Biosimilars are becoming a reality in the pharmaceutical industry. This is a consequence of many Phase III biosimilar studies having now been completed or nearing conclusion. Biosimilar developers have become highly adept at demonstrating biosimilarity with originator products in the clinical setting and regulators – in the EU and various other non-US markets at least – have become seasoned approvers of biosimilar drugs. Even the FDA is now approaching the regulatory process with more confidence. If the European biosimilars market has now entered a “commercialisation phase”, the US market is not far behind.
Among companies, several are more advanced than others. Samsung Bioepis, for example, is among those leading the pack, with two European biosimilar approvals – for Benepali (biosimilar etanercept) and Flixabi (biosimilar infliximab). The drugmaker has also confirmed FDA acceptance of its biosimilar infliximab application in the US. Flixabi is a biosimilar version of Johnson & Johnson and Merck & Co.’s Remicade (infliximab), for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. Biogen will be responsible for the commercialisation and distribution of the drug in Europe. Benepali, also known as SB4, is a biosimilar referencing Amgen’s Enbrel (etanercept), which has since been launched by Biogen in several EU countries.
In June, Mylan and Biocon announced that results from the Phase III HERITAGE study confirmed the efficacy and safety of MYL-1401O, the companies’ proposed biosimilar of Roche’s breast cancer drug Herceptin (trastuzumab). Herceptin, whose monthly cost is around $5500 in the US, last year generated more than $6.5 billion for Roche in global sales. The US patent for Herceptin expires in 2019, but Mylan plans to file for FDA approval in the coming months. Amgen and Pfizer are also among companies developing biosimilars of Herceptin.
In July, FDA advisors also backed approval of biosimilars of AbbVie’s Humira and Amgen’s Enbrel, which account for a combined $22 billion in annual revenue, for all conditions for which the therapies are authorised. Amgen’s proposed biosimilar of Abb- Vie’s Humira (adalimumab), to treat seven chronic inflammatory diseases for which the latter drug is cleared, including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis and plaque psoriasis.
Progress in its biologics pipeline “paves the way” for Novartis for five planned global launches of biosimilar products by 2020. Novartis could possibly launch biosimilar versions of AbbVie’s Humira (adalimumab), Amgen’s Enbrel (etanercept) and Neulasta (pegfilgrastim), Johnson & Johnson’s Remicade (infliximab) and Roche’s Rituxan (rituximab) within the next four years. The five drugs amassed combined sales of approximately $44 billion in 2015, according to Novartis.The company will pursue an “aggressive” strategy with the submission of 11 regulatory filings between 2015 and 2017. In May, the European Medicines Agency accepted the drugmaker’s submission for its Rituxan biosimilar in May. In July, an FDA advisory panel voted 20-0, recommending approval of Novartis’ GP2015 as a biosimilar candidate of Amgen’s Enbrel (etanercept) for all five conditions for which Enbrel is approved in the US.
Finally, about the same period, Amgen and Daiichi Sankyo announced a deal to jointly commercialise nine biosimilars for the Japanese market. The collaboration will include a number of late-stage assets, such as biosimilar candidates of AbbVie’s Humira (adalimumab), Roche’s Avastin (bevacizumab) and Herceptin (trastuzumab). Financial terms of the agreement were not revealed.