Tony Hagen

Sean McGowan, senior director of Biosimilars for AmerisourceBergen, forecasts potential biosimilar approvals and launches in 2022 as well as offers insights into how emerging biosimilars will impact the market and pricing in the coming years during an interview.

Bret Jackson, president of the Economic Alliance for Michigan, notes that Ford Motor is a biosimilar success story, having saved a significant amount of money on just a handful of drugs.

The International Generic and Biosimilar Medicines Association has appointed a veteran member, Vivian Frittelli, MBA, ACIS, to take over as chair.

Ford Motor saved $5 million by switching patients to 5 biosimilars, and other manufacturers and employers in Michigan have achieved good results with switching programs, the Economic Alliance of Michigan reports.

As chief science policy officer for Global Healthy Living Foundation, Robert Popovian, PharmD, MS, has a bird’s-eye view of some of the central issues of biosimilar access in the United States.

Amgen Chairman and CEO Robert Bradway touted the potential of 11 biosimilars anticipated to be driving revenues for the company by 2030.

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

In India, an emphasis on outdated biosimilar testing has restricted market entry of these products and discouraged manufacturers, patient advocates contend.

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.

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

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.

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.

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.

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.

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

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.

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).

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