Category Archives: Biologics

Public Meeting on Biosimilars Scheduled for November – Questions Posed by FDA

The FDA has finally scheduled a public meeting to solicit input on the regulatory pathway that is being developed for the approval of biosimilars.  The meeting is set for November 2-3 and will be held at FDA's facility in Silver … Continue reading

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Insight into FDA’s Thinking on a Biosimilar Regulatory Pathway?

Today Teva Pharmaceuticals announced the receipt of a Complete Response Letter from the FDA for their Biological Licence Application (BLA) for Neutroval.  Neutroval is a treatment to reduce the duration of severe neutropenia and the incidence of febrile neutropenia in … Continue reading

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With a Untitled Letter, Does FDA Set New Policy on Stem Cell Use in the United States?

Here is a newsbreaker I think. Stem cells hold a great deal of promise in research and clinical trials are underway around the world to make that promise a reality.  However, many entrepreneurial efforts have been underway to use stem … Continue reading

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Turning Down the Pipeline on Biotechnology

On the Ides of March, Genetic Engineering and Biotechnology News (GEN) published an article by Ronald A. Rader, President of the Biotechnology Information Institute that provided an overview of the product approval rate focusing solely on biologics.  For a long … Continue reading

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Immunogenicity and Follow-on-Biologics

This week, the FDA issued a non-approvable letter to Momenta Pharmaceuticals as outlined in a press release from the company.   The approvable letter was issued to Momenta and its partner, Sandoz, Inc, which is a generics manufacturing division of Novartis.  … Continue reading

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