Collaboration with others can not only help biosimilar manufacturers develop their products faster but also get those products to market more effectively in a way that overcomes patent risks and other barriers to take-up, such as patient and clinician confidence in the product.
Biosimilars are medicines that seek to compete with originator biologic products. Biologics contain active substances derived from biological sources and are often large, complex molecules, such as antibodies.
Biologics are some of the most profitable and widely prescribed medicines. Adalimumab, used for the treatment of a number of conditions including rheumatoid arthritis and Crohn's disease, is currently the world's best-selling prescription drug. It is therefore not surprising that the biosimilar market in Europe is highly competitive.
Experience in Europe so far suggests that biosimilars are typically around 20% to 30% less expensive than originator products. Biosimilars therefore offer considerable cost savings to public health systems. As more originator products come 'off patent' – i.e. the patent which protects the product itself expires – biosimilar manufacturers will be seeking innovative ways to clear the path from any secondary patents, which often protect dosage regimes and methods for delivering the medicine, and achieve good market penetration.
Challenges faced by biosimilars in Europe
The European Medicines agency (EMA) is responsible for authorising and monitoring biosimilar medicines in the EU. While approval of biosimilars is far more progressed in Europe compared with the US – over 60 biosimilar medicines have been approved in Europe to date, compared with only 28 in the US – there are considerable differences in biosimilar uptake between European countries.
There is no singular reason for this, but there are a number of general, as well as local factors which play a part. One of the main reasons for the wide variation in adoption of biosimilars is that individual European countries take different approaches in how they procure medicines and negotiate prices. This may result in biosimilar medicines being more readily available and priced more favourably in one jurisdiction compared with its neighbours.
Pricing is a central issue. Greater competition is likely to drive down prices. When the patent exclusivity for adalimumab expired in October 2018, biosimilars entered the market shortly after and made a huge impact. By November 2018, it had been reported that AbbVie, the originator company, was offering discounts of up to 80% in parts of Europe to account for the increased competition. The more competition there is in one country or region, the more that prices are driven down, leading to increased uptake of that particular medicine.
Another factor is that the EMA does not regulate therapeutic interchangeability or substitution of an originator medicinal product by a biosimilar. It is instead left to individual EU member states and their national health authorities – such as the National Institute for Health and Care Excellence, NICE, in England – to determine whether a biosimilar should be prescribed instead of the originator product. This leads to a wide variation in take up of individual biosimilar medicines between countries.
Clinical practices and patient confidence, both of which are major drivers in the uptake of biosimilar medicines, also play a part. There are different clinical practices, including differing levels of confidence in the biosimilar products, as opposed to the originator biologic medicines. Patient confidence in the use of and compliance with prescribed medicines is vital, and is linked with the readiness of clinicians to prescribe biosimilar medicines. Patients are sometimes reluctant to accept a substitution to the biologic medicine with which they are familiar.
Patient confidence is also an issue in relation to the method of drug delivery. Biosimilar medicines are usually delivered by a device such as an auto-injector or prefilled syringe device, and are often administered by the patient themselves. Patients need to be confident that the delivery method is reliable, easy to use, convenient and that pain is minimised otherwise they can be put off the product. Design of the delivery method is therefore crucial, and ensuring that patients are familiar with the design can help in enabling patients to switch from one treatment to another.
Given these pressures, and the highly competitive market, it is essential that manufacturers remain competitive. Agile strategies with regards to market entry are paramount.
Engaging in joint venture and strategic partnerships can help biosimilar manufacturers get their product successfully to market. A number of businesses in the biosimilar industry have entered into joint ventures and co-development arrangements already. This is a particularly useful strategy in countries with high commercial potential for biosimilars, since it is these markets that will attract intense competition. It is fundamental for companies to get an edge and be the first to market.