The Affordable Care Act created a fast-track for biosimilar FDA approvals, which allows manufacturers to get to market much faster than a typical drug. The speed of this process can create more of a surprise attack on existing in-market products in specific disease areas.
Biosimilar development is shaking up the pharmaceutical industry. These drugs are moving quickly through the pipelines in areas such as immunology, diabetes and oncology. For example, there are currently 11 biosimilars in the pipeline for Roche's breast cancer drug, Herceptin®.
Since biosimilars are positioned as a lower cost clone of an existing in-market product, payers are sprinting to develop guidelines for coverage. In addition, manufacturers are developing creative contracting strategies to reinforce their positions in their classes and defend against biosimilars. In contrast, other pharma organizations are finding ways to invest in biosimilars or even create visibility to their own development of these products.
Biosimilar Market Predictions
According to Deloitte, “Since the first biosimilar approval in the European Union (EU) in 2006, there are now more than 700 biosimilars approved (~450) or in the pipeline (~250) globally.”
Since many patients cannot afford treatment with high-priced biologics, there is a significant potential for the adoption lower-priced biosimilar drugs. The global market for biosimilar drugs is predicted to reach $17.9 billion by 2017, according to Global Industry Analysts, Inc.
Challenges to Expect
While the market for biosimilars is expected to continue growing, these products will encounter several challenges in the near-term future.
These challenges include:
- Regulatory uncertainty
- Complex production processes
- Competition with bio-betters
- Resistance from brand-conscious consumers
- Lack of clear regulations on interchangeability
Opportunities to Succeed
In order to overcome these development challenges, biosimilar manufacturers must ensure market access for their drugs.
“Biosimilars manufacturers will need to secure broad access to succeed in emerging markets. Manufacturers will need to work closely with policy makers and payers to implement reimbursement policies built on solid evidence,” according to Deloitte.
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