have a immunogenicity and efficacy profile comparable to that of the innovator product.

USP Supports WHO Biologics Naming Proposal

September 25, 2014

USP expresses its support for a consensus-based global approach to the naming of biologics.

FDA Urged to Preserve Biosimilar Naming Conventions

July 2, 2014

Several groups, including pharmacies, call on FDA to preserve accepted International Nonproprietary Name conventions for biosimilars.

Research Firm Predicts Negative Impact of Biosimilars

June 12, 2014

A new report from GlobalData states that biosimilars will overtake the market share after 2019.

FDA Releases Draft Guidance on Biosimilarity

May 14, 2014

Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.

Monoclonal Antibodies Key to Unlocking the Biosimilars Market

April 1, 2014

The approval and acceptance of monoclonal antibody biosimilars is necessary if the biosimilars market is to experience real growth.

EMA Collaborates with HTA Assessment Networks

February 1, 2014

High technology assessments are having an impact on biosimilars development in Europe.

Advances in UPLC Techniques and Column Chemistry Aid the Confirmation of Biosimilarity

February 1, 2014

Automated sample handling, advanced glycan analysis and specially designed columns are helping biosimilar manufacturers speed up confirmation of the biosimilarity of their products.

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