Lotus Pharmaceuticals announced that it has obtained approvals for multiple European markets for its generic version of Celgene’s Revlimid®, which is indicated for hematological disorders including multiple myeloma. The Company believes this is the first approval of Lenalidomide 2.5, 5, 10, 15, 20 and 25mg in the European market.
Lotus Chairman Andrew Lin said that the Company filed Lenalidomide through decentralized procedure (DCP) with Iceland being the reference member state (RMS). The end-of-procedure confirmation (EOP) came yesterday with approval. Andrew believes Lenalidomide is a key asset for the group. He commented that “our filing for the European markets were confirmed in May last year, and the approval came within a year. We believe this is great news for patients, who will finally have access to a more affordable treatment. The product is also a critical part of a comprehensive portfolio of solid oral dosage oncology drugs developed by Lotus.”
Andrew further pointed out that Lenalidomide ANDA filing has triggered IP lawsuit in the US, which the company is carefully maneuvering through. Additionally, the Company already obtained approvals in Taiwan for some strengths. Based on IMS Midas data, European sales of Lenalidomide in 2017 were US$1,810 million. Launch of the product in Europe will occur once relevant and valid patents expire.