FDA, FTC join forces to increase biosimilar availability

The Federal Trade Commission and FDA issued a joint statement outlining steps the two agencies plan to boost competition in the biologic drug market. 

Biologic drugs are made from living cells and treat many serious illnesses, including rare genetic disorders, autoimmune diseases and cancer. They're typically very expensive, and the U.S. spent $125.5 billion on biologics in 2018 alone. 

Biosimilar drugs are lower-cost versions of biologics created to bring down overall drug spending and are designed to have the same health outcomes. The first biosimilar was approved by the FDA in 2015 and since then, 26 biosimilars have received approval. 

Biosimilar drugmakers have argued that biologic drugmakers make it too difficult to compete in the market. They've accused biologic companies of spreading false information suggesting that biosimilars aren't as effective as biologics, deterring physicians from prescribing them. 

In response, the FDA and FTC said in their Feb. 3 statement that they will "take action" against false or misleading communications about biosimilars. 

Biosimilar makers have also argued that biologic makers refuse to give them samples of their drugs, which biosimilar makers need in order to complete testing to get regulatory approval. The agencies said they will "deter behavior" that blocks access to biologic samples. 

The FTC also said it will examine patent settlements to ensure biologic makers aren't making pay-for-delay deals, which is when a biologic maker pays a biosimilar maker to delay sales of its drugs. 

"Supporting a competitive marketplace for biologics, including biosimilar and interchangeable products, is essential for improving patient access to medicines and potentially reducing healthcare costs," the agencies wrote. 

Read the full statement here.

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