Dermatology

Between new data coming out of conferences, new insights into adalimumab biosimilars, and a study evaluating the impact of biosimilars on patient out-of-pocket costs, the biosimilar space had a very eventful March.

A review article described the totality of evidence supporting the approval of the adalimumab biosimilar AVT02 (Simlandi; Alvotech) for all approved indications of the reference product, Humira.

Despite more biosimilars entering the market and generating significant savings for payers and health care systems, these savings are not resulting in lower out-of-pocket (OOP) costs for patients, according to a recent study.

Two posters presented at the American Academy of Dermatology (AAD) annual meeting examined the effects of switching from reference ustekinumab and adalimumab to biosimilar versions in patients with different types of psoriasis.

Government policies, including those related to prescribing incentives and interchangeability, need to be reworked to encourage biosimilar adoption and create meaningful savings for health systems, according to speakers at a recent webinar.

A recent study used difference-in-difference analysis to assess adalimumab sales volumes and expenditures in 6 countries with and 8 countries without available biosimilar adalimumab products.

Posters from Association of Cancer Care Centers 50th Annual Meeting and Cancer Center Business Summit (AMCCBS) and the American Academy of Dermatology (AAD) highlight the benefits of incorporating biosimilars into electronic medical records and the biggest barriers for home injection of biologics.

The adalimumab biosimilar SB5 was reported to be as safe and effective as the reference product in a review of randomized controlled trials and real-world studies on immune-mediated inflammatory diseases.

The FDA has approved Fresenius Kabi's tocilizumab biosimilar (Tyenne; tocilizumab-aazg), making it the second tocilizumab biosimilar overall and first tocilizumab biosimilar to be approved with both intravenous and subcutaneous administration options.

Biocon Biologics settled with the maker of Eylea (aflibercept), announcing a launch date for its biosimilar competitor in Canada; Sandoz has officially acquired Cimerli, a ranibizumab biosimilar; AARP Medicare Rx from United Healthcare has added Cyltezo (adalimumab-adbm) and removed the originator (Humira) from its formulary.

In its annual biosimilars report, Cardinal Health provided updates on how provider acceptance growth, evolving payer dynamics, and the growing pipeline for biosimilars will shape the biosimilar landscape over the next 5 years.

Samsung Bioepis provided multiple updates on its biosimilar projects, including a new partnership for its aflibercept biosimilar candidate as well as regulatory news in the European Union and Republic of Korea.

After receiving 3 complete response letters, Alvotech has officially received US approval for its adalimumab biosimilar (AVT02; Simlandi), making it the first approval for the company, the 10th biosimilar to reference Humira, and the third interchangeable adalimumab biosimilar.

A study investigating SARS-CoV-2 antibody levels after treatment with reference or biosimilar adalimumab found significant decreases in antibody levels in those receiving biologic therapy compared with those who did not.

The US Department of Veterans Affairs (VA) has chosen to replace Humira (adalimumab) with Organon’s biosimilar version on its national formulary; Biocon Biologics and Sandoz announce a new partnership in Australia for 2 biosimilars; Alvotech settles with Johnson & Johnson over its biosimilar to Stelara (ustekinumab) for the European and Canadian markets.

Cyltezo (adalimumab-adbm) was the first adalimumab biosimilar—and second biosimilar overall—to receive an interchangeability designation from the FDA.

Similar efficacy, safety, pharmacokinetics, and immunogenicity were found when comparing Stelara, originator ustekinumab, and CT-P43, an ustekinumab biosimilar candidate, in patients with moderate to severe plaque psoriasis.

The authors of a meta-analysis assessing several disease states found no significant differences in serious adverse events, deaths, or treatment discontinuations between patients who switched from reference products to biosimilars and those who did not.

Vizient’s most recent Pharmacy Market Outlook report showcased the success of biosimilars while also emphasizing the impact of inflation on different drug classes, particularly in oncology and immunology.

The Center for Biosimilars® looks back at the first year of adalimumab biosimilars on the US market, including every product launch and approval as well as market trends and pricing strategies.

A Korean health agency issued Samsung Bioepis an administrative penalty related to its biosimilar referencing Eylea (aflibercept); the FDA updates its labeling recommendations for interchangeable biosimilars; Alvotech receives another Form 483 after the FDA reinspected its Iceland-based manufacturing facility.

Samsung Bioepis’ Biosimilar Market Report for the first quarter of 2024 chronicles some major market trends, including which treatment spaces have quicker uptake than others, highlighting missed opportunities for savings as well as the 1-year experience of adalimumab biosimilar competition in the US.

Authors of a review of available postapproval pharmacovigilance data assessing 8 Sandoz biosimilars concluded that these biosimilars “can be used as safely as their respective reference biologics.”

The IQVIA Institute for Human Data Science’s most recent Global Use of Medicines report projected that market introductions of new biosimilar and generic drugs will increase projected losses for originator products from $111 billion to $192 billion over the next 5 years.

Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, reacts to the biggest FDA approvals of 2023 and how she sees the adalimumab, natalizumab, and tocilizumab spaces playing out.

As Regeneron gears up for a legal battle with biosimilar competitors for its reference aflibercept, CareFirst files a lawsuit against Johnson & Johnson for restricting biosimilar ustekinumab competition; Celltrion and Accord BioPharma file with the FDA to approve their respective biosimilar candidates.

The European Medicines Agency (EMA) has granted marketing authorization to the first ustekinumab biosimilar, STADA Arzneimittel and Alvotech’s Uzpruvo.

IQVIA’s report on the impact biosimilar competition has had on Europe’s health care space identified ongoing challenges with biosimilar access and generating savings, calling for more policies focusing on fostering a sustainable market for years to come.

Adults with inflammatory diseases maintained disease control when transitioning from originator adalimumab (Humira) to biosimilar SB5 in a pan-European study.

The FDA agreed to review an application for Hadlima (adalimumab biosimilar) to be granted interchangeability; The European Union’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for an ustekinumab biosimilar; the Biosimilars Forum expressed support for a Senate Finance Committee’s draft legislation promoting biosimilars.