New FDA approval for Boehringer’s Cyltezo

The US Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), German family-owned pharma major Boehringer Ingelheim’s interchangeable biosimilar to Humira (adalimumab), to treat multiple chronic inflammatory diseases.

Humira is AbbVie’s (NYSE: ABBV) mega blockbuster drug which, while affected by biosimilars in Europe and elsewhere for much longer, has fending off such competition in the USA until last year.

There are currently a dozen or so approved biosimilar agents referencing Humira available in the USA, and a rapidly overcrowded market has emerged. In the first quarter of this year, global Humira net revenues dropped off 35.9% to $2.270 billion.