Patent expiry dates for biologicals: 2017 update

Abstract

Although small molecule drugs still dominate the global pharmaceutical market in terms of numbers, biologicals are making a significant dent. However, the high cost of biologicals is putting increasing pressure on healthcare budgets, thus opening the door to biosimilars. With patents on originator biologicals expiring, biosimilars are expected to take an increasing share of the biologicals market. In light of these facts, this paper gives estimated patent expiry dates for some of the best-selling biologicals.

What Does the Pipeline Promise about Upcoming Biosimilar Antibodies in Oncology?

“…The suppliers of most biologicals have not yet had to face competition from ‘generic' products. However, this is going to change gradually as a number of high-volume monoclonal antibodies lose their patent protection and defined periods of market exclusivity expire [15] (table 1). Therefore, many companies have launched biosimilar development programs.…”

“…The patents on Herceptin expired in Europe in July 2014 and will expire in the US in June 2019 [15]. …”

“…Biologicals now dominate the top 10 list of best-selling drugs in Europe: in 2017, 7 of the top 10 best-selling drugs were biologicals [2]. Moreover, several of the recently approved monoclonal antibodies in oncology including checkpoint inhibitors like nivolumab or pembrolizumab were predicted to become blockbusters in 2019 and 2020 [3,4]. Consequently, patient access to biologicals is often limited by high costs.…”

“…They are produced in a complex biotechnological process in living genetically modified microorganisms or cells; this is why they are much more expensive than other medicines. Biologicals now dominate the top 10 list of best-selling drugs in Europe: in 2017, 7 of the top 10 best-selling drugs were biologicals [2]. Moreover, several of the recently approved monoclonal antibodies in oncology including checkpoint inhibitors like nivolumab or pembrolizumab were predicted to become blockbusters in 2019 and 2020 [3,4].…”

“…Consequently, patient access to biologicals is often limited by high costs. The introduction of biosimilars for biologicals where the patents and exclusivity periods have expired to the market is an attractive way of reducing healthcare spending through price competition with the reference product [2]. …”