Since 2015, the healthcare industry has been tracking the progress and awaiting the wide-scale availability of biosimilars, a potentially more affordable alternative to biologic products. But the slow proliferation of these products continues to be the difficulty in getting them to market and navigating the many twists and turns of the regulatory and reimbursement process. These issues were discussed in a recent Drug Store News article.
The DSN article notes that, despite projections of billions of dollars in potential savings from biosimilar drugs as biologics lose patent protections, the hurdles these drugs have to overcome to make it to market delay release, eat into potential profits, and keep patients from having access to treatments that may be priced 10-15% lower than their reference drugs.
Largely the obstacles these products face are legal, as biosimilars have to prove they are not violating the intellectual property rights of their reference products in order to secure approval. Litigation from the manufacturer of the reference product has impacted FDA approval and timing of release in several cases so far.
Other issues that complicate the approval of biosimilars include:
- Naming conventions
- Interchangeability of biosimilars with their reference products
- Inconsistent payment rates for reimbursement
The article quoted a RAND report: “We must put the patient at the center of the FDA’s guidance for naming and interchangeability to reduce confusion and unreasonable requirements that ultimately impact patient access.”