View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. Comment
March 4, 2019

Patent expiration explains pick-up in biosimilars market

We are set to see a continued increase in the number of biosimilar applications and approvals in 2019, says GlobalData.

By GlobalData Technology

The biosimilar drug market is soaring. Last year was a particularly exciting year for biosimilars, with the number of approved products within the European Union (EU) and the US continuing to grow.

Free Report
img

Spot leading innovative companies with GlobalData’s Innovation Scorecard

Innovation remains a necessity in a disruptive ecosystem, as continuous innovation allows companies to adapt, evolve, and grow through disruption. Using our in-house alternative datasets, we are excited to launch GlobalData’s Innovation Scorecard. This scorecard will allow clients to rank 3,500+ companies on their innovation activity, impact, and disruptive potential across geography, sector, and theme. The scorecard provides a data-driven framework to rank leading companies on the potential of their intellectual property (IP) portfolio. GlobalData’s Innovation Scorecard focuses not only on the activity of innovation in the organization but also on its impact and disruptive potential using the 3I framework: Intensity, Impact, and Ingenuity. The tool helps clients to identify the most innovative companies that are disruptive leaders and challengers and can create alpha for their portfolio using the insights driven by 19+ high-value KPIs. Download our report to find out more about this innovative tool. Key findings derived from this tool include:
  • Alphabet, Tencent, and Qualcomm are the top three innovative companies in the last 10 years
  • The scorecard finds Technology & Communications and Pharma & Healthcare as the two main sectors driving innovation
  • Loreal placed as ‘Disruptive Leader’ in the Consumer sector, while Revlon has been identified as a traditional laggard
  • Companies such as Etsy and H&M are challenging retail ‘Disruptive Leaders’ Amazon and Walmart
by GlobalData
Enter your details here to receive your free Report.

In 2006, Omnitrope (somatropin) was the first biosimilar approved in the EU, and since then, over 40 have been approved in the EU. However, the story in the US is markedly different: the US Food and Drug Administration (FDA) did not approve its first biosimilar, Zarxio, until 2015; this is due largely to ambiguous regulatory conditions and unresolved lawsuits regarding patent expirations.

Yet, by 2019, the FDA had approved 17 biosimilars, and the market is currently benefiting from a range of factors, such as a high number of patent expirations of blockbuster biologics, rising prevalence of chronic diseases and government cost saving initiatives. Thus, we are set to see a continued increase in the number of biosimilar applications and approvals.

Number of approved biosimilars in the EU and the US, 2006 – 2018

GlobalData: Drugs Database (accessed: 21 February 2019)

A critical event in 2018 involved the essential drug, Humira, losing patent exclusivity in the EU. For a number of years, AbbVie’s antibody drug has been the best-selling drug in the world, reaching over $19 billion in sales in 2018 alone. The patent expiration has promptly led to a surge of biosimilars attempting to enter the market and claim market share.

The wave of new biosimilars has resulted in national authorities announcing significant statements on the consequential financial savings that they could bring. For example, after negotiating deals with five key manufacturers on developing lower-cost forms of Humira, the NHS have claimed that they can save £300 million ($395 million) for the service’s most costly drug.

Blockbuster drugs

Other blockbuster drugs delivering over a billion dollars in revenue that have recently lost or are set to lose their patents in 2019 include Roche’s Rituxan (2018) and Avastin (2019), Eli Lilly’s Forteo (2018), and Novo Nordisk’s Levemi (2019), among many others. This heated market is clearly reflected in the number of deals involving biosimilars.

For example, 2018 saw a record in the number of deals, with total biosimilar deals increasing by 88% since 2012.

This year presents another exciting opportunity for biosimilars to make a significant impact on the pharmaceutical industry. With increased competition from accelerated biosimilar approvals and their introduction to the industry, we will see market conditions evolving, enabling patients to have more treatment options at a much lower cost than the original biologics.

Related Companies

Free Report
img

Spot leading innovative companies with GlobalData’s Innovation Scorecard

Innovation remains a necessity in a disruptive ecosystem, as continuous innovation allows companies to adapt, evolve, and grow through disruption. Using our in-house alternative datasets, we are excited to launch GlobalData’s Innovation Scorecard. This scorecard will allow clients to rank 3,500+ companies on their innovation activity, impact, and disruptive potential across geography, sector, and theme. The scorecard provides a data-driven framework to rank leading companies on the potential of their intellectual property (IP) portfolio. GlobalData’s Innovation Scorecard focuses not only on the activity of innovation in the organization but also on its impact and disruptive potential using the 3I framework: Intensity, Impact, and Ingenuity. The tool helps clients to identify the most innovative companies that are disruptive leaders and challengers and can create alpha for their portfolio using the insights driven by 19+ high-value KPIs. Download our report to find out more about this innovative tool. Key findings derived from this tool include:
  • Alphabet, Tencent, and Qualcomm are the top three innovative companies in the last 10 years
  • The scorecard finds Technology & Communications and Pharma & Healthcare as the two main sectors driving innovation
  • Loreal placed as ‘Disruptive Leader’ in the Consumer sector, while Revlon has been identified as a traditional laggard
  • Companies such as Etsy and H&M are challenging retail ‘Disruptive Leaders’ Amazon and Walmart
by GlobalData
Enter your details here to receive your free Report.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. A weekly roundup of the latest news and analysis, sent every Friday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Pharmaceutical Technology