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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.
Shares Patent term extension scaled to proven survival gain, Challenges and opportunities in the PD1/PDL1 inhibitor clinical trial landscape, Incentives reward me-too drugs and marginal gains, Nivolumab.
Shares Incentives reward me-too drugs and marginal gains, Prices and value, Nivolumab, Pembrolizumab.
Shares Patent term extension scaled to proven survival gain, Incentives reward me-too drugs and marginal gains, Prices and value.
Shares Prices and value, Nivolumab, PD-1, Pembrolizumab.
Shares Patent term extension scaled to proven survival gain, Incentives reward me-too drugs and marginal gains, Prices and value.
Shares Prices and value, Nivolumab, Pembrolizumab.
Shares Incentives reward me-too drugs and marginal gains, Prices and value, Nivolumab, Pembrolizumab.
Shares Prices and value, Nivolumab, Pembrolizumab.