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Reintroduction of key legislation presented late last year that would establish a clear and scientifically sound pathway for the approval of follow-on biologics would save the federal government about $14 billion in Medicare costs over the next decade, according to a new report by the Pharmaceutical Care Management Association (PCMA).
A European generic trade group expressed doubts over the validity of a new briefing report released by the International Alliance of Patients’ Organizations (IAPO), saying it fails to clearly address the science behind manufacturing a biosimilar, or follow-on biologic.
A European generic trade group expressed doubts over the validity of a new briefing report released early this week by the International Alliance of Patients’ Organizations (IAPO), saying it fails to clearly address the science behind manufacturing a biosimilar, or follow-on biologic.
With about $16 billion in biologic drug patents set to expire next year and the dramatic shift in the political climate on Capitol Hill, a clear pathway for FDA approval of follow-on biologics may be inching closer to becoming a reality, generic industry experts say.
The FDA’s Center for Biologics Evaluation and Research (CBER) has issued a guidance on how manufacturers of biologic products should submit their lot release protocols in electronic format to CBER’s Product Release Branch.
A company making cancer treatments is disputing a warning letter from the FDA that claims the firm’s manufacturing process falls under its regulations, but a former FDA official says the company has little chance of prevailing.
Sen. Hillary Clinton (D-N.Y.) wants the FDA’s Office of Generic Drugs (OGD) to turn over two biologic product guidances it allegedly drafted four years ago, the senator told the head of OGD at a hearing on Capitol Hill July 20.
Recognizing that industry interest in using nanotechnology in drug development and delivery is on the rise, the FDA will hold a public workshop in mid-October to learn about products under development in drugs and biologics, as well as other areas.