Biogen, Samsung accuse AbbVie of evergreening Humira patents to block biosims

AbbVie ($ABBV) is doing everything that it can to shield its top seller Humira from biosimilar competition. But now, the company is facing some pushback after Korea's Samsung Bioepis sued AbbVie to make way for its knockoff version.

Samsung and partner Biogen ($BIIB) filed suit in the U.K. to challenge AbbVie's patents on Humira. The partners contend that AbbVie "has been attempting to obstruct market entry of competing products by applying for a large number of overlapping patents around Humira, which could affect patient access to affordable medication," Samsung spokesman Mingi Hyun told The Korea Herald.

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A recent report from the IMS Institute for Healthcare Informatics shows that biosimilars could save health systems in the U.S. and Europe as much as $110 billion through 2020, and companies such as Samsung and Biogen want to cash in on that trend.

Samsung is aiming for 1 trillion won ($872 million) in sales by 2020, but the company needs to get around AbbVie's patent protections for Humira to hit that target. "We believe competition should take place in the market, and not through such misuse of the patent system," Hyun said.

But AbbVie isn't going down without a fight. The company "intend(s) to defend our intellectual property," AbbVie told FiercePharma, playing into its broader defense strategy. AbbVie is counting on strong patent protection for Humira to keep biosimilars at bay in the U.S. until 2020.

The company's formulation patent on Humira will expire in December of this year in the U.S. and in 2018 in Europe. Until then, AbbVie will try to get "maximum value" from the franchise through label expansions, new formulations and pricing wins, Suntrust analyst John Boris said.

But other analysts are not so optimistic about Humira's prospects. Sales of the drug will take a big hit starting in 2018, with revenues dropping from $16 billion at their peak in 2017 to $6 billion in 2022, Andrew Baum predicted last year in a note to clients.

To fill that void, North Chicago, IL-based AbbVie is looking to M&A and other products, including its hep C contender Viekira Pak. The company last year snatched up Pharmacyclics for $21 billion to get its hands on the drugmaker's blood cancer med Imbruvica.

And even though Viekira Pak missed sales expectations at home in Q4, the drug turned out a big performance abroad. The combo therapy brought in $357 million, beating analysts' estimates of $281 million. AbbVie sees "significant international growth" for Viekira Pak in 2016, with a full year of sales in Japan boosting revenues to about $2 billion, CFO Bill Chase said.

- read the Korea Herald story

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