Biosimilars Action Plan: There's No Better Time Than Now

As the patents and exclusivity periods of blockbuster biologics are set to expire, biosimilar pharmaceuticals continue to emerge as a cost-effective, alternative treatment choice. With 3 new biosimilars approved by the FDA thus far in 2018, the biosimilar landscape in the United States is a hot topic of discussion.
There have been 12 FDA-approved biosimilars since 2015, but these approvals are accompanied by a host of legal challenges and opportunities that have limited the use of these drugs and increased competition among biosimilar manufacturers.
Pharma, payers, and the FDA are seeking to provide innovative strategies to contain costs while improving access to safe and effective treatments. Future market conditions suggest that specialty pharmaceuticals will drive future pharmacy costs.
The pipeline continues to be dominated by biotech, which are typically high ticket items that can receive a longer exclusivity period than other drugs. As a result, many payers are turning to biosimilars, which present a major opportunity for savings in health care costs and can potentially create headroom for new expensive drugs in the pipeline. It is estimated that the utilization of biosimilars could reduce direct spending by $54 billion between 2017 and 2026.
Although less than 2% of Americans use biologics, they represent 40% of total spending on prescription drugs, stated Scott Gottlieb, MD, commissioner of the FDA. To maintain a commitment to reducing health care costs, the FDA released the Biosimilars Action Plan on July 18, 2018. This plan aims to stimulate and improve the biosimilar marketplace in the United States, while mitigating competition within the industry.
What is a biosimilar?
A biosimilar is a complex biological product that is produced in a living system, which makes it more complicated to manufacture compared with a product that is chemically synthesized. The FDA specifically defines a biosimilar as a biological product that is highly similar to, and has no clinically meaningful differences from, an existing FDA-approved reference product.
Cutting edge technology is utilized to compare molecular characterization (ie, purity, chemical structure, bioactivity) between the proposed biosimilar and reference product. Although minor variances are acceptable, the FDA mandates that the proposed biosimilar is highly similar to the reference product.
Because there is some residual uncertainty that remains about how the biosimilar product performs in body, pharmacokinetic studies are employed so that a manufacturer can demonstrate that the proposed biosimilar has no clinical meaningful differences from the reference product in terms of safety and efficacy.

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