Here are our picks for the top-five most significant foreign biosimilar market developments in 2018:
1. Shake-up In Europe’s Adalimumab Market
As a result of litigation and resulting global settlements, several adalimumab biosimilars launched in Europe this year. In October 2018, Amgen, Sandoz, Samsung Bioepis and Mylan launched adalimumab biosimilars, Amgevita, Hyrimoz, Imraldi and Hulio, respectively. Pfizer, Momenta and Fresenius entered into global settlement agreements with AbbVie that allow them to launch their adalimumab biosimilars upon EMA approval. As a result of biosimilar competition, AbbVie has reportedly dropped the price of HUMIRA by 80%.
2. Multiple Pegfilgrastim Biosimilar Approvals in Europe
The European Commission granted marketing authorization for four pegfilgrastim biosimilars including Coherus’ Udenyca, Accord Healthcare’s Pelgraz, Mundipharma’s Pelmeg, and Sandoz’s Ziextenzo.
3. Multiple Biosimilar Launches in Korea
In 2018 in Korea, GC Pharma launched Biocon’s insulin glargine biosimilar,GLARGIA; Daewoong Pharmaceutical launched Samfenet, its trastuzumab biosimilar; and LG Chem launched its entanercept biosimilar, Eucept.
4. The First Etanercept Biosimilar Launches in Japan
Mochida Pharmaceutical and AYUMI Pharmaceutical launched the first etanercept biosimilar in Japan in 2018. A second etanercept biosimilar may not be too far behind. In 2018, YL Biologics (a joint venture between Lupin’s subsidiary Kyowa and Yoshindo) submitted an NDA for the etanercept biosimilar, YLB113, and Lupin and Nichi-Iko Pharmaceutical entered into an agreement for the distribution, promotion and sale of YLB113 in Japan.
5. The First Adalimumab BLAs Are Filed In China
China’s National Medical Drug Administration accepted Bio-Thera’s BLA for BAT1406, its proposed adalimumab biosimilar and Innovent Biologics’ BLA for its adalimumab biosimilar, IBI303.
