Biosimilars Market Analysis and Reports | USA Conference Series

Market Analysis - Biosimilars 2018

Biosimilars adoption in developed countries has been mostly payer-driven , based upon payers’ urgency and unmet need to contain public health care expenditures. In today’s emerging markets, biosimilars are still in a status that is nascent, with little to no marked presence. A recent Kantor Health Survey found that 20 percent of emerging market autoimmune patients use a biologic, with the distribution of biologics varying from 29 percent in China to 12 percent in Russia and a mere 6 percent in Brazil.

Biosimilars in USA:

  • USFDA approved the first biosimilar in March 2015 with Sandoz’s Zarxio (filgrastim)
  • Close to 19 pipeline biosimilar molecules are in development phase
  • Bisoimilars represent about 50% of the global biologics market value and generates about 50% of the sales value growth
  • Further approvals would be based on pending legislative decisions on data exclusivity period, naming conventions and interchangeability 

 

Biosimilars in European Union:

  • By far the largest biosimilar market representing 80% of global biosimilar spending
  • Nineteen biosimilar products authorized in four molecule classes: human growth hormone, erythropoietin, G-CSF and tumour necrosis factor (TNF)-inhibitor
  • About 29 pipeline biosimilars molecules in development
  • Most organized and unambiguous approval pathway
  • Pharmacy level substitution prominently into practice
  • Payer-driven uptake
  • Biosimilars are an integral part of the effective biological therapies available in the EU

Biosimilars in Asia:

  • Asia’s infrastructural availability can vouch for lower biosimilar development costs (e.g., US$11M–$20M in India and US$3M–$10M in China, versus US$100M–$250M in the U.S. and developed countries)
  • Asia countries will require Lower capital expenditure for GMP manufacturing facilities (US$250–$300M in the U.S.; 25–50% cheaper in Japan, India, South Korea and China)
  • Incur Lower labor costs in Asia (4%–73% of the cost of U.S. labor)
  • To date, China and India have approved 96 and 66 follow-on biologics respectively, while Japan and South Korea have approved 9 and 7 biosimilars, respectively
  • China has also provided generous funding, with US$308B allocated from 2010 to 2015 for biotechnology including biosimilars, and an additional US$11.8B earmarked for 2015-2020 to advance innovations in biotech.

 

Access to Biologic products
 
Regulatory Stringency
Payer's Perspectives
Prescriber's Perspective
Patient Acceptance
Available Biosimilars in market
USA
High
High
Low to Fair
Fair
Fair
0-5
European Union
High
Moderate to High
High
Moderate
Fair to High
>12
Japan High
Moderate to High
Moderate
Fair
Fair
~10
Mexico
Unequal/Fragmented 
Moderate to High
High
Low
Moderate
<5
Indonesia 
Low
Not Available
Moderate
Moderate
Low to Fair
<5  
South Korea
Unequal/Fragmented 
Moderate to High
High
Moderate
Low to Moderate
>10
Turkey
Unequal/Fragmented 
Moderate to High
Low
Moderate
Low to Moderate
~10
Brazil Low
Moderate to High
High
Moderate
Low to Moderate
<5
Russia
Unequal/Fragmented 
Moderate to High
Low
Low
Low to Moderate
<5
India Low
High
Low
Moderate
Low to Moderate
>12
China Low
Moderate to High
Moderate
Moderate
Low
~5
South Africa Low
High
High
High Moderate <5