Legal

Trust, Planning Key to a Successful Biosimilar Launch, Panelists Say

January 24th 2020

By Tony Hagen

Panelists at the 2020 Specialty Therapies and Biosimilars Congress discussed the strategies needed to get biosimilars to market and overcome obstacles by originator product manufacturers.

Biosimilar Makers Must Plan for Originator Firms Gaming the Patent System, Panel Says

January 22nd 2020

By Tony Hagen

It’s important to keep in mind the successive patents that can be filed to keep an original product in a position of market dominance, and drug descriptions in biologic license applications can be written cleverly to achieve this aim, according to a panelist speaking at the Specialty Therapies and Biosimilars Conference, happening January 22-24, 2020, in Miami, Florida.

US Biosimilar Launches, Stymied by Manufacturer Opposition, Continue to Struggle, Analysis Finds

January 14th 2020

By Tony Hagen

In the United States, recent analyses show that biosimilars achieved just 9%, or $91 million, of the $1 billion in cost savings that the Congressional Budget Office projected 10 years ago.

The Top 5 Biosimilars Articles for the Week of January 6

January 11th 2020

The Center for Biosimilars® recaps the top stories for the week of January 6.

Lobbying Group Appeals Decision Allowing California Pay-for-Delay Law to Take Effect

January 9th 2020

By The Center for Biosimilars Staff

The law made California the first state to bar pay-for-delay pharmaceutical agreements by making them presumptively anticompetitive if the nonreference drug maker receives anything of value from the other company.

"Not So Different": Goodwin Attorneys Give a Look at Biosimilar Litigation

January 5th 2020

In the past decade of experience with the Biologics Price Competition and Innovation Act, a number of questions about the biosimilar pathway have been resolved through litigation. This week on the podcast, we're speaking with attorneys Robert Cerwinski, JD, and Alexandra Valenti, JD, both of whom are partners at Goodwin, about experience with litigation, the road ahead for biosimilars, and Goodwin's recently published guide to biosimilar litigation.

5 Key Legal Developments for US Biosimilars in 2019

December 31st 2019

By Allison Inserro

Cases involving adalimumab featured in 2 of the 5 top legal stories in 2019 that dealt with various legal matters, including charges of patent thicketing.

Federal Circuit Affirms Amgen's Win Against Hospira in Epoetin Alfa Litigation

December 18th 2019

By The Center for Biosimilars Staff

This week, the US Court of Appeals for the Federal Circuit affirmed a district court decision against Pfizer subsidiary Hospira related to an epoetin alfa biosimilar.

Little Impact Post-Arthrex for Biologic Patents at the PTAB

December 3rd 2019

The Federal Circuit, in Arthrex, Inc v Smith & Nephew, Inc, ruled that the appointment of Administrative Patent Judges (APJs) at the Patent Trial and Appeal Board (PTAB) violated the Appointments Clause of the US Constitution, and held that APJs could be removed from office without cause. Absent a dramatic ideological shift in the PTAB, however, this decision likely will have little impact on how follow-on biologics developers use inter partes review (IPR).

Coherus, Amgen Settle Biosimilar Adalimumab Lawsuit

November 27th 2019

By The Center for Biosimilars Staff

Coherus BioSciences and Amgen have reportedly settled a patent lawsuit over biosimilar adalimumab.