Loading
Once a class of antibody such as PD-1 blockers is proven, later copies could be approved on smaller trials showing equivalence, forcing price competition and freeing patients and money for genuinely new drugs.
For mechanistic classes with multiple approved agents and well-understood pharmacology (anti-PD-1, anti-CD20, anti-HER2), regulators create a pathway between biosimilar approval and a full new-drug approval: approval based on pharmacodynamic equivalence and a single non-inferiority efficacy trial against an approved class member, with pricing expected to follow biosimilar dynamics. This ends the wasteful situation in which each of a dozen PD-1 antibodies runs its own placebo- or chemotherapy-controlled phase 3 in populations already known to benefit, while giving payers real competition within class. Capital that cannot earn novel-drug returns on copies moves elsewhere.
Shares Incentives reward me-too drugs and marginal gains, Trastuzumab, Trial design, endpoints and cost, Pembrolizumab.
Shares Shorter exclusivity for later-in-class drugs without added benefit, Challenges and opportunities in the PD1/PDL1 inhibitor clinical trial landscape, Incentives reward me-too drugs and marginal gains, Trial design, endpoints and cost.
Shares Challenges and opportunities in the PD1/PDL1 inhibitor clinical trial landscape, Incentives reward me-too drugs and marginal gains, Nivolumab, Pembrolizumab.
Shares Prices and value, Trastuzumab, Nivolumab, Pembrolizumab.
Shares Incentives reward me-too drugs and marginal gains, Prices and value, Nivolumab, Pembrolizumab.
Shares Trastuzumab, HER2, Nivolumab, PD-1.
Shares Incentives reward me-too drugs and marginal gains, Prices and value, Trastuzumab, Trial design, endpoints and cost.
Shares Prices and value, Nivolumab, PD-1, Pembrolizumab.