Dive Brief:
- The latest Drugs to Watch report from Clarivate Analytics Cortellis Competitive Intelligence identified eight emerging blockbusters newly-launched or poised to hit the market this year.
- The forecasted top seller, Roche's Ocrevus (ocrelizumab) for multiple sclerosis, was approved last month and is pegged to hit $3.3 billion in sales in 2021.
- Four of the predicted top sellers are cancer drugs, with an anticipated value of $5.6 billion combined in 2021, and six have been filed with expedited regulatory review, including breakthrough designation, priority review or fast track status.
Dive Insight:
Clarivate Analytics' Drugs to Watch 2017 report pulls on data from Cortellis Competitive Intelligence to predict the top sellers launched in 2017 that have potential for blockbuster status – sales of over $1 billion – by 2017.
Approval for the top contender, Roche's Ocrevus (ocrelizumab), was delayed in late 2016, but the company finally scored a OK in March for both relapsing and primary progressive multiple sclerosis, making it the first drug to treat the latter form of the disease.
Clarivate Analytics predicts an Ocrevus launch in the second quarter of 2017, stating the drug could "materially disrupt" the multiple sclerosis market. In the short term, market share gains are expected in second-line use, with first-line use in the medium term.
Dupixent (dupilumab), Sanofi and Regeneron's eczema drug, also secured Food and Drug Administration approval this March and is slated to launch in the second quarter. Clarivate Analytics predicts wide adoption based on good short-term outcomes in clinical trials and lack of alternatives. Sales could reach $2.8 billion in 2021.
The third on the list is durvalumab, AstraZeneca's checkpoint inhibitor, which will have to compete against the likes of Bristol-Myers Squibb's Opdivo (nivolumab) and Merck & Co.'s Keytruda (pembrolizumab).
The FDA has already accepted durvalumab's biologics license application for the treatment of bladder cancer, with a PDUFA data scheduled for the second quarter and a potential launch in the latter half of 2017.
A positive read-out from the comapny's closely watched MYSTIC study in non-small cell lung cancer will be crucial for the drug's long-term success. AstraZeneca recently adapted the study to look at both PD-L1 expressing lung cancers as well as "all-comers" in durvalumab as a monotherapy and in combination with tremelimumab.
Clarivate Analytics suggests the challenges faced by Opdivo in first-line non-small cell lung cancer and Merck's decision to only submit Keytruda for second-line approval could give durvalumab more options. Durvalumab's 2021 sales are predicted at $2.1 billion.
These predictions, of course, will depend on prevailing market conditions, drug approval timings (both of the top eight drugs and any competitors), and the possible changes to the FDA and the U.S. healthcare system under President Donald Trump.