Boehringer Ingelheim's biosimilar demonstrates equivalence to Humira at Phase I
German family-owned drugmaker Boehringer Ingelheim has announced positive Phase I results of a study to prove pharmacokinetic bioequivalence of its biosimilar for Abbvie's (NYSE: ABBV) Humira (adalimumab).
The study, which was a randomized, double-blind, single dose, parallel-arm trial in healthy individuals, demonstrated bioequivalence of BI695501 to Humira. Safety, tolerability and immunogenicity were comparable among both treatment groups.
Peter Piliero, vice president of clinical development and medical affairs at Boehringer Ingelheim, said: "This is an important step towards our ultimate goal of providing new biosimilar therapeutic options to health care providers and patients. Boehringer Ingelheim is a pioneer in biotechnology with a long-standing history of more than 35 years; as a logical next step biosimilars are an important new area of focus for us."
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