A number of indicators within the industry point to the continued growth of biosimilars and opportunities to conduct clinical trials to bring them to market.
Biologics represent an increasing proportion of total sales and new drug approvals creating a pipeline of opportunity for biosimilar development. As these originator biologics go off patent, biotech companies are financially motivated to develop biosimilar versions to capture a share of this market. While a costly investment, development of biosimilars should have a lower risk profile than developing novel drugs, because the end result is a close copy of an approved drug that is already in demand. Seizing the opportunity, both large and small companies around the world are working to be among the first to launch new biosimilars, recognizing that the market will probably only sustain a small number of biosimilar competitors for each originator biologic. Those interested in biosimilar development now include many manufacturers of important originator biologics.
Both payers and patients are fueling biosimilar development to expand access.
Responding to the need to increase access to biologics, regulatory authorities in larger markets have already established rigorous biosimilar approval pathways consistent with international standards. Other smaller markets are following their lead in anticipation of the arrival of biosimilar candidates.
Just as the small-molecule generics market matured and continues to grow, the biosimilars market is poised to do the same. A number of originator biologics have already gone off patent and marketed biosimilars are starting to drive prices down. More biologics are approaching patent expiry and new biologics will continue to be introduced over time, creating a pipeline of opportunity for clinical trial investigators that is likely to be sustained for years to come.
The biosimilar market’s true potential can be illustrated by two simple measures: the substantial growth of biologics in recent years and the number of expected patent expiries for originator biologics.
Initially, Phase III biosimilar trials were conducted on therapeutic protein products (such as filgrastim, epoetin, and somatropin), but more recently the focus has shifted towards monoclonal antibody candidates, as shown in the figure below.3
Cumulative major market Phase III clinical trials of biosimilars by molecule type 2000–2015
Source: Datamonitor Healthcare 2015
1. Sackman J, Kuchenreuther M. The bullish outlook for biosimilars. BioPharm International (2015) 28 (2). http://www.biopharminternational.com/bullish-outlook-biosimilars. Accessed 15 October 2015.
2. Berkowitz SA, Engen JR, Mazzeo JR & Jones GB. Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars. Nat Rev Drug Discov (2012) 11:527–540.
3. Somers G. Biosimilars peer set overview [Ref code: DMKC0136967]. Datamonitor Healthcare 2015; www.datamonitorhealthcare.com.