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Once two drugs of a kind exist, a third should have to prove itself against the best of them, not against an outdated comparison, so patients and payers learn which is actually better.
Regulators (or payers, through reimbursement rules) require that registration trials for the third and later entrants in an established mechanistic class use the best available in-class agent as the active comparator, or at minimum include a randomised head-to-head arm. Exceptions apply where the new agent addresses a population the incumbents do not. This makes me-too development more expensive and more informative at once: it either yields comparative evidence patients need or diverts capital to novel mechanisms.
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 Incentives reward me-too drugs and marginal gains, Trial design, endpoints and cost, Pembrolizumab.
Shares Incentives reward me-too drugs and marginal gains, Nivolumab, Pembrolizumab.
Shares Challenges and opportunities in the PD1/PDL1 inhibitor clinical trial landscape, Incentives reward me-too drugs and marginal gains.
Shares Challenges and opportunities in the PD1/PDL1 inhibitor clinical trial landscape, Incentives reward me-too drugs and marginal gains.
Shares Challenges and opportunities in the PD1/PDL1 inhibitor clinical trial landscape, Incentives reward me-too drugs and marginal gains.