Intas Pharmaceuticals in-licenced exclusive global rights for the biosimilar of J&J’s blockbuster Monoclonal antibody Stelara® (Ustekinumab) from Korean company Dong-A ST and its Japanese partner Meiji Seika Pharma. Stelara® is approved for the treatment of multiple auto-immune conditions including moderate to severe plaque psoriasis, psoriatic arthritis and moderate to severe Crohn’s Disease. The ustekinumab biosimilar DMB-3115 is jointly being developed by Dong-A ST and Meiji Seika Pharma since 2013 and is currently in phase 3 development globally and is recruiting patients in USA and Europe as part of the ongoing trial (NCT04785326).
As part of the license agreement, Dong-A ST and Meiji Seika Pharma will be responsible for research and development of the biosimilar and Intas will have the global commercialization rights for all regions except Korea, Japan and a few Asian countries. On commercialization, Dong-A’s subsidiary DMBio, a CDMO will serve as the exclusive manufacturing partner of the drug and continue supplying to Intas. Dong-A ST and Meiji Seika will receive USD 10 million as upfront, followed by USD 95 million in milestone payments and double-digit royalties for sales of approved biosimilars by Intas. Intas’ UK based subsidiary Accord Healthcare will undertake the regulatory submissions and marketing in Europe and USA.
Stelara® brings in USD 6 to 8 billion annually in revenues to J&J and with patents expiring in 2023 and 2024 in US and EU respectively. Vying for this USD 8 billion market, multiple biosimilar candidates are in the pipeline. Interestingly, all ustekinumab biosimilars in development are being developed by Asian companies with Celltrion leading with its biosimilar candidate beginning phase 3 trial in January 2021, followed by Dong-A’s DMB-3115. Bio-Thera also has begun phase 3 trials in July 2021 and Samsung Bioepis’ and Neuclone’s candidates are in Phase 1 currently.
Accord Healthcare has an established network across US and Europe and has already commercialized two biosimilars – Trastuzumab and Pegfilgrastim in the European market. It has leveraged strategic partnerships for mid-to-late stage biosimilar assets to commercialize in the regulated markets. The Trastuzumab biosimilar was developed by Shanghai-based Henlius Biotech. The ustekinumab biosimilar partnership is well-timed since patent expiry is close and there are multiple competing biosimilar candidates in late-stage development. Accord reasserts itself as a global generic and biosimilar provider is an emphatic example of companies using the partnership route to de-risk biosimilar development and to expand their portfolios.