September 3, 2020

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October 16 marks European patent expiry for AbbVie’s blockbuster anti—tumor necrosis factor drug, adalimumab (Humira), and multiple competitors stand ready to launch their biosimilar products on, or shortly after, that date. Alerts are available for users with active subscriptions. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice. “The vast majority of patients have been supportive of switching to the biosimilars,” he said, given the fact that benefits from cost savings directly benefit patient care in the UK health system. “In terms of actual benefit sharing,” Maréchal-Jamil said, “the EU national healthcare systems have an array of opportunities for immediate reinvestment in healthcare products and services but also looking at the looming and upcoming wave of innovation. The patent for Humira, the world’s bestselling drug, expires in Europe today – opening the door for a host of cheaper biosimilars to hit the market. AbbVie stock has risen by 27% over the past 12 months and is up 21% from an April dip, though it's ahead only about 4% for the year to date -- held in check by Humira patent-expiration … Experience shows that larger markets, such as the United Kingdom, Germany, and France, typically see the first launches, Maréchal-Jamil said. All rights reserved. The benefit sharing schemes, where they exist, have typically been devised so that patients in a given therapeutic area benefit from the biosimilar medicines choice.” These benefits may include additional nursing staff, educational programs, or supportive care. However, in Denmark, she explained, where current spending on 3 biologics—the brand-name adalimumab, trastuzumab, and rituximab—accounts for fully 6% of the nation’s pharmaceutical budget, stakeholders are keen to see strong competition. There is no warranty that the data contained herein is error free. © 2020 MJH Life Sciences™ and Center for Biosimilars®. It had estimated CD-specific sales of $1.9bn in 2016 across the seven major healthcare markets (7MM) of the US, France, Germany, Italy, Spain, the UK, and Japan. In most countries, you can have a country-wide discount, followed by further discounts in regions, cities, or individual hospitals. However, while some markets may gain access to the adalimumab biosimilars and these associated benefits right away, companies may elect to bring their products to markets at different time points across the European Unio. Given the high cost of brand-name Humira, stakeholders are hoping for a substantial discount on these biosimilars relative to the price of the originator, and speculation has been swirling as to how low the list prices of the biosimilars could go. The brand-name Humira will also be allowed to issue a bid in the tender process. What is clear, however, is that the European market sees reinvestment in healthcare services as a primary goal of a switch to biosimilar adalimumab. Visit the Subscription Options page for details on plans and pricing. With the potential to market two blockbuster therapies for the treatment of CD by 2026, AbbVie is well positioned to remain a CD market leader for the foreseeable future. However, Humira is set to face competition from biosimilars in the near future, with approvals from the European Commission (EC) and US Food and Drug Administration (FDA) for Amgen’s adalimumab biosimilar Amjevita in March 2017 and September 2016, respectively. Case Name Date; Celgene Corporation v. Mylan Pharmaceuticals Inc. 2020-01-03: CELGENE CORPORATION v. MYLAN PHARMACEUTICALS INC. 2019-12-31: CELGENE CORPORATION v. In the United Kingdom, in particular, dedicated efforts have been underway to make the most of savings provided by the arrival of biosimilar adalimumab. However, they are ineffective in preventing flare-ups, and the side effects associated with their long-term use mean that they cannot be used for maintenance therapy in CD. CD occurs most commonly in the lower part of the small intestine and in the large intestine, although the location and severity of the disease differs by individual. Humira’s rise to the top of the anti-tumour necrosis factor (anti-TNF) class is partly due to its convenient administration as a subcutaneous injection, as well as AbbVie’s extensive marketing. The companies will be notified as to which regions of the country they have been awarded on November 1. Warwick Smith, director general of the British Biosimilars Association, told The Center for Biosimilars® in an interview that “I think we will see a number of companies ready to launch at patent expiry,” and added that the United Kingdom, among EU member states, is likely to see some of the first launches, due in large part to lessons learned from past biosimilar experience. This leads to a wide variety of discounts across the continent and even across countries.”. GlobalData (2017). By using our website you are consenting to our use of cookies in accordance with our, See patent lawsuits and PTAB cases for HUMIRA, Tumor Necrosis Factor Receptor Blocking Activity, LOE / Major Patent Expirations 2020 - 2021, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives, Celgene Corporation v. Aurobindo Pharma Limited, Massachusetts Eye and Ear Infirmary (Boston, MA), PRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2015)4704 20170703, PRODUCT NAME: TRASTUZUMABAS IR REKOMBINANTINE ZMOGAUS HIALURONIDAZE; REGISTRATION NO/DATE: EU/1/00/145/002 20130826, PRODUCT NAME: KEVZARA - SARILUMAB; AUTHORISATION NUMBER AND DATE: EU/1/17/1196 20170627, PRODUCT NAME: TRASTUZUMAB EN RECOMBINANT HUMAAN HYALURONIDASE; REGISTRATION NO/DATE: EU/1/00/145/002 20130826, PRODUCT NAME: SARILUMAB; REG. To seek professional advice and independent confirmation before considering acting on any of the severity. As provided by public sources nor are attempts made to provide legal or investing advice applicant are. Manufacturing information awarded on November 1 formulation and manufacturing information allowed to issue bid. 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