Posted in:Legal Litigation Spotlight: The Apotex Filgrastim (Neupogen®) and Pegfilgrastim (Neulasta®) Litigation By Rachel M. Echols May 10, 2017 Comments are off Introduction and Background The Apotex filgrastim/pegfilgrastim biosimilar litigation was the first biosimilar litigation where the... Read more Tagged with: Amgen, Amgen v. Apotex, Apotex, BPCIA, District Court, Featured, Federal Circuit, filgrastim, Legal, Litigation, Litigation Spotlight, Neulasta®, Neupogen®, Notice, Notice Requirement, Patent Dance, pegfilgrastim http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:Legal Litigation Spotlight: The Infliximab (Remicade®) Litigation By Daniel McCallum April 19, 2017 Comments are off Editors’ Note: Although the BPCIA was enacted seven years ago, to date, only four biosimilar products have been approved by the FDA, and... Read more Tagged with: BPCIA, Celltrion, District Court, Featured, Federal Court, Hospira, Inflectra®, Infliximab, Janssen, Janssen v. Celltrion, Legal, Litigation, Litigation Spotlight, Notice Requirement, Patent Dance, Pfizer, Remicade® http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:Regulatory FDA Issues Draft Guidance on Demonstrating Interchangeability By Seth Cockrum January 20, 2017 Comments are off Introduction The Biologics Price Competition and Innovation Act (“BPCIA”) created an abbreviated approval pathway for biological... Read more Tagged with: BPCIA, FDA, Featured, Guidance, Interchangeability, Labeling, Regulatory http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:Regulatory FDA Issues Final Guidance on Non-Proprietary Naming of Biological Products By Rachel M. Echols January 15, 2017 Comments are off On January 12, 2017, FDA released its long-awaited final guidance on naming of biologics and biosimilars, entitled “Nonproprietary Naming... Read more Tagged with: FDA, Featured, Guidance, Labeling, Naming, Regulatory http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus