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In a recent paper, Sarfaraz K. Niazi, PhD summarizes some of his central ideas on the relevance of FDA biosimilar testing standards.

Simlandi (AVT02) is the second high-concentration, citrate-free adalimumab (Humira) biosimilar to be approved in the Canada market.

Wayne Winegarden, PhD, a senior fellow in business and economics at Pacific Research Institute, discusses his predictions for etanercept and adalimumab biosimilar pricing and why he hopes manufacturers will offer them at large discounts to reference biologics.

In India, an emphasis on outdated biosimilar testing has restricted market entry of these products and discouraged manufacturers, patient advocates contend.

Here are the top 5 biosimilar articles for the week of January 3, 2022.

Biobetters may gain an edge on reference products, and multiple biosimilars are under development for ophthalmic disorders, the authors write.

The companies hope to gain FDA approval for a high-concentration, citrate-free version of Hadlima, an adalimumab biosimilar that was approved in a lower concentration in July 2019.

A comparative study of PanGen Biotech’s epoetin alfa biosimilar candidate PDA10 and the reference product, Retacrit, demonstrated comparable efficacy and safety.

Savings from adalimumab biosimilars, which won't enter the US market until 2023, account for a significant share of the total, investigators said.

Patients with stage IV nonsquamous non–small cell lung cancer (NSCLC) demonstrated equivalent outcomes when treated with MYL-1402O or Avastin.

Wayne Winegarden, PhD, a senior fellow in business and economics at Pacific Research Institute, explains pricing issues for reference drugs and biosimilars.

Biosimilars have produced more than $20 billion of savings in Europe, but more use of these agents is needed.

The top legal stories in biosimilars over the past year concerned etanercept and adalimumab biosimilars and access to insulin.

With an FDA approval for a second insulin glargine biosimilar, the stage is set for stronger competition in 2022 with potential improved access and savings for patients.

The Center for Biosimilars® spoke recently with Chad Landmon, chair of the Intellectual Property and Food and Drug Administration Practice Groups at Axinn, a New York–based antitrust, intellectual property, and litigation law firm.

Wayne Winegarden, PhD, discusses his savings analysis for adalimumab and etanercept biosimilars and their potential market share.

With fewer of the risks associated with novel drug development, biosimilar candidates allow manufacturers to plan far into the future for marketing needs.

In Canada, a new jurisdiction inaugurates mandatory switching to biosimilars.

Business stories about Celltrion, the potential for mRNA biosimilar vaccines, and Amgen's biosimilars overview topped the rankings for reader popularity in 2021.

From the approval of the first insulin glargine biosimilar (Semglee) to the potential for extreme biosimilar competition in the adalimumab market, 2021's regulatory stories were popular with readers.

The year 2021 brought several firsts in biosimilars and set the stage for expansion across therapeutic areas including diabetes and ophthalmology.

Coherus BioSciences said the 40 mg subcutaneous formulation of adalimumab would be launched on or after July 1, 2023, in agreement with AbbVie, maker of Humira, the reference product.

After an unsuccessful attempt to get an Illinois court to block the distribution of Alvotech's adalimumab candidate, AbbVie has tried again in a new forum.

A trio of regulatory experts discuss the current standing of biosimilar policy in the United States and expectations going forward.

Investigators said pathologic complete response (pCR) improved in a trastuzumab biosimilar/pertuzumab trial when patients were preselected for a subtype of breast cancer.

An economist weighs in on whether interchangeable status will help adalimumab biosimilars succeed.

In a pharmacokinetic (PK) and pharmacodynamic (PD) trial in healthy participants, Samsung Bioepis' SB12 eculizumab biosimilar candidate demonstrated equivalence to Soliris, the reference product.

Here are the top 5 biosimilar articles for the week of December 13, 2021.

Alvotech has received European Commission (EC) approval to begin marketing its adalimumab biosimliar AVT02, the company announced this week.

Investigators said more evidence would help to convince clinicians of the safety of switching between biosimilar products.