Biosimilars/Biobetters - BioPharm International



GPhA Issues Statement on Generic Drug Costs

November 20, 2014

Ralph G. Neas, president and CEO of the Generic Pharmaceutical Association, requests that Congress get involved in the support of a more competitive drug market.

FDA Practices Discourage Biologic Market Competition, Says PCMA White Paper

November 19, 2014

A new report from The Pharmaceutical Care Management Association alleges that FDA hinders competition in the pharmaceutical industry and influences how a drug's price is calculated.

Amgen Requests FDA Require Certification of Compliance with Biosimilar Pathway

November 4, 2014

Amgen wants the regulatory agency to ensure biosimilar applicants follow the rules of the patent dispute resolution process delineated by the BPCIA.

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FDA Releases Draft Guidance on Biosimilarity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Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.



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