April 19, 2024

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[THE INVESTOR] Samsung Bioepis said on Aug. 25 it has cleared the final regulatory hurdle to sell its copy version of AbbVie’s Humira -- the world’s top-selling drug in its category -- in Europe.

The European Medicines Agency has granted approval for Samsung Bioepis’ Imraldi for the treatment of multiple autoimmune diseases including rheumatoid arthritis, Crohn’s disease and ulcerative colitis.

The green light will put further pressure on AbbVie, which relies on Humira to generate over 60 percent of its total revenue -- US$16.1 billion in 2016. Amgen already received the approval for its Humira knockoff in March.

With this approval, the five-year-old biopharmaceutical firm has become the first company to have approved biosimilars for all three top-selling tumor necrosis factor inhibitors -- representing some of the EU’s largest drug expenditure of an estimated US$9 billion. In 2016, the firm received EU approval for Benepali, its version of Amgen’s Enbrel and Johnson & Johnson’s Remicade copycat Flexabi.

“The approval is a meaningful step for Samsung Bioepis as it improves accessibility to patients, enabling us to bring Humira in addition to Benepali and Flixabi to Europe,” said Ko Han-sung, CEO of Samsung Bioepis, in a press release.

Imraldi will be sold by Biogen which set up Samsung Bioepis with Samsung BioLogics in 2012.

However, since Humira is protected by patents until October 2018, copy versions cannot be launched immediately.

“It’s too early to talk about the exact release date of Imraldi. But we expect that a UK patent court’s ruling that two of AbbVie’s Humira patents are invalid will have a positive impact on the product launch in Europe,” a Samsung Bioepis official said.

In March, the UK High Court of Justice ruled in favor of Samsung Bioepis, judging that AbbVie’s indications pertaining to rheumatoid arthritis, psoriasis and psoriatic arthritis were not patentable. Still, AbbVie has numerous other patents to stave off the introduction of Humira alternatives.

Samsung Bioepis has one of the strongest biosimilar pipeline including five other candidates in addition to the EMA approved Lantus copycat and its version of Herceptin, awaiting imminent approval.

While seeking to bolster its global foothold with the biosimilar versions, the company has started exploring ways to become an original drug maker. On Aug. 21, Samsung Bioepis said it has forged a “risk-sharing partnership” with Japan’s Takeda Pharmaceutical to develop novel biologic drugs, starting with a treatment for acute pancreatitis.

By Park Han-na (hnpark@heraldcorp.com)