We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results: 1-10 of 84

FDA Approves the First Gene Therapy to Treat an Inherited Disease
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • January 3 2018

On December 19, 2017, FDA approved the gene therapy Luxturna (voretigene neparvovec-rzyl), developed by Spark Therapeutics, to treat children and


2017 Biosimilar Approvals in Europe
  • Patterson Belknap Webb & Tyler LLP
  • European Union
  • December 21 2017

The European biosimilar market has expanded at record pace in 2017. The EMA approved marketing of sixteen biosimilar products referencing seven


US Biosimilar Approvals Soar in 2017
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • December 18 2017

Marketing approval for US biosimilars has taken off in 2017. FDA has approved five biosimilar products this year, increasing the number of approved


Federal Circuit Affirms Apotex Bench Trial Win in Neulasta Biosimilar Suit
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • November 21 2017

On November 13, The Federal Circuit issued a decision affirming a district court judgment that Apotex did not infringe Amgen’s recombinant protein


Amgen and Genentech Break New Ground in Avastin Biosimilar Dispute
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • October 26 2017

Amgen and Genentech have become embroiled in a novel procedural dispute relating to Mvasi, Amgen’s biosimilar of Genentech’s Avastin (bevacizumab). On


Amgen Files Infringement Suit Against Mylan Over Neulasta Biosimilar
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • September 28 2017

Amgen has filed patent infringement claims against Mylan and its subsidiaries over Mylan’s proposed biosimilar version of Neulasta (pegfilgrastim


Following Biosimilar Trial, Jury Awards Amgen $70 Million for Pfizer’s Pre-Approval Infringement of Now-Expired EPO Patent
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • September 25 2017

In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in


FDA Approves First Avastin Biosimilar
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • September 15 2017

FDA announced Thursday that it has approved Mvasi (bevacizumab-awwb), Amgen and Allergan’s biosimilar of Genentech’s Avastin (bevacizumab), a


Third Circuit Holds No Sham Litigation or Unlawful Reverse Payment in Wellbutrin XL Litigation
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • August 25 2017

The Third Circuit recently affirmed the grant of summary judgment to GlaxoSmithKline (“GSK”) in the nearly 10-year-old Wellbutrin XL Antitrust


Coherus Asks Court to Stay BPCIA Litigation After FDA Rejects its Neulasta Biosimilar
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • July 28 2017

Many biosimilar makers have tried and failed to obtain approval of biosimilar versions of Amgen’s Neulasta (pegfilgrastim), a long-acting version of