Legal

Genentech Alleges Infringement by Samsung Bioepis

July 8th 2020

By Skylar Jeremias

Genentech seeks to block the marketing of Samsung Bioepis’ proposed bevacizumab biosimilar, saying the company infringed multiple patents when submitting an FDA approval application.

Higher Court Sides With Amgen in Mvasi Case

July 6th 2020

By Tony Hagen

Article

In upholding a lower court ruling, a federal circuit court has decided that Amgen gave enough notice prior to launching its bevacizumab biosimilar. The court decision has frustrated an attempt by Genentech to block sales of the product.

BPCIA in Crosshairs as Opponents File Arguments With High Court to End Health Law

June 26th 2020

By Tony Hagen

Article

Republican opponents of the Affordable Care Act (ACA), led by the state of Texas, fired opening salvos in the Supreme Court case over the landmark law's constitutionality. If the entire law is thrown out, approval for biosimilars under the Biologics Price Competition and Innovation Act (BPCIA) would disappear, too.

Plaintiffs Suing AbbVie Have Until June 29 to Decide Whether to Continue Class Action

June 22nd 2020

By Allison Inserro

Article

The judge in the Humira case, while noting that the patents have made it nearly impossible for rivals to gain a foothold, said the suit did not constitute a valid antitrust claim.

AAM Makes a Plea to Save the BPCIA

May 27th 2020

By Tony Hagen

Article

Among the briefs filed in defense of the Affordable Care Act and, with it, the Biologics Price Competition and Innovation Act (BPCIA), is one from the Association for Accessible Medicines, which argues the BPCIA is vital to biosimilars market development.

FDA's Drug Approval System Is More Open Than Australia's

May 11th 2020

By Tony Hagen

Article

Australia’s secretive drug approval system gives what some believe is an unfair advantage to rival drug companies.

Amgen Claims Infringement of a Patent That Didn't Exist

May 1st 2020

By Tony Hagen

Article

Trying to carve back its market share for Neupogen, its filgrastim originator product, Amgen is hoping product exclusivity can be backdated.

In Europe, Secondary Patents Can't Stop Biosimilars, Study Says

April 29th 2020

By Deana Ferreri, PhD

Article

European investigators say their analysis of court cases involving innovator monoclonal antibodies suggests secondary patents have generally failed to stop biosimilar competition.

Genentech's Misfire on Kanjinti Creates Opening

April 28th 2020

By Tony Hagen

Article

Taking an abundance of time to file a motion to block Kanjinti from coming to market, Genentech unwittingly may have tipped the scales in favor of biosimilar applicants.

Wong Discusses Strength of Regulatory Actions

April 23rd 2020

By The Center for Biosimilars

Article

Ha Kung Wong, JD, a patent law attorney with Venable of New York, New York, discusses recent regulatory actions to promote biosimilars.