Shorter exclusivity for later-in-class drugs without added benefit
The fifth PD-1 antibody that is no better than the first should not get the same market protection as the first. Exclusivity would shrink for copies that add nothing.
The mirror image of value-based extension: for the third and subsequent entrants in a mechanistic class, regulatory data exclusivity is reduced (for example from eight to four years) unless a head-to-head trial demonstrates superiority or a clinically meaningful advantage (toxicity, route, population) graded on a public scale such as ESMO-MCBS. This does not block approval, which remains safety- and efficacy-based, but changes the return profile of me-too development so that capital moves to unmet needs. Capital diverted from copies is the point; the risk is reduced price competition within class, which can be offset by an abbreviated pathway for biosimilar-like entrants.
- Incentives reward me-too drugs and marginal gains · The system pays the same for a drug that adds two months as for a cure, so companies race to copy rather than to cure.
- Prices and value · New cancer drugs routinely cost over $150,000 a year, often for months of benefit. Systems cannot afford them and patients go bankrupt.