As we reported last month, YL Biologics (a joint venture between Lupin’s subsidiary Kyowa and Yoshindo) recently submitted a New Drug Application (NDA) for Marketing Authorization of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for YLB113, a proposed biosimilar of Enbrel® (etanercept).

Yesterday, Lupin and Nichi-Iko Pharmaceutical announced that they have entered into an agreement for the distribution, promotion and sale of YLB113 in Japan.  According to Nichi-Iko, “[i]f Etanercept BS is approved, it will be sold as a Nichi-Iko product and Nichi-Iko will have exclusive rights to sell it.  One year after its introduction, Nichi-Iko will acquire the Marketing Authorization from Kwoya.”  Lupin stated that its “partnership with Nichi-Iko, takes [Lupin] a step closer to the launch of [its] first in-house developed biosimilar that is used to combat a range of severe autoimmune disorders.”  Lupin’s press release also notes that it has a pending regulatory application for YLB113 in Europe, as we reported recently.