News

Here are the top 5 biosimilar articles for the week of January 29, 2024.

In addition to the several reports that have come out quantifying how the gastroenterology biosimilar market is progressing, January marks the 1-year anniversary of adalimumab biosimilar competition in the US.

A study found SB15, an aflibercept biosimilar, is just as effective as its reference drug Eylea, the current standard treatment for neovascular age-related macular degeneration (nAMD), a condition that causes vision loss.

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.

Coherus Biosciences has sold its ranibizumab biosimilar (Cimerli) to Sandoz; Celltrion has completed its biologics license application filing for its tocilizumab biosimilar (CT-P47); Alvotech shares positive pharmacokinetic results for its denosumab biosimilar candidate.

Although manufacturing patents tend to be the most common type of patent referenced in litigation regarding biosimilar development, other patents actually have a greater impact on delays for biosimilar market launches.

During a 6-year follow-up period, a UK tertiary hospital observed greater biosimilar adoption than the English average after it implemented a new policy that prioritizes best-value biologics, including biosimilars, for new-start patients and those already treated with originators.

A 10-year analysis in Poland found that the introduction of biosimilar drugs significantly increased access to biologic therapies and Janus kinase (JAK) inhibitors for patients with rheumatic musculoskeletal diseases (RMDs), while also reducing treatment costs.

Here are the top 5 biosimilar articles for the week of January 22, 2024.

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.

A combined analysis of 3 studies found that the drug MB02 is comparable to reference bevacizumab (Avastin) in terms of its pharmacokinetics, safety, and immunogenicity.

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.

The FDA, Congress, biologic developers, and associations dedicated to evaluating the US biopharmaceutical space will need to work together to overcome challenges to biosimilar accessibility, says Sarfaraz K. Niazi, PhD, in his new column.

Biosimilar uptake was greater in Medicare Advantage plans when compared with traditional Medicare plans.

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.”

Here are the top 5 biosimilar articles for the week of January 15, 2024.

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.

As one study presented at the 2023 San Antonio Breast Cancer Symposium (SABCS) evaluated the use of circulating tumor DNA for response prediction after combination therapy with a trastuzumab biosimilar, another examined the efficacy of a pertuzumab biosimilar candidate.

A study examining biosimilar uptake patterns within different health insurance plans found that low-flexibility plans, such as health maintenance organizations and exclusive provider organizations, were more likely to initiate biosimilar therapies than more flexible plans.

A French study found that rituximab biosimilars, Rixathon and Truxima, were as effective and safe as the reference drug (Rituxan) in treating immune thrombocytopenia.

The FDA has approved Coherus Biosciences’ on-body injector version of Udenyca (pegfilgrastim-cbqv), making it the first biosimilar to reference Neulasta Onpro, the pegfilgrastim product that holds the majority of the pegfilgrastim market share.

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.

The proposed bevacizumab biosimilar BAT1706 (Bio-Thera Solutions) demonstrated equivalence to the reference product (Avastin) in a phase 3 comparative efficacy trial in patients with advanced nonsquamous non–small cell lung cancer (NSCLC).

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.

A recent study found that the COVID-19 pandemic had little impact on the knowledge and attitudes of German and Swiss pharmacists regarding biologics and biosimilars between 2020 and 2022.

Sarafraz K. Niazi, PhD, previews the new year and his hopes for the end of clinical efficacy testing for biosimilar approvals using examples from history of other scientific concepts that took time to gain traction.

Prerakkumar Parikh, PharmD, director of specialty clinical solutions at Magellan Rx Management, reacts to recent FDA approvals for the first natalizumab and tocilizumab biosimilars.

Starting April 1, 2024, Hyrimoz and an unbranded version of Humira manufactured by Sandoz will be covered across all CVS formularies.