Legal

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.

BIO Attorneys Address Patent Thicket Misconceptions

September 8th 2021

By Tony Hagen

In this first part of a series, intellectual property attorneys from the Biotechnology Innovation Organization (BIO) contend that originator patents are not the formidable obstacles to biosimilars they are made out to be.

The Inner Workings of the BPCIA Patent Dance

July 24th 2021

By Alejandro Menchaca, JD

The Biologics Price Competition and Innovation Act (BPCIA) provides a stepwise approach for fact-finding prior to patent litigation, but companies may choose their own path, case examples show.

Pfizer Resolves Antitrust Lawsuit With J&J Over Remicade

July 22nd 2021

By Tony Hagen

Without disclosing terms, Pfizer said it has settled with Johnson & Johnson (J&J) over a long-running dispute in which J&J was alleged to have blocked payers from covering Inflectra.

How Risky Was Amgen's Onpro Advertising?

July 19th 2021

By Tony Hagen

Amgen's advertising appeared to push doctors and patients away from the prefilled syringe version of its pegfilgrastim (Neulasta) product, which may have a better sales future than the Onpro.

ACI Panelists Discuss Misaligned Incentives in the Biosimilars Market

July 15th 2021

By Tony Hagen

Panelists at the American Conference Institute's 2021 meeting took on the complexities of biosimilar adoption in a wide-ranging discussion.