US regulator stays firm on knockbacks

One of the most notable aspects of the FDA's track record on complete response letters is that the agency seems to hand out a remarkably similar number each year. This much is true for the last five, with 2022 seeing 34 rebuffs, bang on the five-year average. There was a slight uptick in the peak pandemic year of 2020, when delays in manufacturing plant inspections presumably peaked, and this issue remained live last year. Those hit by the FDA's ongoing Covid travel restrictions included Alvotech and Teva with their Humira biosimilar, the China-based cancer players Junshi and Hutchmed, and UCB, whose US launch of an important new growth driver, the psoriasis drug bimekizumab, was painfully delayed. This factor should fade in 2023, and the numbers below do not point to any particular tightening up of reviews at the US regulator. The clampdown on accelerated approvals is more likely to crimp the volume of novel agents hitting the market in the future. Still, it is always important to remember the big caveat of this analysis, which is that it relies on company disclosure. Private developers and some larger groups might not always feel obliged to announce a knockback.