It is estimated that by 2025 biosimilars will reach a worldwide market value of over $61bn. In the last few years alone the European Union and United States have witnessed an increasing number of biosimilar applications and approvals. In 2017 the European Medicines Agency (EMA) approved 13 biosimilars for seven different originator products – thereby allowing greater competition for market use, driving down prices for first-in-line biologic treatments and furthermore potentially improving access to innovative second and third line therapies.
Biosimilar medicines are biological medical products that are an almost identical copy of an original product that is manufactured by a different company. Biological medicines are protein-based and are derived from living organisms. A biosimilar medicine can only be given approval once the ‘reference’ (or originator) medicine’s patent expires.
As of 2019, the NHS and other health systems across the globe have made significant strides in terms of adopting biosimilars and the cost-saving potential is widely recognised and implemented with organisations such as the National Institute for Health and Care Excellence (NICE). It is estimated the NHS by 2021 will be able to take advantage of over £300m in savings through the offering of various biosimilars.
Some commentators however have pointed out that there is still much to do. For instance in the EU5 (France, Germany, Italy, Spain and the U.K.) just 262 units of the biosimilar for AbbVie’s Humira (adalimumab) were prescribed since their launch in November 2018, compared to almost 21,000 units of the more expensive biologic – costing a total of €23.5m. The same number of units for the biosimilar would have cost €14.5m – meaning lost savings of nearly €10m.
Real-world savings have however been successful with particular drugs – for instance the NHS showed a cumulative cost saving of £38.8m over two years from the introduction of infliximab and etanercept biosimilars in the treatment of rheumatoid arthritis.
In the U.S. it is estimated by analysts that the biosimilar market will grow significantly and by 2024 will exceed $15bn. However between 2019 and 2023 there will likely be a lull in activity simply due to fewer losses of exclusivity in original biologic products. As it currently stands of the 16 biosimilars approved in the U.S. only three have actually been commercially launched.
Originator products such as AbbVie’s Humira, which lost its patent in November 2018 have already suffered market losses in Europe as international competition from biosimilars shaved 14.8% of total sales.
Production Efficiency and Education
The competition between biosimilar developers has accelerated and continues to do so as new entrants compete against each other to aggressively capture a significant market share. One example is Celltrion’s Remsima (infliximab) which on the back of superb marketing managed to achieve a 52% market share in Europe in the fourth quarter – marking the first time any biosimilars has surpassed the market share of the originator product. Additionally looking at Norway alone the health service saw an incredible 69% cost reduction with the use of infliximab biosimilar instead of originator reference Remicade, ultimately leaving the biosimilar with an 80% market share.
Currently biosimilars only account for 4% of the U.S. biologics market as compared to countries such as Japan and India which have seen penetration rates of 13% and 19% respectively. This is primarily due to a lack of education on the subject from doctors and payers who remain cautious in prescribing these new medications for use. This education deficiency is so glaring that the FDA’s Biosimilars Action Plan includes a promise to increase biosimilar education among health carers and the wider public. Just as generic drugs faced a similar symptom of slow initial uptake in the 1990s, so do biosimilars today and given the correlation between generics and biosimilars the primary indication is that the market is set to explode.
As the tables show, in the past two years alone, there have been more biosimilar approvals in Europe than in the 10 years from the first ever biosimilar approval back in 2006. Though expected lulls in activity will eventually pass, both Europe and the U.S. are set for significantly more biosimilar approvals in the coming years.
Additionally owing to cost-savings necessary for the survival of any biosimilar, or originator product, as well as prescriber familiarity, world-wide healthcare systems will not only have a greater choice of products on offer but also will be privy to truly astonishing potential savings that will enable greater patient access and what could be described as a ‘more personalised’ standard of care.