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AbbVie deal with Amgen sets biosimilar Humira launch dates

Agreement will see Europe access the drug over four years earlier than patients in the US

Amgen

After months of legal wrangling, AbbVie has reached a deal with Amgen that will see the latter’s biosimilar version of blockbuster drug Humira launched next in Europe, but not until 2023 in the US.

The two companies have now ended their patent infringement litigation over Humira (adalimumab) - a TNF inhibitor used to treat rheumatoid arthritis and several other immunological diseases that is the world’s biggest-selling pharmaceutical product.

As a result of the settlement, AbbVie has granted non-exclusive licenses to Amgen that will allow it to launch its biosimilar from October 16, 2018 in Europe, and from January 31, 2023, in the larger US market, which accounted for almost $6bn of the drug’s $9bn turnover in the first six months of the year.

The drug still accounts for two-thirds of AbbVie’s revenues although it has made strenuous efforts to diversify into areas such as cancer and hepatitis C, and has high hopes for new launches such as blood cancer therapies Imbruvica (ibrutinib) and Venclexta (venetoclax).

Amgen has agreed to pay royalties on sales of its biosimilar, and AbbVie general counsel Laura Schumacher said in a statement that the deal “achieved the balance between protecting investment in innovation and providing access to biosimilars, which will play an important role in our health care system”.

Amgen secured approval in Europe for its biosimilar under the Amgevita brand name in March and in the US as Amjevita a year ago, said that the drug will be one of its first biosimilar launches.

“This agreement will allow us to secure a strong foothold in the $4bn European adalimumab market," said Scott Foraker, who heads up the company’s biosimilar unit. The settlement comes shortly after Amgen granted a license to Simcere to co-develop and sell four of its biosimilar candidates in China.

Aside from Amgen, Samsung Bioepis has also been granted approval for its Imraldi Humira biosimilar in Europe, while Novartis’ Sandoz unit has filed its version with the EMA. In the US, Boehringer Ingelheim is the second biosimilar developer to claim FDA approval after Amgen, getting clear for its Cyltezo version last month.

Article by
Phil Taylor

29th September 2017

From: Sales

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