Gastroenterology

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In India, an emphasis on outdated biosimilar testing has restricted market entry of these products and discouraged manufacturers, patient advocates contend.

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

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.

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

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.

Authors of a new study estimated significant savings from biosimilars in Ontario based on deep price discounts and mandatory switching programs.

Stakeholder education programs and robust data on clinical studies are key to building patient and provider support for biosimilars, according to a new whitepaper.

The conservative think tank Pacific Research Institute (PRI) calculated potential biosimilar savings across multiple market share scenarios.

Kathy Oubre, MS, a cochair of the biosimilars committee of the Community Oncology Alliance (COA), explains findings from a broad study of biosimilar use in oncology practices.

In its first quarter of independence from Pfizer, Organon saw growth in biosimilars revenue; Sandoz' biosimilar portfolio has been touted as a growth driver amid talk of a spinoff from Novartis.

Payers have moved from toe-in-the-water biosimilar policies to aggressive management, contributing to much more robust savings in recent years, according to Leslie Fish, RPh, PharmD, vice president of pharmacy at IPD Analytics.

Patients with and without experience with tumor necrosis factor (TNF)–blocker biologics have incomplete knowledge of biosimilars for these agents, according to findings presented at the Academy of Managed Care Pharmacy 2021 Nexus meeting.

Investigators in Spain said they found no significant differences in outcomes for patients who switched from adalimumab originator to 1 of multiple adalimumab biosimilars.

The interchangeable designation allows pharmacists more flexibility to dispense this potentially money-saving product and gives Boehringer Ingelheim a marketing edge.

The court battle between AbbVie and Alvotech could be a defining victory in the struggle to bring biosimilar versions of adalimumab to market, but a yearlong court process must play out first.

Preventing the nocebo effect requires a demonstration of confidence in biosimilars from all health care practitioners, including pharmacists, experts said in a newly published rheumatology treatment guidance document.

Studies of the infliximab biosimilar Remsima in patients with inflammatory bowel disease were presented at United European Gastroenterology Week 2021.

The month of September 2021 was chock-full of biosimilar news. From regulatory actions to policy initiatives to clinical news, no dust was gathering on the road toward wider biosimilar adoption.

In a biosimilar trend report, Amgen discusses marketing achievements, US biosimilar policy, payer and provider acceptance of these agents, and the outlook for further growth.

Reykjavik, Iceland company Alvotech said the FDA review of its adalimumab candidate is held up by pandemic-related curbs on overseas inspections.

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 findings support Alvotech's bid for interchangeable status for the high-concentration, citrate-free adalimumab biosimilar candidate.