From Specialty Pharmacy News - Although the FDA has long taken a mainly hands-off policy toward laboratory developed tests (LDTs), that is about to change. Responding to growing calls to issue draft guidance — and ignoring other pleas to maintain the status quo — the agency notified Congress on July 31 that it intends to issue such guidance within 60 days. Read more
From Specialty Pharmacy News - Although the FDA has yet to approve a product through the 351(k) biosimilar pathway, multiple follow-on drugs are working their way through the pipeline, noted Kate Keeping, senior director of biosimilars research for BioTrends Research Group at a June 30 webinar sponsored by the company. “The United States is the only developed market to have no biosimilars, but development is ramping up,” Keeping said. As of June, 23 biosimilar products were… Read more
From Drug Benefit News - Marking another key step in the long-awaited arrival of biosimilars to the U.S., Sandoz on July 24 said the FDA accepted biosimilar filgrastim for review. Sandoz, a Novartis Group company, is the first firm to announce a biosimilar filing under the pathway created in the Biologics Price Competition and Innovation Act contained in the health reform law. Read more
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