Biosimilar drugs are launched post patent expiry of a branded drug to provide patients with a cheaper version. Recently, in October 2018, a popular blockbuster drug Humira went off patent in Europe, paving the way for its biosimilars to hit the market. Humira is a monoclonal antibody drug termed Adalimumab prescribed in multiple inflammatory conditions including rheumatoid arthritis, psoriasis, and Crohn’s disease with a total of nine indications. Humira had been the best-selling drug for the past few years with a sale of approximately $18 billion in 2017, globally. This included a share of around $4.4 billion in the EU region, luring competitors in the biosimilar space to launch their products post patent expiry.
Competitors were quick to grab the opportunity. Multiple biosimilars were launched in the same month as soon as the Adalimumab went off patent last year. Three biosimilars – Amgen’s Amgevita, Sandoz’s Hyrimoz, and Samsung Bioepis’ Imraldi were launched immediately. Biogen/Mylan in collaboration with Fujifilm will soon follow in their footsteps with the launch of their biosimilar version named Hulio, as the European Medicines Agency (EMA) has already authorized marketing. Boehringer Ingelheim does not intend to launch its biosimilar version Cyltezo in the European market as of now, although it has already received marketing authorization.
Humira costs £500 million per year to the National Health Service (NHS) and is the major contributor to the overall healthcare cost. The launch of a biosimilar will help the NHS to cut down the cost to approximately £150 million, which is equivalent to paying additional 11,700 community nurses or providing 19,800 breast cancer treatments. As per the NHS, the drug is prescribed to more than 46,000 patients. To curb costs, it issued a guidance stating that 9 out of 10 patients should be switched to the best available alternative within three months of the biosimilar launch. It also stated that at least 80% of the total patients should be switched to the biosimilar alternatives within a year.
Biosimilar prices are likely to be 25% to 50% lower than the branded Humira, which roughly translates to a market of about $3 billion in Europe. It is estimated that Amgen’s Amgevita has an opportunity to turn a business of around $500 million in this space. The NHS is preparing the switch by involving patients, making them aware of the choice of alternative treatments, and assuring them that in case of a delay from “payers” during the treatment, they can switch back to their original biologic. Also, AbbVie agreed to give discounts as low as 80% to the patients, thus trying to make up the difference in the cost of treatment by biosimilars.
In the US, Humira contributed 70% of the total revenue generated, worth $12.4 billion in 2017. Humira’s patent in the US ended in 2016, but it is protected by about 100 patents around methods of treatment, drug formulation, and manufacturing, which made it very difficult for any competitor to create a biosimilar without infringement. The originator patent for Humira in the US will expire by 2023, and competitors such as Boehringer Ingelheim and Sandoz are already bidding to launch versions of their biosimilars.
Humira’s sales from the US will increase in the coming years. It is anticipated to reach approximately $20 billion by 2020, which will provide an immense opportunity for competitors to grab the biosimilar share. Competitors have enough time to plan their marketing strategies and prepare for contingencies if any. The patent expiry of Humira in the US will give the market a tough biosimilar competition as the patient pool for indications such as rheumatoid arthritis and psoriatic arthritis is enormous in the US. This provides a tremendous opportunity for competitors such as Boehringer Ingelheim who are trying hard to get the launch approval in the US. However, they have not utilized their marketing authorization in the EU region.