03:19 , Nov 17, 2017 |  BC Week In Review  |  Company News

CAFC affirms Apotex biosimilars do not infringe Amgen patent

The U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a district court ruling that two biosimilars from Apotex Inc. (Toronto, Ontario) do not infringe a patent held by Amgen Inc. (NASDAQ:AMGN). Amgen sought...
23:16 , Nov 13, 2017 |  BC Extra  |  Company News

CAFC affirms Apotex biosimilars do not infringe Amgen patent

The U.S. Court of Appeals for the Federal Circuit affirmed a district court ruling that two biosimilars from Apotex Inc. (Toronto, Ontario) do not infringe a patent held by Amgen Inc. (NASDAQ:AMGN). Amgen sought a...
20:27 , Sep 15, 2017 |  BC Week In Review  |  Clinical News

FDA accepts Adello's BLA for Neupogen biosimilar

FDA accepted for review a BLA from Adello Biologics LLC (Piscataway, N.J.) for its biosimilar candidate of neutropenia drug Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN). Adello did not disclose the user fee action goal date....
21:17 , Jul 31, 2017 |  BC Extra  |  Company News

Radius Health scores with Express Scripts 2018 formulary

Radius Health Inc. (NASDAQ:RDUS) gained $1.90 to $44.03 Monday after Express Scripts Holding Co. (NASDAQ:ESRX) listed Radius' osteoporosis drug Tymlos abaloparatide-SC as a preferred alternative to Forteo teriparatide from Eli Lilly and Co. (NYSE:LLY). The...
07:00 , Sep 8, 2016 |  BC Extra  |  Company News

Court: Apotex biosimilars don't infringe Amgen patent

A federal judge ruled that two biosimilars from Apotex Inc. (Toronto, Ontario) do not infringe a patent held by Amgen Inc. (NASDAQ:AMGN). Amgen sought a ruling that Apotex's biosimilar versions of neutropenia drugs Neulasta pegfilgrastim...
08:00 , Nov 10, 2014 |  BC Week In Review  |  Company News

Amgen, Novartis biosimilars news

Amgen submitted a Citizen's Petition to FDA asking the agency to require that biosimilar applications include a certification that the applicant will comply with patent resolution protocol of the Biologics Price Competition and Innovation Act...
08:00 , Nov 3, 2014 |  BC Week In Review  |  Company News

Amgen, Novartis biosimilars news

Amgen filed a lawsuit in the U.S. District Court for the Northern District of California alleging that Novartis' Sandoz Inc. generics unit has not followed statutory requirements related to their submission of a BLA to...
02:37 , Oct 31, 2014 |  BC Extra  |  Top Story

Amgen sues Sandoz over filgrastim biosimilar BLA

In the first lawsuit filed by an originator company over a biosimilars application, Amgen Inc. (NASDAQ:AMGN) alleged that the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) has unlawfully refused to follow the patent resolution protocol...
07:00 , Jul 28, 2014 |  BC Week In Review  |  Clinical News

Zarzio regulatory update

Novartis’ Sandoz Inc. generics unit said FDA accepted a BLA for a biosimilar version of neutropenia drug Neupogen filgrastim G-CSF from Amgen Inc. (NASDAQ:AMGN, Thousand Oaks, Calif.). Sandoz is the first company to...
07:00 , Jul 28, 2014 |  BioCentury  |  Regulation

Putting FDA to biosimilars test

Sandoz picked a relatively simple molecule for its first FDA biosimilars application, but the Novartis AG unit is presenting the agency with three tough regulatory challenges. Sandoz is asking FDA to allow it to share...