UPDATED: Samsung Bioepis aims at AbbVie Humira patents in U.K. lawsuit

Incheon-based Samsung Bioepis has aimed a U.K. lawsuit at AbbVie's ($ABBV) Humira (adalimumab) patents as it races to bring a slate of biosimilars to the market that includes a biosim to the blockbuster rheumatoid arthritis therapy in the face of sharp-elbowed competition to do the same.

The lawsuit was filed on March 24 by Samsung Bioepis, a venture between majority partner South Korea's Samsung Group and Biogen ($BIIB) that is based in South Korea, according to a Reuters story.

The Korea Herald said Samsung Bioepis and Biogen have asked the U.K. High Court of Justice to nullify dozens of additional patents on Humira.

"Samsung Bioepis is taking this action to ensure that our affordable, high-quality biosimilars will reach the patients who need them most," Samsung Bioepis spokesman Mingi Hyun said in an email to FiercePharmaAsia.


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"We believe 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. We believe competition should take place in the market, and not through such misuse of the patent system."

An AbbVie official declined to comment on the lawsuit.

Samsung Bioepis has a lineup of 6 biosimilar candidates either approved in regulated markets such as a biosim to Enbrel (etanercept), or pending nods such as for Remicade (infliximab), which won a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) last week.

In development on the regulatory pathway are versions of Lantus (insulin glargine), Herceptin (trastuzumab) and Avastin (bevacizumab)--with another 7 molecules at early stages.

AbbVie CEO Rick Gonzalez

AbbVie CEO and Chairman Rick Gonzalez has vowed repeatedly to aggressively challenge copies of the drug that Reuters said had sales of $14 billion last year.

Gonzalez believes that a series of patents covering Humira will extend its status against a biosimilar until at least 2022, though exclusivity in the U.S. is slated to expire at the end of this year and in the European Union in April 2018.

That makes the move by Samsung Bioepis notable as both a challenge to an originator over complex patent laws and as a strategy to be first to market with a copy as other drugmakers have also challenged the series of Humira patents in court, including Tokyo-based Fujifilm Kyowa Biologics, Coherus Biosciences and Boehringer Ingelheim.

On the flip side, in January, the Canadian unit of U.S.-based Amgen ($AMGN) challenged Samsung Bioepis on a regulatory application for Brenzys, a biosimilar of Enbrel, but the application remains pending.

"We can confirm that the Patented Medicines Notice of Compliance (PMNOC) proceeding over Brenzys has been discontinued," Samsung Bioepis said. "We are unable to comment further."

- here's the story from the Korea Herald
- and a story from Reuters

Editor's note: This story was updated with comments from Samsung Bioepis.

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