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22 Feb 2016

Humira, (adalimumab), Abbvie – 2016 Biggest Patent Expiry and Biosimilar entry

Rheumatoid arthritis treatment Humira has long been a crucial source of revenue for AbbVie: the world’s biggest-selling drug accounted for 63% of its 2014 revenue at $12.54 billion. Sales remained strong in Q1 2015, but took a hit in Q2, with a 7.6% fall from the previous year.

Although Humira’s US patent is not set to expire until 2016, Zydus Cadala launched a biosimilar in India for a fifth of the US price in late 2014, and Janssen’s Remicade is believed to already be impacting Humira sales. AbbVie investors are hopeful that the challenge of obtaining regulatory approval in the US for a biosimilar will prevent additional rivals in the country until towards the end of the decade.

In India, Torrent Pharma also announced in January 2016, the launch of biosimilar adalimumab in India under the brand name ‘Adfrar’.

Amgen, the California drugmaker filed for biosimilar application application, ABP 501 to USFDA. but earlier this month, the U.S. Patent and Trademark Office shut down its challenge to Humira’s patents. That means it’ll be up to Amgen to upturn the IP shields in court, something it says it plans to do. However, that process could delay the biotech’s plans to market its copy by 2017.

Although the basic U.S. compound patent for Humira expires in late 2016, the additional patents expire between 2022 and 2034,  AbbVie will pursue litigation to try to keep copycat versions-also known as “biosimilars”—off the U.S. market until at least for next 3-4 years.

Humira Global Sales

  • 2014: 13.02 Billion
  • 2013: 11.10 Bilion
  • 2012: 9.3 Billion
  • 2011: 7.9 Billion
  • 2010: 6.5 Billion
  • 2009: 5.5 Billion

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