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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. 

What are the opportunities for biotech companies?   +

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.

How will consumer pressures drive demand for biosimilars?   +

Both payers and patients are fueling biosimilar development to expand access.

  • Payers, including national health authorities and private insurers, face ever rising medication costs and struggle to offer patients the most effective biologics on fixed budgets.
  • Patients wanting access to the most effective biologics, may have to pay all or a proportion of their medication costs (depending on reimbursement), which can impose a significant financial burden on families.

How ready are the world’s markets for approving biosimilars?   +

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.

What opportunities are there for clinical trial investigators?   +

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. 

What market indicators point to a growing biosimilars industry?   +

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.

  • Biologics have become a significant part of the global drug market with sales escalating from 10% in 2000 to 29% in 2014.1
  • The growth of the biologics sector is outpacing that of ‘traditional’ pharma (small molecule chemical drugs) and this is set to continue. As of 2015, biologics represent approximately 70% of the value of the world’s top 10 selling drugs.1 By 2025, biologics are projected to account for >70% of new drug approvals.2
  • Biologic patents worth approximately $69 billion are due to expire across major markets by 2018, with more likely to follow.1
  • In the EU, 21 biosimilars for seven different biologics have already been approved and are typically sold at a discount of 15–40% compared with branded biologics.3
  • Major markets, including the EU, the US, Canada, China, Australia, Japan, and South Korea, have established rigorous regulatory pathways for the approval of biosimilars. In total, around 24 countries have biosimilars approval frameworks in place.1
  • The US, the largest market for biologics, approved its first biosimilar in 2015 via the 351(k) pathway and the FDA has a number of applications awaiting approval.
What types of biologics are being targeted for clinical trials moving forward?   +

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

clinical trials chart

Source: Datamonitor Healthcare 2015


References   +

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.

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