The long wait for Biogen’s European launch of Imraldi was due to its legal battle with Abbvie over Humira.

Biogen (NASDAQ:BIIB) and Samsung BioLogics announced their product Imraldi launched in the European Union (EU) on Wednesday (October 17), bringing additional competition to Abbvie’s (NYSE:ABBV) Humira.

Imraldi is a biosimilar to Humira and was approved for the same set of indications as its counterpart —14 complex autoimmune conditions — in the EU in August 2017. Those indications include rheumatoid arthritis, pediatric plaque psoriasis and Crohn’s disease among others.

This launch total’s Biogen’s portfolio to three anti-TNF biosimilars in Europe. Others consist of Benepali, referencing Amgen’s (NASDAQ:AMGN) Enbrel, and Flixabi referencing Johnson and Johnson’s (NYSE:JNJ) Janssen drug Remicade.

TNF inhibitor drugs stop inflammation, which is why they can be applicable to so many indications. It’s also Europe’s top grossing drugs at close to €8 billion from each year from 2011 to 2014, according to the press release.

Imraldi differs from Humira by offering a greater shelf life of three years, optimized patient experience and an innovation device while maintaining the same pharmacokinetics and efficacy.

The long wait for Biogen’s European launch was due to its legal battle of patents with Abbvie over Humira, as it was approved back in 2002.

The companies reportedly settled the patent dispute in April 2018, according to PharmaTimes, which led to the current launch.

Biogen was among other companies in legal disputes to launch Humira biosimilars. Amgen’s biosimilar, Amgevita, was launched in Europe on Monday (October 15) after finishing its legal battle last year.

Both Biogen and Amgen were granted patent licenses from Abbvie for the use of the biosimilars and run on a country-by-country basis. Biogen will be required to make royalty payments to Abbvie in return, while other details of the settlement were not announced.

Sandoz, a division of Novartis (NYSE:NVS), also plans to launch its own Humira biosimilar Hyrimoz in Europe after resolving patent disputes with Abbvie on October 11.

Humira is Abbvie’s top grossing product at US$5.18 billion out of its entire US$8.25 billion for key product revenue in Q2 2018. This was just a fraction of the sales the company reported on its 2017 financial report at US$18.4 billion.

Biogen calls itself one of the first global biotechnology companies. It has over 40 years of experience and was founded by multiple Nobel Prize winners, among other experts, in biotechnology. The company continues to develop a variety of drug in neuroscience with its pipeline including a variety of drugs from Alzheimer’s disease, to spinal muscular atrophy.

Investor takeaway

Biogen’s share price showed a mild decrease of 0.11 percent to US$338.23 over the trading period Wednesday.

TipRanks shows one analyst issued a note to investors the same day and reiterated “Buy” position with a US$470 price target.

Investors interested in developments on these biosimilars can look forward to the full year financial results of 2018 for all companies and to check back on revenue for the biosimilars, in addition to Abbvie’s Humira. Further development to Biogen’s launch in Europe and the US will be updated on the company’s site.

Don’t forget to follow@INN_LifeScience for real-time updates!

Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.



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