Reducing healthcare costs — or at least effectively managing increased costs — drives many innovations and strategies throughout the industry. In pharma, this goal is one trigger for the growth of biosimilars and biobetters.
The Growth of Biosimilars and Biobetters
Although the jury is still out on whether there will be a huge boom in biosimilars, some analysts still see great opportunity in their development because:
- Lower pricing for biosimilars and biobetters is expected to help address rising healthcare costs
- Patents for many high-value originator biologics will expire soon (between 2015 and the end of 2019, 39 biologics that represent $41 billion in U.S. sales and 30 percent of the total market lose market exclusivity)
- The U.S. Food and Drug Administration (FDA) has begun defining biosimilars regulatory pathways
Early on, some analysts cautiously predicted a $2-3 billion U.S. market for biosimilars by last year. Others have suggested that the U.S. biosimilar market will reach $8-10 billion by 2020. Some industry analysts estimate that the country could realize up to a $250 billion savings in pharmacy costs if multiple biosimilars reach the market in the next 10 years.
While many analysts are optimistic about the growth potential of the biosimilars market, they realistically acknowledge that growth will depend on the outcome of multiple challenges, including:
- How quickly the FDA issues final guidelines for biosimilars, and how difficult the approval process will be
- Whether payers and policy makers will see value in requiring or encouraging providers and patients to switch to lower-cost biosimilars
- How long it will take providers to accept biosimilars, especially for patients who are doing well on originator drugs
- Whether companies who have spent time and resources developing and marketing originator drugs attempt to slow the growth of biosimilars
- If pharma can make the required and time-consuming upgrades to biologics development and launch capabilities in key therapeutic areas
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