As of January 2018, the Food and Drug Administration (FDA) has approved nine biosimilars—highly similar copies of expensive biologic drugs used to treat cancer and other rare diseases—but only three ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

Natalie Rahhal analyses the issues at stake when the US Supreme Court hears the biosimilars dispute between Sandoz and Amgen later this year The Supreme Court granted cert for the cross-petitions of ...

Please provide your email address to receive an email when new articles are posted on . Despite their much-touted potential to drastically lower the cost of pricey biologics and improve care for ...

All nine justices of the US Supreme Court gathered Wednesday to hear oral arguments from the lawyers of Novartis subsidiary Sandoz and Amgen, who took sides on what's known as the biosimilar "patent ...

Abbvie suing Amgen over its efforts to launch a Humira biosimilar is the first instance of parties not agreeing on which patents to be litigated under the BPCIA. The case poses the question of whether ...

The Court’s Sandoz v. Amgen decision gutted a statute that had been carefully crafted to facilitate timely resolution of patent disputes and avoid delaying market entry of biosimilar products. In ...