Rheumatology

Sandoz’ applications for its Tysabri biosimilar (natalizumab) and its high-concentration version of its Humira biosimilar (adalimumab) were accepted for review by the FDA and the European Medicines Agency.

On this podcast episode, The Center for Biosimilars spoke with Chronis Manolis from UPMC Health Plan to discuss how health care policies may shift as adalimumab biosimilars referencing Humira come to market in 2023, including how providers and payers can ensure equitable access.

In recent weeks, Celltrion Healthcare furthered its adalimumab biosimilar (Yuflyma) by launching the drug in Spain and Portugal and starting a clinical trial in France while Xbrane Biopharma provided an update on the FDA filing of its ranibizumab biosimilar.

A real-world study on Pfizer and Celltrion Healthcare’s infliximab biosimilar (infliximab-dyyb, Inflectra; CT-P13) demonstrated positive clinical and patient-reported outcomes in patients with inflammatory bowel disease (IBD) in the United States and Canada.

Amgen's early view said health care savings from the use of these biologic therapies climbed to $3 billion in the second quarter of 2022, for total of $18 billion over the past 6 years.

Having patients meet with a clinical pharmacist before a rheumatologist could help improve biosimilar adoption rates and mitigate the nocebo effect in patients with chronic diseases, according to a recent study.

Not long after the company announced its new global initiative to promote access and increase adoption of biosimilars, Sandoz’ biologics license application for its high-concentration adalimumab biosimilar was accepted by the European Union’s regulatory agency for review.

Data showing the clinical outcomes of Samsung Bioepis’ biosimilar referencing Humira (adalimumab) were shared at the European Congress of Rheumatology’s annual meeting, EULAR 2022.

Results from the European Congress of Rheumatology’s annual meeting revealed that Celltrion’s Remsima SC, a subcutaneous biobetter infliximab product, produced better clinical outcomes compared with the original Remsima, an infliximab biosimilar delivered intravenously.

A study assessing the impact of mandatory switching policies in British Columbia on patients with rheumatic conditions receiving infliximab therapy found that switching to a biosimilar did not result in increased health service use.

Alvotech released new data demonstrating the equivalence of its ustekinumab biosimilar (AVT04) to the reference product (Stelara) in patients with plaque psoriasis.

Authors of a new study demonstrated that multiple switches between infliximab biosimilars CT-P13 and SB2 and the reference product (Remicade) were safe and effective in patients with inflammatory bowel disease (IBD).

In a pharmacokinetic study, Alvotech’s ustekinumab biosimilar referencing Stelara was shown to have comparable safety and efficacy to the reference product, according to the company’s preliminary results.

Jeffrey Casberg, vice president of pharmacy at IPD Analytics, discusses the Alvotech/AbbVie settlement for an adalimumab biosimilar and whether it will impact future patent lawsuits.

Biosimilars provide significant savings and encourages competition in the biopharmaceutical marketplace but the United States needs to do more to empower uptake and address adoption barriers, according to Robert Popovian PharmD, MS.

Posters from the Academy of Managed Care Pharmacy (AMCP)’s annual meeting highlighted the clinical similarity of a trastuzumab biosimilar compared with its reference product and real-world longitudinal application of infliximab biosimilars.

Medicare Part D plans missed out on between $84 million and $143 million in savings by not prioritizing the use of biosimilars over reference products, according to a report from the HHS Office of Inspector General.

A phase 3 study conducted by Amgen found that the company’s ustekinumab biosimilar was as safe and efficacious as the reference product (Stelara) in patients with moderate to severe plaque psoriasis.

A sub-study assessing the affects of using a prefilled pen vs a prefilled syringe found that the pen was easy for patients to use and was favored by over 90% of patients.

Jeffrey Casberg, vice president of pharmacy at IPD Analytics, weighs in on the factors he thinks will most affect market share among adalimumab biosimilars when they enter the US market in 2023.

Republic of Korea-based Celltrion Healthcare launched its high-concentration adalimumab biosimilar in Canada and won several Brazilian tenders to supply its infliximab biosimilar.

During the month of March, rheumatology biosimilars have received a lot of praise in a regulatory, business, and legal sense, especially regarding the landmark settlement between Alvotech and AbbVie over an adalimumab biosimilar.

An article reviewed the totality of evidence leading to the approval of Amgen’s infliximab biosimilar ABP 710 (Avsola), which is currently approved in the US and Canada for all the indications of the originator (Remicade).

A patient with ankylosing spondylitis (AS) and ulcerative colitis (UC) was diagnosed with polychondritis after taking an infliximab biosimilar, suggesting that patients with similar circumstances should be carefully monitored.

Since the start of 2022, China’s National Medicinal Products Administration (NMPA) has made strides to increase access to biosimilar products for various rheumatic conditions, including 3 biosimilar approvals and 1 biosimilar receiving an expanded indication.

Julie M. Reed, the new executive director of the Biosimilars Forum, shares how the Forum is preparing for the US market introduction of the first FDA-approved adalimumab biosimilars.

AbbVie settles outstanding lawsuits, including its case related to the International Trade Commission (ITC), with Alvotech, giving Alvotech the green light to launch its high-concentration, citrate-free adalimumab biosimilar referencing Humira in July 2023, pending FDA approval.

Shanghai Henlius Biotech announced a commercialization agreement with Getz Pharma Limited for an adalimumab biosimilar for various African and Asian countries.

The FDA has accepted biologics license applications (BLAs) for interchangeability status from Alvotech and Pfizer regarding their respective adalimumab biosimilars referencing Humira.

Switching patients with Crohn disease from reference adalimumab to SB5, a Samsung Bioepis biosimilar, did not lead to major changes in disease activity in a real-world analysis.