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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.

Xbrane Biopharma of Stockholm, Sweden, said its next biosimilar candidates will target the demand for oncology and hematology therapeutics.

In metastatic breast cancer (mBC) resistant to multiple lines, Herzuma (a trastuzumab biosimilar) plus gedatolisib, an mTOR/PI3K signaling pathway inhibitor, demonstrated value.

After a switch to a biosimilar, patients and their oncologists may not always agree on how well the switch was described or whether the patient felt involved.

Etanercept and adalimumab biosimilar competition is not only necessary to drive down prices, it’s long overdue, according to Wayne Winegarden, PhD, a senior fellow in business and economics at Pacific Research Institute.

Tot Biopharm receives China regulatory approval for a bevacizumab biosimilar and Fujifilm moves forward with plans for a Suzhou Innovation and Collaboration Center.

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

The trial included "drifted" (nonstandard) reference product, forcing a stratified analysis to yield relevant data.

Ahead of sales and revenues, Icelandic company Alvotech lines up a massive capital investment and an initial public offering (IPO).

The arrival of biosimilars for filgrastim and pegfiltrastim coincided with higher use of granulocyte colony-stimulating factor (G-CSF) for prophylaxis against febrile neutropenia, but many high-risk patients still do not receive the treatment.

A trastuzumab biosimilar candidate demonstrated equivalence to Herceptin in patients with early-stage human epidermal growth factor receptor 2 (HER2)–breast cancer.

In a review, Sandoz researchers discuss lingering barriers that prevent insulin prices from falling to more affordable levels.

Henlius gains approval in China for Hanbeitai and officials discuss combination therapy options with experimental therapy serplulimab and ophthalmology treatment.

Steven Yates, MD, an oncologist and medical director at Intermountain Healthcare, discusses problems underlying the 340B Drug Pricing Program.

Here are the top 5 biosimilar articles for the week of November 29, 2021.

Researchers report findings that suggest a different reimbursement system for Medicare Part B biologics could lead to significantly more robust savings.

In the second setback this year for etanercept biosimilars, the US District Court for the District of New Jersey has ordered Samsung Bioepis to delay marketing Eticovo until 2029.

Regulators are at work clarifying biosimilar guidance and on Capitol Hill, a battle is raging over reforms that could help or hurt biosimilar advancement.

Specialty tiers for biosimilars and reforms that address the proliferation of poor-quality patents would help lower costs and improve access, biosimilar industry veterans said.

Karen van Caulil, PhD, president and CEO at Florida Alliance for Healthcare Value, discusses the difficulty her institution has had in getting providers and employers to switch to biosimilars.