Samsung Bioepis sued over trastuzumab biosimilar but win for Celltrion’s biosimilar Inflectra

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Samsung Bioepis sued over trastuzumab biosimilar but win for Celltrion’s biosimilar Inflectra

Biosimilares/General | Posted 28/09/2018 0 Post your comment

Roche’s Genentech has sued Samsung Bioepis regarding its trastuzumab biosimilar, but Celltrion has won its patent battle against Johnson & Johnson (J&J).

A district court has ruled that South Korean biotechnology company Celltrion can continue to market its biosimilar of J&J’s immunosuppressant drug Remicade (infliximab). Genentech, on the other hand, has sued Samsung Bioepis regarding its proposed trastuzumab biosimilar SB3.

On 4 September 2018, Genentech filed a complaint against Samsung Bioepis in the District of Delaware alleging infringement under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), of 21 patents. The lawsuit follows the filing of the biosimilar application for SB3, which references Herceptin (trastuzumab) and which Samsung Bioepis submitted to the US Food and Drug Administration (FDA) in December 2017 [2]. This is the fourth lawsuit regarding a biosimilar of Herceptin. Genentech has also filed suits against Pfizer [3], Celltrion and Teva, and Amgen, all of which are currently pending before Judge Sleet in the District of Delaware.

The US District Court of Massachusetts ruled on 30 July 2018 in favour of Celltrion, removing the final legal barrier to the continued marketing of Inflectra. The court stated that Celltrion’s biosimilar Inflectra did not infringe J&J’s patent, which covers particular compositions of cell culture, the material used to grow living cells that produce biologicals. J&J subsidiary Janssen sued Celltrion and the Pfizer subsidiary Hospira back in 2015, alleging that Inflectra infringed on a J&J patent [1].

By winning the last legal battle, Celltrion said it expects the autoimmune disease drug will further expand its market share in the US via its sales partner Pfizer. Pfizer has been selling Inflectra (infliximab-dyyb) in the US since November 2016. The biosimilar generated US$78.7 million in the US in the first half of 2018 while the originator biological posted sales of US$2.02 billion in the same period.

References
1. GaBI Online - Generics and Biosimilars Initiative. Janssen Biotech files lawsuits for infringement of cell culture media patent [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 28]. Available from: www.gabionline.net/Biosimilars/News/Janssen-Biotech-files-lawsuits-for-infringement-of-cell-culture-media-patent
2. GaBI Online - Generics and Biosimilars Initiative. FDA accepts applications for adalimumab and trastuzumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 28]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-applications-for-adalimumab-and-trastuzumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Roche sues Pfizer over Herceptin biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 28]. Available from: www.gabionline.net/Biosimilars/General/Roche-sues-Pfizer-over-Herceptin-biosimilar

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Source: Big Molecule Watch,Janssen vs Celltrion,The Investor