Watching Biosimilar Entrants Alongside Blockbuster Patent Expiry Countdown

by Ajay V. Patil

HUMIRA, the top selling drug and an anti-TNF-alpha monoclonal, had whopping USD 16 billion sales in year 2016. With its expected European patent expiration in October 2018, we review entry of its major biosimilars.

Primary European patent for AbbVie’s blockbuster drug HUMIRA® (adalimumab) expires in October 2018. It is the first fully human monoclonal antibody against TNF-alpha, approved by the U.S. Food and Drug Administration (FDA). Its approvals across ten important inflammatory indications including rheumatoid arthritis, psoriasis, Crohn’s disease and ulcerative colitis, moved Humira at the prime of top-selling pharmaceutical products list. Despite projected negative 3 percent growth rate over the next eight years, it is still expected to remain the top selling drug till 2024 (as stated by EvaluatePharma Review). Hence, its patent expiration is a major milestone for development of its biosimilars. First two biosimilar molecules of the drug with drastic price difference were introduced in India by Cadila and Torrent (in 2014 and 2016 respectively). But the race for EU and USA markets has just begun.

AbbVie and Samsung Bioepis announced that they had signed a licensing agreement. This approves Samsung’s European marketing partner, Biogen to launch their Humira biosimilar, Imraldi after October 2018. Like Humira, Imraldi has been approved for all ten indications. Imraldi is the second Humira-biosimilar approved in the Europe while Amgen’s Amgevita, was the first to be approved in March 2017 (for all Humira indications). Sean Harper, executive vice president of research and development at Amgen assured, additional treatment option in chronic inflammatory diseases as well. Both Samsung Bioepis and Amgen can start marketing these biosimilars only after October 2018, when the primary patent protection for AbbVie’s drug expires in the EU. However in the US, similar agreement prevents Amgen’s, launch until January 2023 and Samsung Bioepis’s launch until July 2023.

There are other TNF blockers like, Benepali (etanercept) and Flixabi (infliximab) which will have considerable impact on this situation. Such competitive scenario will plausibly stimulate affordable options in bigger markets. If not, the second wave of biosimilars is surely expected to hit the shores of inflammatory disease section.

References:
1. http://www.pmlive.com/pharma_news/new_eu_and_us_approvals_for_humira_biosimilars_1203495
2. http://www.pmlive.com/pharma_news/amgen_wins_european_approval_for_humira_biosimilar_amgevita_
1190009
3. https://pharmaphorum.com/sales-marketing/biogen-gets-go-ahead-eu-humira-launch-october/
4. https://news.abbvie.com/news/abbvie-announces-global-resolution-humira-adalimumab-patent-disputes-with-samsung- bioepis.htm

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