Eye on Pharma: Interchangeability Study Results; Express Scripts to Cover Cyltezo; TDM for Idacio

Samsung Bioepis and Organon released results from an interchangeability study of its adalimumab biosimilar; Express Scripts announced that it will add Cyltezo as well as 2 other adalimumab biosimilars to its formulary list; Anser Therapeutics will offer therapeutic drug monitoring (TDM) for Idacio.

Phase 4 Interchangeability Study

Samsung Bioepis and partner Organon released results from a phase 4, randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter clinical study evaluating the interchangeability of SB5 (Hadlima), an adalimumab biosimilar, and Humira (reference adalimumab).

The study, conducted from August 2022 to May 2023, included 371 adalimumab-naïve patients with moderate to severe plaque psoriasis recruited from 33 sites in 4 countries (Bulgaria, Czechia, Lithuania, Poland). Patients were treated with the reference product for the first 13 weeks of the study. At week 13, patients who achieved at least a 50% reduction in Psoriasis Area and Severity Index were randomized 1:1 to continue with Humira or switch to SB5.

The study achieved all primary end points (pharmacokinetic end points of area under the plasma concentration-time curve for a dosing interval and peak concentration at week 23-25). Safety, efficacy, and immunogenicity profiles were also similar between treatment arms.

Express Scripts to Cover Cyltezo

After announcing that it would add multiple adalimumab biosimilars to its formulary list, Express Scripts confirmed that one of the products would be Boehringer Ingelheim’s Cyltezo, the only interchangeable adalimumab biosimilar in the United States.

The pharmacy benefit manager shared that Sandoz’ branded and unbranded adalimumab biosimilars (Hyrimoz, adalimumab-adaz) would also be added to the list. Cyltezo is a low-concentration adalimumab biosimilar and only the high-concentration versions of Hyrimoz and unbranded adalimumab-adaz were listed. All 3 biosimilar products will be covered at parity with Humira, and join Amgevita (low-concentration), the first adalimumab biosimilar to launch in the United States, on the list.

“In any industry, competition often leads to lower prices, and until recently, Humira had little competition…. Embracing biosimilars as they come to market builds on our efforts over the past decade to support greater adoption.… We believe that, like generic medications, biosimilars can drive greater affordability for individuals with chronic and complex conditions who need it most," said Adam Kautzner, PharmD, president of Express Scripts.

Evernorth, the parent company of Express Scripts, estimated that biosimilars could save the United States between $225 billion and $375 billion in total pharmacy spend over the next 10 years.

TDM Services for Idacio

Prometheus Laboratories announced that it was collaborating with Fresenius Kabi to support the validation of and access to Anser Therapeutics TDM services for patients receiving Idacio, Fresenius Kabi’s adalimumab biosimilar.

“For many health care professionals, therapeutic drug monitoring has become standard of care when treating inflammatory bowel disease patients with biologics and biosimilars. The availability of Anser testing for new agents, like these biosimilars, supports our mission as clinicians to get our patients expediently and cost-effectively into lasting remission,” said Adam Cheifetz, MD, director, Center for Inflammatory Bowel Diseases at Beth Israel Deaconess Medical Center and professor of medicine at Harvard Medical Center.

Anser testing is used by rheumatologists and gastroenterologists to gain objective information that will help inform therapeutic decisions. The collaboration will also be used for patients receiving Fresenius Kabi’s tocilizumab and ustekinumab biosimilars upon market availability.

TDM is testing that measures the amount a certain medication in the blood to make sure the amount of medicine is safe and effective. TDM can help providers determine the best dosages for people taking hard-to-dose medicines, such as biologics for autoimmune diseases, heart drugs, and antibiotics.

“There is evidence on the clinical and health economic value of therapeutic drug monitoring for biologics and biosimilars in autoimmune diseases. The availability of Anser testing for an adalimumab biosimilar like Idacio will be a welcome addition to the care protocol of our Rheumatoid Arthritis patients,” commented Alan J. Kivitz, MD, certified physician investigator, founder, and medical director of the Altoona Center for Clinical Research and Altoona Arthritis and Osteoporosis Center.