Legal

Pfizer Reports Continued Weakness for Enbrel in Europe

July 28th 2020

By Tony Hagen

While Amgen fends off etanercept biosimilar competition in the United States, Pfizer said it is facing a mounting battle against biosimilar competition in European and other markets.

IP Attorneys Propose a New Biosimilar Pathway in Case of ACA Repeal

July 25th 2020

By Kevin M. Nelson

Genentech and Amgen Cease Fire on Biosimilar Litigation

July 9th 2020

By Tony Hagen

In court filings this week, Genentech and Amgen laid to rest their long-running dispute over the marketing of bevacizumab and trastuzumab biosimilars that challenged Genentech's dominance of the market for those products.

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

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

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

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

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

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

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