Bionest

Building a Better Market for Biologics: The US vs. Europe

The advent of generics has dramatically impacted the cost of small molecule drugs following the expiry of the patent protection for the originator therapeutics, with the cost of a small molecule generic often as little as 10% of that of the originator drug. This price difference results from several factors, including lower R&D costs, fewer...

Bionest

The Drug Pricing Blueprint — and Audience Reactions

In May of this year, the Trump White House issued its “Blueprint to Lower Drug Prices” in response to the Administration’s views that excessively high drug prices “burdening the American people” were in part caused by “foreign freeloading” and a system currently rigged “to reward list price increases.”   The policy document, which was open...

Bionest

A New ‘Neulasta’: First Biosimilar Version Gains FDA Approval

In early June, the U.S. Food and Drug Administration (FDA) approved the first biosimilar version of Amgen’s Neulasta (pegfilgrastim), a biologic that is used to reduce the chances of infection in cancer patients whose immune system have been suppressed by chemotherapy. The new biosimilar, developed by Mylan and Biocon, is expected to launch as Fulphila...