Legal

FDA Grants Interchangeable Status for Boehringer Ingelheim's Adalimumab Biosimilar (Cyltezo)

October 15th 2021

By Tony Hagen

The interchangeable designation allows pharmacists more flexibility to dispense this potentially money-saving product and gives Boehringer Ingelheim a marketing edge.

Court Dismisses AbbVie's Trade Secret Piracy Case Against Alvotech

October 7th 2021

By Tony Hagen

A US District Court in Illinois has ruled that although trade secret theft may have occurred over an adalimumab biosimilar candidate, it happened far from the state. With only a very "attenuated" connection, there are no grounds to bring action against Alvotech in the case of purloined manufacturing data, the judge stated.

Twelve-Month Court Battle Will Delay Adalimumab Biosimilar Launch for Alvotech

October 6th 2021

By Tony Hagen

The court battle between AbbVie and Alvotech could be a defining victory in the struggle to bring biosimilar versions of adalimumab to market, but a yearlong court process must play out first.

Opinion: The “Forgotten Molecules” May Reward Biosimilar Developers

October 2nd 2021

By Sarfaraz K. Niazi, PhD

The Center for Biosimilars® Advisory Board member Sarfaraz K. Niazi, PhD, explains an “against the grain” approach to tapping unmet need and revenue potential in biosimilars.

Medicines for Europe Experts Discuss EU Market for Biosimilars, Part I

September 28th 2021

Adrian van den Hoven, director general for Medicines for Europe, and Diogo Piedade, market access manager for Medicines for Europe, discuss the group’s recent EU report: Market Review—Biosimilar Medicine Markets.

Amgen Estimates $9.8 Billion in Cumulative US Biosimilar Savings

September 22nd 2021

By Tony Hagen

In a biosimilar trend report, Amgen discusses marketing achievements, US biosimilar policy, payer and provider acceptance of these agents, and the outlook for further growth.

Axinn’s Landmon Provides an Expert Legal Opinion on HHS’ Drug Price Strategy

September 22nd 2021

The HHS plan ordered up by President Biden for combatting high drug prices is a hodgepodge of ideas that have long circulated in Washington, DC, but can any of them be made to stick? An intellectual property and FDA policy expert, Chad Landmon, JD, shares his perspective.

BIO Attorneys Discuss the BPCIA Patent Dance

September 15th 2021

By Tony Hagen

The “patent dance” under the Biologics Price Competition and Innovation Act (BPCIA) is meant to resolve litigation efficiently, and it does, although in practice biosimilar developers and originator companies may not completely adhere to the prescribed steps, according to Biotechnology Innovation Organization (BIO) experts.

Alvotech Reports Positive Switching Results for AVT02 Adalimumab Candidate

September 9th 2021

By Tony Hagen

The findings support Alvotech's bid for interchangeable status for the high-concentration, citrate-free adalimumab biosimilar candidate.

Strength of Patent Protection Varies by Patent Type

September 9th 2021

By Tony Hagen

The strength of a patent wall built up around an originator biologic depends on the quality of patents that make it up and the originator company's willingness to engage in costly litigation. Part 2 of a series.