On February 23, 2024, a press release by partners Alvotech and Teva revealed that their long journey to obtain an approval for their adalimumab biosimilar was complete. The FDA designated Simlandi® (adalimumab-ryvk), a high-concentration formulation, as interchangeable with Humira®, making it the first interchangeable version of this most commonly used formulation.
The drug is approved for all of the major indications covered by the 9 adalimumab biosimilars available today in the US.
Dr. Eric Hughes, Executive Vice President Global R&D and Chief Medical Officer at Teva, remarked, “This approval marks an important milestone for Teva and Alvotech’s partnership to collaborate on seven biosimilars and expand the availability, access, and uptake of biosimilars in the US.” Teva will market Simlandi, in addition to the ustekinumab biosimilar candidate that is currently at review with FDA and five other biosimilars in the pipeline.
Alvotech had initially hoped to introduce Simlandi with the large wave of launches in July 2023, but manufacturing plant problems resulted in two complete response letters. The interchangeability approval was supported by a phase 3 switching study in patients with plaque psoriasis. Apparently, the approval of Simlandi upends other manufacturers’ plans for receiving the exclusive interchangeability designation for the high-concentration formula. Boehringer Ingelheim earned the initial interchangeability designation for the low-concentration version, but that exclusivity has expired.
A launch date for the product was not announced, but we expect the biosimilar to enter the fray before the end of June. Alvotech’s biosimilar is already available in Europe and Canada.
