Are Biosimilars Too Expensive for Emerging Economies?

18-06-2012: The global market for biosimilar drugs is due to come under attack from popular generic drugs, as governments fight to control rising healthcare expenditure, according to healthcare experts GBI Research.

The report "Biosimilars in Emerging Economies - Advanced Recombinant Technology Platforms and Low Cost Manufacturing Put India and China at a Strategic Advantage in Biosimilar Production" states that governments in emerging economies are struggling to match the soaring demand for cheaper drugs, due to an increase in disease prevalence stemming from population growth, old age and unhealthy lifestyles.

However, the increasing awareness of biosimilars among physicians and patients could help biosimilars to gain significant market share, leading companies to consider offering reimbursements to patients for biosimilar products.

Clinical activities for biosimilars can take six to eight years — a time-consuming and costly process — and, while generic drug manufacturing can cost up to $5m, biosimilar development can cost as much as $80m–$120m. This is primarily due to the complex structure of biological drugs, which are difficult to manufacture, and the high number of patients required for trials to prove efficacy and safety.

The possibility of failure in the biosimilars development process is also significant, and even obtaining marketing authorization for biosimilars is an extensive and difficult process. As a result, only a small number of companies can afford to enter the biosimilars market.

Patients can save around 30% through buying biosimilars rather than the corresponding innovator products, but this is still comparatively more expensive than generic drugs, which can offer up to a 90% saving. Given that a biologic treatment for metastatic cancer can cost as much as $200,000 per year, even a substantial reduction in the cost of treatment with biosimilars will not match the value of generics. Most patients in emerging economies pay for medicine-related costs out-of-pocket, and affordability is therefore an issue for biosimilar manufacturers.

The biosimilars market in emerging economies was valued at $0.3 billion in 2002 and grew to a value of $3.3 billion in 2010 at a Compound Annual Growth Rate (CAGR) of 34%. It is forecast to grow further at a CAGR of 12% from 2010 to 2018, reaching $8 billion by 2018 at a CAGR of 12%.