By Anna Rose Welch, Editor, Biosimilar Development
Complex drugs (including biologics) were once considered a black box filled with inexplicable structures and incomprehensible variabilities. However, as Momenta’s Craig Wheeler describes, when it comes to tackling the complexity of biosimilars, it comes down to having the “right lens” to succeed scientifically and commercially.
By Gary Levin and Ron Kern, BakerHostetler
The Federal Circuit’s recent decision to not rehear the Amgen Inc. v. Sandoz, Inc. case leaves open several important issues under the BPCIA. Whether or not the Supreme Court reviews the issues from the final Federal Circuit decision, other important questions about the BPCIA remain to be addressed.
An exciting trend in drug delivery is underway: the movement toward smaller, smarter, wirelessly connected electronic devices that allow patient-administered therapy. Inspired by the technological advancements driving the consumer electronics market, new methods for drug delivery show great promise for all stakeholders.