More than 700 follow-on biologic therapies are currently in development, and they are expected to account for around a quarter of the $100 billion-worth of sales stemming from off-patent biologic drugs by the end of this decade, according to new research.
It is rare to see a new business segment emerge in any market, but this is what is happening within the biopharmaceutical development industry, with 245 biopharma companies and institutes now developing or already marketing biosimilars throughout the world, says the study, from Thomson Reuters BioWorld.
Biosimilars promise to produce big savings, typically offering 20%-30% discounts on innovator biologics. The report expects them deliver savings of as much as $33 billion by 2020 across the European Union (EU) alone, even though uptake in the region is being held back by EU member states generally not permitting interchangeability.
In contrast, the US will permit interchangeability, and this is expected to speed uptake of biosimilars there, leading to lower prices, says the report. It also suggests that take-up of the recent World Health Organisation (WHO) proposal for a voluntary global naming scheme could level the playing field for biosimilars and their reference biologics.
In many parts of the world, biosimilars offer new hope to patients who previously have had no access to expensive biologic drugs, bringing their power for the first time of markets in Africa, Asia, Eastern Europe and Latin America.
And South Korea is a notable standout in the race for global industry leadership in this space, while India expects biosimilars to become the most important economic and therapeutic component of its already-robust biopharma industry.
The study also warns of a steep learning curve for both generics manufacturers, which currently lead the market, and the biologics firms, which hold the expertise. New pure-play biosimilar makers funded by governments and private investors also have a strong presence in this arena, and there are opportunities for smaller players - start-ups working to produce and sell biosimilars in emerging territories “could be the ‘David’ ticket to beat pharma ‘Goliaths’ that dominate those realms,” it says.
“Rather than forgo the benefits of biologics, governments and payers are counting on biosimilars to dramatically change drug development and patient costs by reducing the price tag of important biologics and increasing access to life-saving drugs. For this to happen, biosimilars must deliver the power of the reference drugs at a price developing countries can afford and gain the confidence of the marketplace – they have to create their own market,” says Jon Brett-Harris, managing director Thomson Reuters Life Sciences.