- Hard at work developing its biosimilar pipeline, Samsung Bioepis has filed suit in a UK court against AbbVie over its efforts to stop Samsung launching a biosim of Humira, Reuters reports. The suit was filed in conjunction with Biogen, a minority shareholder in Samsung Bioepis.
- Humira is the best-selling drug in the world, generating about $14 billion in sales last year. It has nine immune-mediated indications in rheumatology, dermatology and gastroenterology, making it an attractive target for biosimilar competition.
- The composition patent for Humira expires in the US at the end of the year, and in Europe in October 2018. However, AbbVie has been busily filing new patents in an effort to shore up its protection from biosim competition.
Although this is the first lawsuit filed by Samsung Bioesis against AbbVie, it is not the first Humira patent suit AbbVie faces. More than a dozen companies have challenged AbbVie's Humira patent in various courts. Many of these suits allege AbbVie is trying to keep biosimilars out of the market using illegal tactics. For its part, AbbVie contents it is only protecting its intellectual property.
There's a lot at stake. For AbbVie, Humira represented more than 60% of total revenues last year. Samsung Bioepis is targeting $872 million in sales of biosimilars by 2020, according to Reuters.
Samsung launched a biosim version of Enbrel in South Korea last year and won approval in January in the E.U. Last Friday, the European Medicines agency recommended approval for its copy of Johnson & Johnson’s Remicade.
IMS estimates biosimilar competition could result in as much as $111 billion in saving in the US and top five European markets by 2020. Much of that will come from companies taking advantage of patent expiries on several blockbuster biologics.