Rheumatology

FDA Delays Review of Alvotech's AVT02 Adalimumab Biosimilar Candidate

September 21st 2021

By Tony Hagen

Reykjavik, Iceland company Alvotech said the FDA review of its adalimumab candidate is held up by pandemic-related curbs on overseas inspections.

Not So Different: How Biosimilar Companies Are Stepping Up Their Game to Compete Against Originators

September 19th 2021

Kirollos Hanna, PharmD, from the University of Minnesota Medical Center, discusses some of the tactics that biosimilar companies are employing in order to level the playing field and better compete against originator companies.

Roundup: Adalimumab Biosimilar Advancements and a Biosimilar Pill

September 17th 2021

By Tony Hagen

Alvotech gains an EU marketing recommendation for AVT02, a proposed adalimumab biosimilar; New Zealand may give preferential status to Amgen's adalimumab biosimilar; BioFactura looks to deliver ustekinumab via a robotic pill.

ASBM Appoints New Chair in Battle Against Nonmedical Switching

September 14th 2021

By Tony Hagen

The Alliance for Safe Biologic Medicines (ASBM) has fought since 2010 in opposition of payer policies that promote automatic switching to cheaper biologics including biosimilars. The group's new chair is no newcomer to this battle.

Enzene and Hetero Gain DCGI Approvals for Denosumab, Tocilizumab Products

September 13th 2021

By Tony Hagen

Companies that gain Drug Controller General of India (DCGI) marketing authorization are likely in for much more extensive trials if they hope to commercialize their biosimilars on the global platform.

Opinion: FDA Changes to Biosimilar Development Guideline Save Money and Time

September 11th 2021

By Sarfaraz K. Niazi, PhD

Refinements to the analytical testing of biosimilar candidates to verify similarity were worked into 2019 guidance from the FDA. These changes offer what the author considers a more "rational approach."

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.

Analyst: China Leads APAC Region for Biosimilar Development, Marketing

September 7th 2021

By Tony Hagen

Shanghai Henlius Biotech, Innovent Biologics, and other Chinese biopharmaceutical makers are leading the wave of Asia-Pacific (APAC) biosimilar development, according to a GlobalData analyst.