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 in U.S. 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
From Drug Benefit News - Although CMS dropped its previous proposal to significantly expand medication therapy management (MTM) from the final Medicare Advantage (MA) and Part D rule issued in May, the new plan marketing guidelines released a month later appear to encourage more widespread use of those programs without mandating them. Read more
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