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FDA Withdraws Draft Guidance on Evaluating Analytical Similarity Following Industry Criticism
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • June 27 2018

Analytical studies to demonstrate that a biosimilar is highly similar to its reference product are central to the biosimilar development and approval


Senator Hatch’s New Legislation Would Eliminate IPR Challenges by Generics and Biosimilar Makers
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • June 18 2018

Generics and biosimilar makers have increasingly used inter partes reviews (“IPRs”), proceedings made possible by the America Invents Act, to


FDA Approves Pfizer’s EPO Biosimilar
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • May 16 2018

Yesterday, Pfizer announced that FDA had approved Retacrit (epoetin alfa-epbx), a biosimilar of Amgen’s Epogen and Johnson & Johnson’s Procrit


Amgen v. Adello: A Blind Biosimilar Infringement Lawsuit
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • April 9 2018

Last month, Amgen sued Adello Biologics, a US-based biosimilar maker, for patent infringement under the Biologics Price Competition and Innovation Act


Win or Go Home? Standing to Appeal PTAB Decisions Upholding Patentability to the Federal Circuit Before Submitting a Biosimilar Marketing Application
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • April 6 2018

Biosimilar developers have been aggressive in filing petitions for inter partes reviews (IPRs) of biologics patents before the Patent Trial and Appeal


FDA Authorizes First Direct-to-Consumer Test for BRCA Gene Mutations
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • March 22 2018

On March 6, 2018, the U.S. Food and Drug Administration (“FDA”) authorized, with special controls, the first direct-to-consumer test to detect the


PTAB Holds Indian Tribes Don’t Offer an Out from IPR
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • March 9 2018

In a highly anticipated decision on the Saint Regis Mohawk Tribe’s motion to terminate inter partes review proceedings, the Patent Trial and Appeal


Claims Against Sanofi for Improper Orange Book Listings and Sham Litigation Dismissed
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • January 22 2018

On January 10, 2018, in In re Lantus Direct Purchaser Antitrust Litig., the District Court for the District of Massachusetts dismissed the antitrust


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