Background

Competition from drugs in the same class (with the same mechanism of action and treating the same disease) presents a clear challenge to a first-in-class market entrant. And the speed with which these competitors arrive impacts market dynamics, commercial strategies, and, increasingly, drug prices. Therapies that enjoy extended monopolies as sole entrants in a particular class have greater commercial flexibility in negotiating with payers. Multiple drugs in the same class give payers better leverage with which to negotiate rebates and discounts with drug companies. Here, the lengths of in-class monopolies are examined for the biopharmaceutical industry’s best-selling first-in-class therapies launched in the US since 2001 to determine if the speed to in-class competition is increasing, decreasing, or remains the same, and how in-class monopolies vary based on the type of drug, therapeutic area, or type of drug developer.

During 2001–17, the FDA approved 466 new molecular entities through its CDER

Of the 466 drugs approved by the US Food and Drug Administration (FDA) through its Center for Drug Evaluation and Research (CDER), 177 were described as first-in-class drugs as determined by their mechanism of action and therapeutic indication. In all, 77 of these 177 drugs have either achieved blockbuster status (>$1bn worldwide sales) or are projected to do so.

Second-in-class drugs are now reaching the market more quickly

This set of blockbuster first-in-class drugs was segmented into three cohorts based on approval date (2001–05, 2006–10, and 2011–15). It was found that roughly half of the drugs in each cohort face no in-class competition.

For the subset of drugs that do face in-class competition, the time to second-in-class drug approvals shrank from 2001–05 to 2006–10, and again from 2006–10 to 2011–15. This shows that fast followers are reaching the market more quickly, on average.

There were more first-in-class blockbuster drugs approved during the 2011–15 timeframe than in the other two cohorts combined, although it is unclear whether this marks a fundamental shift away from me-too drug development, or is due to the increasing price of drugs more generally (and thus the fact that more drugs exceed the $1bn threshold than in the past), or is a consequence of current regulatory incentives and a more accommodating regulator.

Most first-in-class blockbuster/potential blockbuster drugs approved during 2016–17 do not yet face in-class competition, and were excluded from this cohort analysis because they have been on the market for only a short time.

Blockbuster first-in-class drugs were also segmented by type of drug, type of developer, therapeutic area, and disease prevalence

There was no material difference in time to second-in-class competition between small molecule therapeutics and MAbs (there were insufficient data to measure other therapeutic modalities, such as non-MAb biologics, peptides, or fatty acids).

Drugs brought to market by biotech companies maintained in-class monopolies much longer on average than drugs brought to market by Big Pharma or specialty pharma companies.

Drugs that treat rare diseases maintained in-class monopolies much longer than drugs that treat primary care or specialty indications.

Among therapeutic indications where sufficient data were available to draw conclusions, anti-infective drugs enjoyed the shortest in-class monopolies, while autoimmune drugs enjoyed the longest in-class monopolies.

Recently launched and highly anticipated blockbuster drug classes have featured accelerated in-class competition compared to prior decades

This phenomenon can be illustrated across both primary care and specialist categories in multiple therapeutic areas.

In the cardiovascular space, the years-long wait for second-in-class statins to control high cholesterol contrasts with the weeks-long wait for a second inhibitor of PCSK9 for individuals whose cholesterol is not controlled by statins.

The clot-preventer Plavix enjoyed a nearly 12-year monopoly before facing second-in-class competition from Effient in 2009. In contrast, newer oral anticoagulants arrived on the market as a group, with Pradaxa enjoying a monopoly of less than a year before rival Xarelto was approved.

Two classes of drugs that represented advances in migraine treatment, triptans and CGRP inhibitors, can be similarly compared, as can different drugs to treat breast cancer and diabetes. In each of these cases, newer drug classes faced in-class competition faster than older drug classes in the same disease areas.