Eye on Pharma: EC Approved Ustekinumab; Zymfentra Expansion; Biosimilar Policy Briefing

The European Commission (EC) approved Celltrion's ustekinumab biosimilar for chronic inflammatory diseases, Celltrion expanded access to Zymfentra (subcutaneous infliximab-dyyb) through partnerships with Cigna and Express Scripts, and the Association for Accessible Medicines held a policy briefing addressing barriers to biosimilar adoption.

EC Approves Ustekinumab Biosimilar

Celltrion announced that the EC has approved SteQeyma (CT-P43), an ustekinumab biosimilar referencing Stelara, for the treatment of various chronic inflammatory diseases.¹ SteQeyma is approved for use in gastroenterology, dermatology, and rheumatology, expanding treatment options for conditions such as Crohn disease. Stelara, the reference product, was the first biologic to target interleukin (IL)-12 and IL-23, cytokines essential to immune and inflammatory responses.

The decision was based on comprehensive clinical evidence, including a phase 3 study in patients with moderate to severe plaque psoriasis, which demonstrated that SteQeyma is highly similar to Stelara in terms of efficacy and safety, with no clinically meaningful differences.

Commenting on the approval, Taehun Ha, senior vice president and head of Europe division at Celltrion, said, “The EC approval of SteQeyma brings an important new therapeutic option to patients, and we’re excited to launch this innovative therapy, with a proven track record in Crohn’s and other immune diseases….This approval, alongside those of Remsima SC [Zymfentra in the US] and Yuflyma [adalimumab biosimilar], marks a key milestone in our strategy to strengthen Celltrion’s immunology offering, and with the recent approval of Omlyclo in May, we are looking forward to expanding our portfolio into the dermatology sector.”

SteQeyma is now Celltrion’s seventh biosimilar approved in the European Union, joining its portfolio that includes Remsima SC, Yuflyma, and other prominent biosimilars like Truxima (rituximab biosimilar) and Herzuma (trastuzumab biosimilar).

Zymfentra and Adalimumab Biosimilar Expansion

Celltrion USA announced an agreement with Cigna Healthcare and Express Scripts to expand patient access to Zymfentra (infliximab-dyyb), the only FDA-approved subcutaneous infliximab.² Effective August 1, 2024, Zymfentra will be listed as a preferred medication on Cigna’s medical formulary, covering 16.1 million insured lives.

Approved by the FDA in 2023, Zymfentra is used for maintenance therapy in adults with ulcerative colitis and Crohn’s disease after intravenous infliximab treatment. Although Zymfentra is deemed a biosimilar or a biobetter in international markets, it was approved as a novel agent in the US. The agreement aims to offer patients more flexibility and treatment options. This follows Express Scripts’ earlier move to list Zymfentra on its National Preferred Formulary.

Additionally, MedImpact Healthcare Systems, the largest independent provider of health solutions in the US, is expanding access to biosimilars referencing Humira (adalimumab), including the branded and unbranded versions of Simlandi (adalimumab-adaz), for patients with conditions like Crohn disease and rheumatoid arthritis.³ New patients can access these biosimilars through their pharmacy benefit, while those already taking Humira can continue doing so.

Patients switching from biosimilars can also return to Humira if needed. MedImpact said it prioritizes clinical interchangeability and affordability, offering biosimilars at the same cost as Humira, with flexibility in pharmacy options. This move aligns with MedImpact’s commitment to patient-centered, cost-effective care, ensuring supply chain stability and adding new biosimilars as they meet clinical and economic criteria.

Biosimilar Policy Briefing

The Association for Accessible Medicines (AAM) and its Biosimilars Council recently held a policy briefing for Congressional staff, addressing barriers preventing patient access to low-cost generic and biosimilar medicines, as reported by Drug Store News.⁴

The discussion focused on patent-related issues, such as patent thickets, settlements, and “skinny labeling,” and their impact on drug prices. David Gaugh, AAM’s interim president and CEO, emphasized that while generics and biosimilars significantly lower drug costs, patent thickets often hinder these savings.

The panel featured legal and industry experts, including representatives from AAM, Goodwin Procter, Sandoz, and Apotex. AAM, along with other organizations, also sent a letter to Congress advocating for legislation to stop patent thickets and reform pharmacy benefit manager practices that obstruct generic and biosimilar adoption.

Additionally, AAM released its 2024 U.S. Generic & Biosimilar Medicines Savings Report, showing that in 2023, the use of generics and biosimilars saved the US health care system $445 billion.

References

1. European Commission approves Celltrion’s SteQeyma^® (CT-P43), a biosimilar to Stelara^® (ustekinumab), for the treatment of multiple chronic inflammatory diseases. Celltrion. Press release; August 25, 2024. Accessed September 17, 2024. https://www.businesswire.com/news/molecularlab/20240819920486/en/European-Commission-approves-Celltrion%E2%80%99s-SteQeyma%C2%AE-CT-P43-a-biosimilar-to-Stelara%C2%AE-ustekinumab-for-the-treatment-of-multiple-chronic-inflammatory-diseases

2. Celltrion USA partners with Express Scripts and Cigna Healthcare to expand access to ZYMFENTRA™ (infliximab-dyyb), the first and only FDA-approved subcutaneous infliximab on their medical benefit formulary. Celltrion USA. Press release; August 28, 2024. Accessed September 17, 2024. https://www.celltrion.com/en-us/company/media-center/press-release/3212

3. MedImpact expands access to two Humira biosimilars for new patients. MedImpact Healthcare Systems. Press release; August 27, 2024. Accessed September 17, 2024. https://www.medimpact.com/clients/resources/press-releases/medimpact-expands-access-two-humira-biosimilars-new-patients

4. Levy S. AAM, Biosimilar Council host patent abuse Congressional briefing. Drug Store News. September 16, 2024. Accessed September 17, 2024. https://drugstorenews.com/aam-biosimilar-council-host-patent-abuse-congressional-briefing