Teva Pharmaceutical Industries Limited (NYSE: TEVA) shares were increasing notably after a major regulatory development. Its shares jumped 5.62% in pre-market trading to $17.10. The rise came after the FDA in the United States declared that SELARSDI (ustekinumab-aekn) was completely interchangeable with the reference biologic Stelara (ustekinumab).
The FDA Gives SELARSDI Complete Interchangeability
Beginning on April 30, 2025, SELARSDI—which was unveiled in partnership with Alvotech—will be available in all of its reference product presentations. The clearance covers treatments for psoriatic arthritis, ulcerative colitis, plaque psoriasis, and Crohn’s disease in both adults and children. Expanding access to necessary biologic therapies at a reduced cost is made possible by the FDA’s confirmation of complete interchangeability.
Strategic Biosimilar Expansion Strengthens Teva’s Position
The launch of SELARSDI and EPYSQLI demonstrates Teva’s strategic focus on biosimilars. Given that several more biosimilar candidates are expected to be submitted in the future years, the company is well-positioned to become a significant player in the global biosimilar industry. These initiatives are in line with its long-term plan to spur growth by increasing access to reasonably priced, superior medications.
The Partnership Between Teva and Alvotech Gains Strength
With SELARSDI’s clearance, Teva and Alvotech’s ongoing collaboration is even more successful. The relationship has grown to encompass new medicines and formulations since its first agreement in 2020, which focused on the commercialization of five biosimilar concepts. Using its extensive marketing network and business acumen, the company spearheads commercialization in the United States, while Alvotech manages development and manufacture.
Pipeline Progress and Future Outlook
SELARSDI and SIMLANDI, a high-concentration, citrate-free biosimilar of Humira that was authorized in February 2024 and released in May, are the two biosimilars created under the Teva-Alvotech partnership that have so far been approved by the FDA with interchangeability. Additionally, according to the Biosimilar User Fee Act (BsUFA) timeframes, the FDA is now reviewing three Biologics License Applications (BLAs) for new biosimilars, with decisions anticipated in the fourth quarter of 2025.
