Legal

With the Future of the ACA in Question, Are US Biosimilars at Risk?

December 19th 2018

By Kelly Davio

Article

While many stakeholders are concerned most immediately about how a recent ruling on the Affordable Care Act (ACA) could affect US patients’ healthcare options and coverage for pre-existing conditions, the biosimilars industry is also concerned about the future of one key feature of the ACA that keenly impacts the biosimilars landscape: the Biologics Price Competition and Innovation Act.

Republican Lawmakers Introduce Bill to Limit IPRs by Generic and Biosimilar Developers

December 18th 2018

By Kelly Davio

Article

Last week, Republicans in the House of Representatives and in the Senate introduced legislation that would restrict generic and biosimilar developers from challenging patents on reference drugs using the inter partes review (IPR) process.

Court Denies J&J's Motion to Dismiss in Walgreen and Kroger Antitrust Suit

December 17th 2018

By Samantha DiGrande

Article

Johnson and Johnson (J&J) recently filed a motion to dismiss in the antitrust claim brought against the company by Walgreen and Kroger in regard to sales of J&J’s reference infliximab product, Remicade. In early December, the District Court for the Eastern District of Pennsylvania denied the motion.

Genentech and Pfizer Reach Settlement Over Biosimilar Trastuzumab

December 12th 2018

By Samantha DiGrande

Article

Recently, plaintiff Genentech and defendant Pfizer filed a collective stipulation and proposed order of dismissal of a patent infringement lawsuit over Genentech’s reference trastuzumab product, Herceptin.

Genentech's Civil Suit Against JHL Alleges Proof of Criminal Theft of Trade Secrets

December 8th 2018

By Samantha DiGrande

Article

The complaint includes a screenshot of Xanthe Lam’s Genentech-issued computer, which shows a folder titled “JHL” that contained subfolders, 4 of which were named for Genentech medicines for which JHL was in the process of developing a biosimilar.

Experts Discuss BPCIA Litigation Confusion, Differences Between IPRs and PGRs

November 15th 2018

By Samantha DiGrande

Article

Experts from Venable, Alkermes, and Novartis provide updates to the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and explain the differences between inter partes review (IPR) and post grant review (PGR) litigation.

Momenta Becomes the Latest to Settle With AbbVie Over Humira

November 7th 2018

By Kelly Davio

Article

Momenta Pharmaceuticals announced yesterday that it has reached a settlement with Humira-maker AbbVie over a proposed biosimilar adalimumab, M923.

Eye on Pharma: Celltrion Wins Japanese Trastuzumab Case

November 6th 2018

By The Center for Biosimilars Staff

Article

Republic of Korea-based Celltrion has won a court decision that declared patents on Roche’s Herceptin invalid in Japan.

Amgen Files Cross-Appeal in Ongoing Battle Over Epoetin Alfa

November 5th 2018

By Samantha DiGrande

Article

Amgen filed a cross appeal in this long-running case on October 15, 2018. The appeal challenges, among other things, the district court’s previous judgement that Hospira had not infringed on another patent named in the original suit, US Patent Number 5,756,349, which covers the production of erythropoietin.

Fresenius Kabi Strikes Deal With AbbVie Over Humira

October 19th 2018

By Kelly Davio

Article

Fresenius Kabi has become the latest biosimilar developer to enter into an agreement with Humira maker AbbVie over a biosimilar adalimumab product, MSB11022.