Biosimilars Could Save Billions Over the Next Decade

Biosimilars have been praised as a way to drive down the high costs of prescription drugs, especially those that treat specialty conditions. While biosimilars have already overcome significant hurdles, more work is needed to create a competitive market that could save billions of dollars, according to a report from Express Scripts.

Biosimilars provide an alternative to biologic drugs, which treat cancer, rare diseases, and inflammatory conditions. The uptake of these drugs is particularly promising because there are no meaningful differences between biosimilars and reference products.

Despite gaining regulatory approval, many manufacturers have faced issues getting their biosimilars to the market. This has led to a delay in biosimilar emergence in the United States compared with other countries that have successfully brought the drugs to market, according to the article.

Filgrastim-sndz (Zarxio) is an approved biosimilar to filgrastim (Neupogen) and is indicated to prevent infection during chemotherapy. The drug was launched in 2015 and costs 15% less than the reference product.

Infliximab-dyyb (Inflectra) is an approved biosimilar to infliximab (Remicade) and the biosimilar infliximab-abda (Renflexis), which has yet to launch. Infliximab-dyyb launched in November 2016 at a discount of 15%. These drugs are indicated to inflammatory autoimmune conditions, which are the most expensive drugs for payers, according to Express Scripts.

Additionally, a recent Supreme Court decision (Sandoz versus Amgen) would expedite the time from approval to launch, meaning that patients can benefit from cost-saving biosimilars sooner. The ruling allows manufacturers to market the biosimilar without the FDA’s decision on the approved indications.

Despite barriers, 16 manufacturers are aiming to develop biosimilars for 12 biologic drugs, with a combined market value of $38.5 billion, according to the report.

Express Scripts indicated that if a group of 11 biosimilars receive approval, it could result in $250 billion in savings over the next decade. More than $22 billion in savings would be caused by biosimilars for filgrastim and infliximab, according to the report.

The cost savings would also be seen by patients who pay lower co-payments and premiums for lower-cost biosimilars. Biosimilars would also be able to allow more patients to start therapy on a costly drug without an alternative, as less funds are being allocated elsewhere, Express Scripts stated.

Currently, pharmaceutical manufacturers may be engaging in practices that limit competition by biosimilars. These companies may be filing lawsuits, starting patient assistance programs to lower costs, and have started campaigns that question the safety and efficacy of biosimilars.

Biosimilars may also face challenges due to the debate on patent exclusivity for biologic drugs, according to the report.

To increase the emergence and uptake of the drugs, Express Scripts is developing solutions that lay the foundation for significant savings when the drugs launch. Thus far, the pharmacy benefit manager has started the Inflammatory Conditions Care Value Program to foster competition to etanercept (Enbrel) and adalimumab (Humira).

Express Scripts stated that payers can advocate for a speedier process for the approval and launch of biosimilars, while also benefiting from savings in the future, the article concluded.