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Amgen announced the submission of a BLA with the FDA for ABP 501.

Amgen's Biosimilar BLA For ABP 501 Submitted To FDA

USP responds to FDA's draft guidance on the naming of biological products.

USP Submits Comments to FDA on Biologics Naming Guidance

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Despite considerable investment by biotech manufacturers in developing competitive biologics for the US market, gaining FDA approval of these products has turned out to be a slow and complex process.

Biosimilar Development Continues to Challenge FDA and Industry

In testifying before Congress on FDA regulation of long-awaited biosimilars, Janet Woodcock emphasized the importance of ensuring that the evaluation of new therapies is based on sound science.

FDA Promotes Its Scientific Mission

Manufacturers challenge details in new policies designed to promote access to important therapies.

FDA Faces Controversy Over Quality Metrics and Biosimilars

Growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.

Biosimilars and Follow-on-Biologics Market to Hit $35 Billion Globally by 2020

The EMA, FDA, and EC met to plan collaboration on pharmaceutical drug development and evaluation.

FDA and EU Regulators Strategize Future Collaboration

Stephen Wicks, PhD, is the scientific regulatory policy and intelligence officer of the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe, Stephen.WICKS@edqm.eu. EDQM is a leading organization that protects public health and amongst other things is responsible for the European Pharmacopoeia.

The European Pharmacopoeia addresses the need for monographs for biologicals to keep pace with recent analytical technology advances.

Keeping Up with Biologics Advances

Eight physician groups wrote to the commissioner of FDA to stress the importance of transparency in biosimilar labeling to decrease prescribing risks.

Physician Groups Band Together on Labeling of Biosimilars

The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.

Manufacturing, Biosimilars and Biobetters