15 Years of Biosimilars: Lessons Learnt and What’s Next

As we pass the 15th year mark since the world’s first official biosimilar was approved in the EU, the biosimilar landscape continues to evolve and expand globally. Globally, the increasing use of biosimilars is expected to reduce spending by approximately $160 billion between 2019 and 2023.

Biologics are a class of naturally derived drugs, which have increasingly driven the discovery of innovative therapies for a range of diseases (e.g. immune-related, oncology and rare diseases). Whilst at the forefront of medical research, biologics are expensive to develop, leading to high treatment costs – in 2020, ~$300 billion was spent globally on biologics. As such, there is a need to make biologics more affordable and widely accessible – a need exacerbated by the financial impact of COVID-19.

Biosimilars play a key role in improving the affordability and accessibility of biologics. Defined as highly similar biologic products, that have the same safety, quality, and efficacy as their reference biologic. However, they are cheaper and faster to develop, and in some markets can cost up to 70% less than the original biologic.

What have we learnt from biosimilar launches to-date?

After 15 years of biosimilars, significant progress has been made in savings and patient access for biologics that have lost exclusivity. With more biosimilar entries on the horizon, it’s important to reflect on some of the key learnings that have helped biosimilars succeed to-date.

Supply reliability is a must

Due to the complex nature of manufacturing biologics, it is not uncommon for shortages to occur. As such, supply reliability is a crucial factor when evaluating whether to use a particular biosimilar, as shortages can lead to delayed treatment and unplanned switching
Success is not a one-for-all market approach

Different countries have different policies and systems that affects how biosimilar uptake is supported. These can range from a number of factors such as the use of ‘winner takes all’ tenders, criteria for tenders, incentives for biosimilar use and promotion of educational materials. Such differences are observed even within the EU, where the uptake of biosimilars varies across countries. As an example, Norway has achieved a high uptake of biosimilars primarily via ‘winner takes all’ tenders based on price, whereas as the UK offers ‘multi-winner’ tenders with award criteria including additional services such as medicine training.

Originator companies are utilizing a variety of biosimilar defense strategies

As healthcare systems have adapted to the availability of biosimilars, so too have the companies that developed the originator biologics. Innovators like Roche are employing a long-view strategy to develop new biologics to eventually replace previous products. However, these companies are also employing several strategies to protect their market share as much as possible. Known strategies include offering heavy rebates with payers, improving the original product (e.g. excipient improvement), introducing subcutaneous formulations and providing dosing changes.
Another strategy of note is the use of patent thickets to prevent biosimilar manufacturers from entering the market, with the most prominent example being AbbVie for Humira. AbbVie has been particularly aggressive with its broad patent portfolio and legal strategy, even conceding its EU market to biosimilars in order to prolong its monopoly in the larger US market until 2023
Previously, most of the biologic opportunity came from a select number of high-value biologics. However, the number of products losing exclusivity will significantly increase in the next few years. Although most of these products will be smaller in value with smaller patient populations (e.g. Xolair for asthma/nasal polyps/urticaria), the two major LOEs to note are for the onco PD-1 inhibitors Keytuda and Opdivo. Despite LOE of both PD-1 products expected towards the late 2020s, several biosimilars are already at preclinical stage, with one manufacturer in China (Mabpharm) already initiating a Phase One trial.

In terms of therapeutic areas, the majority of the first wave biosimilars were for oncology and autoimmune indications. This is expected to change over the next 5 years, with an increasing number of biologic patents expiring in other therapeutic areas such as endocrinology (Prolia), ophthalmology (Eylea), and respiratory diseases (Xolair).