Try our Advanced Search for more refined results

Amgen Inc. v. Sandoz Inc.

  1. September 03, 2015

    Sandoz Launches First Biosimilar At 15% Discount

    Sandoz Inc. on Thursday began U.S. sales of anti-infection biosimilar Zarxio, offering a 15 percent discount on Amgen Inc.'s Neupogen in a milestone for efforts to rein in sky-high spending on specialty prescription drugs.

  2. September 02, 2015

    Amgen Can't Block Sandoz Biosimilar At Fed. Circ.

    A divided Federal Circuit on Wednesday rejected Amgen Inc.'s bid to block sales of Sandoz Inc.'s biosimilar Zarxio during continued litigation between the companies, clearing the way for the first biosimilar approved under the Biologics Price Competition and Innovation Act.

  3. August 27, 2015

    Amgen Wants Biosimilar Halted For Full Fed. Circ. Review

    Amgen Inc. implored the Federal Circuit on Wednesday to halt the impending release of Sandoz Inc.'s biosimilar Zarxio until a call is made on Amgen's bid for en banc reconsideration of a panel ruling that sharing information was optional under the Affordable Care Act's approval pathway for biosimilars.

  4. August 26, 2015

    Janssen, Celltrion Brawl Over Fed. Circ. Biosimilar Ruling

    Janssen Biotech Inc. and Celltrion Inc. are squaring off in Massachusetts federal court with competing views of a recent Federal Circuit interpretation of the Biologics Price Competition and Innovation Act, debating whether it made advance-notice of biosimilar marketing mandatory in all circumstances.

  5. August 20, 2015

    Amgen, Sandoz Urge Fed. Circ. To Revisit Biosimilar Ruling

    Amgen Inc. and Sandoz Inc. on Thursday asked the full Federal Circuit to revisit a fractured panel decision on key elements of the Affordable Care Act's approval pathway for biosimilars, arguing in competing petitions that information-sharing and advance-notice provisions were interpreted incorrectly.

  6. July 21, 2015

    5 Takeaways After Fed. Circ. Amgen-Sandoz Ruling

    The Federal Circuit's first interpretation of key provisions in the Biologics Price Competition and Innovation Act contained vague statements that clouded the ruling's impact on biosimilars and featured stark divisions that raised the odds of review by the full court. Here are five issues attorneys should watch in the aftermath of Amgen Inc. v. Sandoz Inc.

  7. July 21, 2015

    Fed. Circ. Amgen-Sandoz Ruling Extends Biologics Exclusivity

    The Federal Circuit on Tuesday partly reversed Sandoz Inc.'s victory over Amgen Inc. in a major battle over requirements of the Affordable Care Act's biosimilars pathway, interpreting an advance-notice provision in a way that effectively extends exclusivity for brand-name biologics by six months.

  8. July 16, 2015

    Patent Cases To Watch In The 2nd Half Of 2015

    Two en banc Federal Circuit cases — one to address whether laches is a viable defense in patent cases and another reconsidering precedent that sales outside the U.S. do not exhaust patent rights — top the list of patent cases that attorneys say they'll be watching for in the second half of the year.

  9. July 06, 2015

    Life Sciences Cases To Watch In The 2nd Half Of 2015

    The pharmaceutical industry is poised for important court developments involving off-label marketing, biosimilars exclusivity, False Claims Act liability and the 340B drug-discount program. Here are four cases that attorneys will be tracking closely in the second half of 2015.

  10. June 03, 2015

    Amgen Says ACA Requires Sandoz To Disclose Biosimilar Info

    Amgen Inc. urged a Federal Circuit panel Wednesday to relight a lawsuit over rival Sandoz Inc.'s refusal to reveal information about its copycat version of Amgen's blockbuster anti-infection drug Neupogen, saying such a move is required by the new biosimilar regime of the Affordable Care Act.