The AJMC® Biosimilars compendium is a comprehensive resource for news and expert insights into these biological products, including clinical research, patent and legal news, and regulatory updates.

Patents Filed a Decade Post Originator Approval Account for Most Biosimilar Patent Lawsuits

January 21st 2022, 9:45pm


Researchers have found that most US patent infringement cases against biosimilar manufacturers cover patents filed over a decade after the originator product's FDA approval, leading to limits on competition among biologic drugs.

Trastuzumab Biosimilar Has Similar Efficacy, Safety to Reference Product in Advanced Gastric Cancer

January 19th 2022, 10:10pm


The trastuzumab biosimilar Herzuma was shown to have similar clinical efficacy and safety to the reference product in patients with HER2-positive advanced gastric cancer.

US Uptake of Biosimilars Remains Suboptimal and Requires Intervention

January 15th 2022, 7:00pm


Compared with the European Union, biosimilar use in the United States lags, and the US government, health systems, and medical associations all have a role to play.

Ophthalmology Biobetters and Biosimilars May Be Just Around the Corner

January 12th 2022, 8:45pm


More biobetter drugs may be on the horizon, with an opportunity to snatch market share from reference products, and several biosimilars are under development for ophthalmic conditions, authors of a review concluded.

Approvals, Policy Changes Raise Profile of Biosimilars in Canada

January 4th 2022, 5:25pm


At least 8 biosimilars were approved in Canada over the past 12 months, as policy makers made a strong push for biosimilar acceptance, which led to a change in prescribing patterns.

Projected US Savings From Biosimilars, 2021-2025

January 3rd 2022, 5:00pm


Projected savings from biosimilars from 2021 to 2025 were $38.4 billion vs conditions as of quarter 4 of 2020 and were driven by new biosimilar entry. Savings were $124.5 billion under an upper-bound scenario.

Yusimry, the Seventh Adalimumab Biosimilar, Gains FDA Approval

December 26th 2021, 2:00pm


Despite being the seventh adalimumab biosimilar approved in the United States, there are none on the market yet.

Top 5 Most-Read Biosimilars News of 2021

December 22nd 2021, 3:15pm


This year the United States only approved 2 biosimilars, but the FDA did grant interchangeable status to the first biosimilar.

No Easy Path to Market for Alvotech's Adalimumab Biosimilar

December 20th 2021, 8:07pm


In hopes of protecting its lucrative adalimumab (Humira) franchise, AbbVie is mounting a hefty legal defense against Alvotech's adalimumab biosimilar candidate.

Findings Are Reported From De-escalation Therapy in Early Breast Cancer

December 15th 2021, 8:35pm


Investigators said pathologic complete response was higher with a molecularly selected subgroup of patients with early-stage breast cancer treated with a nonchemotherapy combination that included a trastuzumab biosimilar.