FDA Tweaks Biosimilar Application Review Program

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.

Samsung Bioepis Reports Long-term Ontruzant Findings for HER2-Positive Breast Cancer

September 14th 2021

By Tony Hagen

The positive findings for the trastuzumab biosimilar Ontruzant in patients with human epidermal growth factor receptor 2 (HER2)–positive early or locally advanced breast cancer were presented at the European Society for Medical Oncology (ESMO) Congress 2021.

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."

The Top 5 Biosimilar Articles for the Week of September 6

September 10th 2021

Here are the top 5 biosimilar articles for the week of September 6, 2021.

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.