Biosimilar Bytes

What do nanomedicines and biosimilars have in common? Not much, one might think. At the 2022 annual meeting of the Academy of Managed Care Pharmacy, we learned a new term: nanosimilars. John Hertig, PharmD, MS, Associate Professor at Butler University described nanomedicines as complex, non-biologic pharmaceuticals that range up to 1,000 nm in size. They include the liposomal drug formulations and were first available in the middle of the 20th Century. These drugs, like biologics and biosimilars, are highly dependent on the manufacturing process—any changes can affect the critical characteristics of the medicine. Copies of nanomedicines (> 50 are approved in the US), like biosimilars, are inexact, and phase 4 outcomes trials are required to confirmed the equivalency of these nanosimilars to the originator product.

Formycon AG purchased the operational assets of Bioeq, part of its partnership with ATHOS in Europe. Formycon and Bioeq are working with Coherus Biosciences to commercialize a biosimilar version of ranibizumab (FYB 201), which is awaiting FDA approval. Formycon and Bioeq are also collaborating on a biosimilar version of ustekinumab (FYB 202). The phase 3 study for FYB 202 should be concluding presently.

Alvotech and AbbVie have signed an agreement that clears all patent litigation for marketing its adalimumab biosimilar in Europe. On March 8, Alvotech and AbbVie agreed to a royalty-based licensing agreement that allows Alvotech to launch AVT02 in the US in July 2023, contingent of course on FDA approval.

A new study by European researchers affirmed the safety and efficacy of switching among the reference product infliximab (Remicade®), and the biosimilars Inflectra® and Renflexis® in patients with inflammatory bowel disease. A total of 176 patients were assigned to one of three groups: (1) patients who underwent two infliximab switches, from the reference product to one biosimilar and then to the other biosimilar; (2) patients who switched from one biosimilar to the other; and (3) patients who switched between Remicade and one biosimilar. The researchers found no significant differences, 12 months after the final switch, with regard to clinical remission, laboratory results (e.g., C-reactive protein levels), treatment persistence, or in safety parameters, regardless of infliximab switch group. The authors noted that all patients were in remission at the time of study entry (switching was not attempted during a clinical relapse or flare-up of disease).

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