Global Biosimilar Development Updates

Over the past week, biopharmaceutical developers from around the world provided updates on the development and availability of a number of biosimilar products and candidates.  Below are some highlights.

On May 2, Mundipharma, a global network of independent associated companies, announced that the trastuzumab biosimilar Herzuma® is now available in Europe, with the product now launched in both the UK and Germany and further launches across European countries anticipated in the coming months.  The press release states that the Mundipharma network has exclusive distribution rights in the UK, Germany, Italy, Ireland, Belgium, Luxembourg and the Netherlands to Celltrion’s Herzuma®, which was granted marketing authorization in Europe earlier this year following a positive opinion and recommendation by the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) in December 2017. The press release further indicates that Herzuma® is the third biosimilar to be marketed and distributed by the Mundipharma network in Europe, following Remsima® (infliximab) in 2015 and Truxima® (rituximab) in 2017.

Also on May 2, Formycon announced interim results for the clinical phase III trial for FYB201, a proposed biosimilar to Genentech’s Lucentis® (ranibizumab).  According to the press release, the primary endpoint in the trial was achieved, confirming comparable efficacy between FYB201 and the reference product in patients with neovascular age-related macular degeneration.  According to Formycon, the trial is expected to be completed in the second quarter of this year, and the data from trial will be part of the application for marketing approval with the U.S. FDA and the European Medicines Agency.  The press release states that Formycon’s “aim is the approval and launch of FYB201 as the first biosimilar to Lucentis® in the United States of America in 2020 and in the countries of the European Economic Area in 2022.”  Formycon further indicates that its development and distribution partner, Bioeq IP AG, is responsible for the phase III study and also holds the exclusive global marketing rights for FYB201.

On May 8, Lupin announced that in March 2018, YL Biologics (YLB), a Japan-based joint venture between Lupin’s subsidiary Kyowa and Yoshindo, had submitted a New Drug Application (NDA) for Marketing Authorization to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for YLB113, a proposed biosimilar of Amgen’s Enbrel® (etanercept), to treat indications for moderate to severe rheumatoid arthritis and juvenile idiopathic arthritis.  The press release states that “[t]his application marks the first biosimilar developed as part of the JV between Lupin and Yoshindo,” and that “[t]his filing also opens up other key markets like Europe, Canada, Australia, the Middle East, South East Asia and Latin America for this product.”  Lupin indicates that it “is also on course with its plans for filing in the US and is targeting a filing in FY 2019-20.”  Today, YLB and Yoshindo issued a similar press release stating that PMDA has accepted YLB’s filing.

Finally, today, Australian biosimilar developer NeuClone announced positive preclinical results for its biosimilar to Janssen’s Stelara® (ustekinumab), including X-ray crystallography analysis confirming identity and equal structural integrity of NeuClone’s biosimilar candidate and the reference product, in both primary amino acid sequence and 3-D folding.  According to the press release, this biosimilar is being co-developed with Serum Institute of India and is currently in process scale up to support planned Phase I clinical trials in 2019.

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