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Mylan, Lupin Launch Etanercept Biosimilar in Germany


The launch marks the first European market entry for Nepexto.

Lupin Limited and Mylan have launched the biosimilar etanercept Nepexto in Germany for the treatment of several inflammatory diseases.

Germany is the first country in Europe to have Nepexto enter the market, according to Maximilian von Wülfing, managing director of Mylan Germany. Nepexto is the second immunology product to launch on the German market and the third etanercept biosimilar to receive regulatory approval in Europe, after the first was approved in 2016.

“This launch is a remarkable milestone for our biosimilar group, and we are glad that we are able to bring an affordable biosimilar to the European market through our partner Mylan. Biosimilars like Nepexto will play a vital role in expanding access to effective treatment for multiple therapies including rheumatoid arthritis,” Thierry Volle, president of the Europe, Middle-East, and Africa divisions at Lupin, said in a statement.

Nepexto received marketing authorization from the European Commission in May 2020 and was approved for all indications of the reference product, Amgen’s Enbrel, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis, and chronic severe plaque psoriasis.

Etanercept inhibits tumor necrosis factor, a cell signaling protein that contributes to inflammation. It was the first approved treatment of rheumatoid arthritis in Germany.

According to Amgen’s annual report, Enbrel’s sales for 2019 amounted to $5.2 billion globally, increasing by 4% over the course of the year.

Mylan, Lupin Partnership

Mylan and Lupin entered into a partnership agreement in 2018 to commercialize Nepexto. The agreement granted Mylan marketing rights for the biosimilar Europe, Australia, New Zealand, Latin America, Africa, and Asia.

Under the terms of the agreement, Lupin received an upfront payment of $15 million, and it will collect an equal share of net profits for Nepexto.

In 2014, Lupin entered into a joint venture agreement with its US subsidiary, Lupin Pharmaceuticals, and Yoshindo Inc.’s YL Biologics to develop and commercialize biosimilars, including Nepexto (YLB113), in Japan. YLB113 was approved for the Japanese market in 2019.

Other Mylan, Lupin Biosimilars

Nepexto is Lupin’s first biosimilar to receive European regulatory approval and Mylan’s fifth. Mylan has launched 3 products besides Nepexto in Germany, including Hulio (adalimumab), in partnership with Fujifilm Kyowa Kirin, and Ogivri (trastuzumab) and Fulphila (pegfilgrastim) in partnership with Biocon.

Additionally, Mylan, also in partnership with Biocon, is seeking approval for a bevacizumab biosimilar (MYL-1402O) that references Genentech’s Avastin. MYL-1402O is currently under review by the FDA and has a final decision date of December 27, 2020. Mylan has filed a European marketing approval application, as well.

Lupin Pharmaceuticals, is developing 6 biosimilars in addition to Nepexto, including molecules for ranibizumab, pegfilgrastim, filgrastim, denosumab, pertuzumab, and aflibercept.

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