Here are our picks for the top-5 biggest deals in the world of biosimilars in 2017:
5. Companies developing biosimilar products continue to establish partnerships to market and distribute the products on a regional basis. For example, Celltrion and Nippon Kayaku entered into an agreement under which Nippon Kayaku will sell Truxima®, Celltrion’s biosimilar of Rituxan® (rituximab), in Japan, thus adding to the portfolio of Celltrion biosimilars that Nippon Kayaku will market in Japan, including biosimilar versions of Remicade® (infliximab) and Herceptin® (trastuzumab). Similarly, Celltrion reached an agreement with Hikma Pharmaceuticals for Hikma to market Truxima® in the Middle East and North Africa. Like Nippon Kayaku, Hikma already had agreements with Celltrion for regional marketing of Celltrion’s infliximab and trastuzumab biosimilars. Amgen and Simcere Pharmaceutical Group announced an agreement for Simcere to market in China four biosimilars being developed by Amgen.
4. As we reported in March, Mylan reached a settlement agreement with Genentech and Hoffman-la Roche that provided Mylan with global licenses to commercialize its biosimilar to Genentech’s Herceptin® (trastuzumab). As part of the agreement, the parties agreed to settle IPR challenges to two U.S. Genentech patents, including patent no. 6,331,415 (the ’415 patent). As we reported previously (and here), the ’415 patent is one of the “Cabilly Patents” directed to foundational technology for biologic drug production. In December, FDA approved Mylan’s trastuzumab biosimilar under the trade-name Ogivri, and EMEA accepted Mylan’s resubmission of its application for marketing authorization for Ogivri in Europe.
3. As we reported in April, Fresenius Kabi and Merck KGaA announced that Fresenius would be acquiring Merck KGaA’s biosimilars business, which comprises Merck’s entire biosimilars development pipeline. According to Fresenius, the product pipeline is focused on oncology and autoimmune diseases. The deal closed in September, and earlier this month, Fresenius filed an application seeking marketing authorization for a biosimilar version of Humira® (adalimumab) in the EU, Fresenius’ first biosimilar regulatory filing arising out of the deal with Merck.
2. As we reported in February, Aurobindo Pharma Limited announced that it acquired four biosimilar products from TL Biopharmaceutical AG. The lead molecule in the acquired portfolio is a biosimilar to Genentech’s Avastin (bevacizumab), a biologic drug used in treating several different cancers.
1. As we reported in September, Amgen and Abbvie settled all pending patent litigation regarding AMJEVITA, Amgen’s biosimilar version of AbbVie’s Humira® (adalimumab). Under the settlement agreement, AbbVie granted patent licenses for the use and sale of the product worldwide, on a country-by-country basis. Amgen stated that it expects to launch its product in Europe in October 2018, and in the United States in January 2023. Humira® generated $16 billion in sales in 2016.
Have a Happy New Year, and we’ll see you in 2018!