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.
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.
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.
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.
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.
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.
7 DATA OVERVIEW
7 First-in-class drugs
7 Second-in-class drugs
7 Revenue and revenue forecasts
8 TRENDS IN FIRST-IN-CLASS DRUG DEVELOPMENT
8 Annual first-in-class FDA approvals total 177
10 A focus on blockbuster drugs
12 SPEED TO MARKET FOR FAST FOLLOWERS
12 Overall, many drugs lack in-class competition entirely
18 But when competition arrives, it is arriving more quickly
24 Does therapeutic modality affect time to in-class competition?
26 Disease prevalence may play a role in competitive interest
27 In-class monopoly times vary by therapeutic area
28 Biotechs enjoy longer monopolies than Big Pharma companies
31 HISTORICAL CASE STUDIES
31 Like-for-like comparisons within key markets
40 The race for first place has its rewards
45 About the author
8 Figure 1: FDA-approved first-in-class drugs, 2001–17
10 Figure 2: First-in-class drugs as a percentage of all drug approvals, 2001–17
LIST OF FIGURES
12 Figure 3: Most first-in-class blockbusters approved during 2001–15 lack in-class competition
19 Figure 4: Days to second-in-class competition, all cohorts, 2001–15
24 Figure 5: Chasing blockbusters: fast followers are getting faster, 2001–15
25 Figure 6: Neck-and-neck: antibody competition arrives a bit more quickly than small molecule competition, 2001–15
27 Figure 7: Rare disease drugs enjoy longer monopolies, 2001–15
28 Figure 8: In-class monopolies across key therapeutic areas, 2001–15
29 Figure 9: Biotech-developed drugs enjoy longer monopolies, 2001–15
32 Figure 10: Contrasting first-in-class cholesterol drugs: time to second-in-class entry
33 Figure 11: Intense competition for novel oral anticoagulants
34 Figure 12: Novel oral anticoagulant product sales, 2010–17
35 Figure 13: Newer migraine treatments compete out of the gate
36 Figure 14: In diabetes, class competition intensifies
37 Figure 15: GLP-1 product sales, 2005–17
38 Figure 16: DPP-IV product sales, 2006–17
39 Figure 17: SGLT-2 product sales, 2014–17
40 Figure 18: Comparing breast cancer treatment classes
LIST OF TABLES
14 Table 1: Some first-in-class blockbusters approved during 2001–15 lack branded in-class competition
20 Table 2: 2001–05 first-in-class cohort
21 Table 3: 2006–10 first-in-class cohort
23 Table 4: 2011–15 first-in-class cohort
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