Eye on Pharma: Ustekinumab Updates; Ranibizumab Trial; Julie Reed PBM Piece

Several companies receive good news regarding their ustekinumab biosimilars; Lupin Limited completes a phase 3 trial for a ranibizumab candidate; Julie Reed, MS, executive director of the Biosimilars Forum weighs in on pharmacy benefit managers (PBMs) and biosimilar access.

Ustekinumab Updates

Celltrion Healthcare Canada has announced that Health Canada has approved Steqeyma (ustekinumab injection) and Steqeyma I.V. (ustekinumab for intravenous infusion) for treating moderately to severely active Crohn disease, moderate to severe plaque psoriasis, and active psoriatic arthritis in adults.¹ The approval, based on phase 3 trial results showing comparable efficacy and safety to the reference product Stelara, marks a significant addition to Celltrion's immunology pipeline.

“Plaque psoriasis and psoriatic arthritis are debilitating, inflammatory diseases that impact patients’ quality of life in various ways,” said Kim Alexander Papp, MD, PhD, a dermatologist with Probity Medical Research, Waterloo and University of Toronto. “Approximately 1 million Canadians are affected with psoriasis. The introduction of this new therapeutic option offers renewed hope for individuals managing psoriasis and related chronic inflammatory conditions.”

Additionally, Formycon and its commercialization partner Fresenius Kabi have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for FYB202, a biosimilar to Stelara (ustekinumab).² The recommendation is a crucial step towards obtaining European Commission approval, anticipated by early fourth quarter 2024.

FYB202, which targets cytokines IL-12 and IL-23 to treat serious inflammatory diseases, showed comparable efficacy and safety to Stelara in clinical trials. The approval could enhance patient access to affordable treatments and significantly boost Formycon’s revenues and profitability.

Completion of a Ranibizumab Trial

Lupin Limited said it has successfully completed a global phase 3 clinical study for LUBT010, a biosimilar candidate to Lucentis (ustekinumab), achieving the primary endpoint of therapeutic equivalence in improving visual acuity for patients with wet age-related macular degeneration.³ The study demonstrated comparable safety and immunogenicity between LUBT010 and Lucentis. Lupin plans to file for marketing approvals with the FDA and EMA and has been marketing a similar biosimilar, RaniEyes, in India since 2022.

“We are very pleased with the positive outcome of the global Phase 3 study, which marks yet another significant developmental milestone for our Lucentis® Biosimilar. It is a reaffirmation of our focus on developing high-quality biosimilars, to cater to patient needs,” said Cyrus Karkaria, PhD, president of Lupin Biotech. “We will be filing marketing applications for LUBT010 in all major global markets this year.”

Julie Reed Weighs in on PBM Tactics

Julie Reed, the executive director of the Biosimilars Forum, wrote an opinion piece in STAT News that criticized PBMs for prioritizing high-cost, high-rebate drugs over affordable biosimilars, despite the potential for significant cost savings.⁴ It called for urgent reform to address the monopolistic practices of PBMs and improve patient access to affordable medications.

The piece follows the Federal Trade Commission's interim report on PBMs, which emphasized how these powerful intermediaries push patients toward high-cost, high-rebate drugs, inflating overall drug costs and restricting access to lower-cost options, including biosimilars. The report follows congressional scrutiny that revealed PBMs' role in directing patients away from affordable treatments, like the newly available biosimilars for Humira, which could significantly reduce healthcare costs.

Despite the potential savings of up to $133 billion by 2025 from increased biosimilar use, PBMs have prioritized their profits over patient access, limiting the availability of cost-effective medications. This situation underscores the need for immediate reform to address the monopolistic practices of PBMs and ensure fair competition in the pharmaceutical market.

References

1. Health Canada approves Celltrion’s Steqeyma®, a biosimilar to Stelara® (ustekinumab) for the treatment of multiple chronic inflammatory conditions. Celltrion Healthcare Canada Limited. News release. August 1, 2024. Accessed August 5, 2024. https://www.businesswire.com/news/home/20240801708617/en/Health-Canada-approves-Celltrion%E2%80%99s-Steqeyma%C2%AE-a-biosimilar-to-Stelara%C2%AE-ustekinumab-for-the-treatment-of-multiple-chronic-inflammatory-conditions

2. Positive CHMP opinion for FYB202, an ustekinumab biosimilar candidate. Formycon. News release. July 26, 2024. Accessed August 5, 2024. https://www.fresenius.com/node/6872#:~:text=Fresenius%2C%20via%20its%20operating%20company,candidate%20to%20Stelara%C2%AE%20(ustekinumab)

3. Lupin announces successful completion of phase 3 trials for Lucentis® biosimilar. Lupin Limited. News release. August 5, 2024. Accessed August 5, 2024. https://www.lupin.com/lupin-announces-successful-completion-of-phase-3-trials-for-lucentis-biosimilar/

4. Reed JM. PBMs aren't opening access to lower-cost biosimilars. Reform is needed now. STAT. August 1, 2024. Accessed August 6, 2024. https://www.statnews.com/2024/08/01/pbm-biosimilar-drugs-ftc-action-needed-anti-competitive-practices/