By Michael J. Alkire, Premier Chief Operating Officer
Members of the Premier alliance are extremely pleased with the Supreme Court ruling in the case of Sandoz v. Amgen, which allows biosimilar manufacturers to provide their 180-day notice of intent to market before they receive their final FDA approval. With this decision, the Supreme Court has effectively closed a competitive loophole that allowed branded companies an additional six months of market exclusivity, and delayed the competitive entrance of biosimilars that have been shown to lower pharmaceutical costs. Given that pharmaceutical prices, particularly for biologics, are increasingly eating up a larger share of the healthcare dollar, this decision is critical to advancing a market that leverages competitive forces to bring down costs.
— Michael J. Alkire, Premier Chief Operating Officer