With rising competition and declining prices, it has increasingly become important for biosimilar manufacturers like Biocon and Mylan to adopt an agile go-to-market strategy by forging global partnerships and collaborations, especially when the biosimilar in focus is none other than the high-value biologic – Humira, says GlobalData, a leading data and analytics company.
Biocon recently announced that its profit share on Humira (adalimumab) biosimilar Hulio, which is licensed to Mylan by Fujifilm Kyowa Kirin Biologics (FKB), was extended to global markets under an expanded in-licensing arrangement.
Shreya Brahmbhatt, Pharma Project Manager at GlobalData, says: “These partnerships also reflect that top biosimilar companies are focused on effectively growing in the international markets since the US adalimumab biosimilar market is closed until 2023 due to the existing patent protection of Humira.”
Humira is the world’s top-selling drug with reported sales of US$19.94bn globally in 2018, out of which US$13.69bn is from the US alone while the rest is from other international markets. Humira’s sales are currently protected from biosimilar erosion in the US.
However, it is notable that recently the growth of Humira has drastically declined in other international markets due to competition from biosimilars. AbbVie reported a 27.9% decline in Humira sales during Q1 2019 from the international markets when compared to Q1 2018. On the other hand, US sales of Humira increased by 7.1% in Q1 2019 compared to that in Q1 2018.
GlobalData expects Humira sales to be impacted strongly by biosimilar erosion in the EU, especially for immunology indications. According to the company’s latest report, ‘Rheumatoid Arthritis: Global Drug Forecast and Market Analysis to 2027’, adalimumab biosimilars will generate $807m sales in the 5EU by 2027 for this disease itself.
Biocon’s partnership with Mylan mainly targets existing and near term biosimilar opportunities. They have also co-developed two other high value biosimilar monoclonal antibodies (trastuzumab and bevacizumab), which are currently marketed globally for a number of oncology indications. Additionally, Biocon has another such strategic collaboration with Sandoz to co-develop biosimilar molecules for the immunology and oncology space, where Sandoz will lead commercialization in the US and the EU and Biocon will be responsible for commercialization in the rest of the world.
Brahmbhatt concludes: “Unlike generic small molecules, developing biosimilars is a costly affair and comes with a great amount of regulatory risks. In such a situation, generic biologic companies must manage price, volume and discounts with a high level of granularity. GlobalData believes that reducing the development cost is inevitable to remain competitive in the global biosimilars market, so the trend of companies with complimentary capabilities of development and commercialization getting together will likely continue during the coming decade.”