Sen. Lee introduces Biosimilar Red Tape Elimination Act

Sen. Mike Lee (R-UT) introduced the Biosimilar Red Tape Elimination Act to increase competition within the biological drug market and reduce consumer costs.

For small-molecule drugs,  pharmacists can substitute generics in lieu of their branded counterparts. Access to generics is essential to increasing competition and bringing down the cost of prescription drugs for patients.  

The generic equivalent of a biological drug is known as a biosimilar. Unlike generic drugs, many states will not allow pharmacists to substitute a biosimilar unless the FDA declares it to be “interchangeable.” This process is cumbersome and expensive.

Acquiring interchangeable status requires the product to undergo switching studies whereby participants must alternate between the biologic and the biosimilar. These studies can cost millions of dollars and further delay market access. After examining 15 years of data, the European Medicines Agency (EMA) recently stated that switching studies are unnecessary for biosimilars to obtain interchangeable status. 

Sen. Lee’s bill would prohibit the FDA from requiring biosimilars to undergo switching studies to receive an “interchangeable” designation. Eliminating this barrier would increase access to lower-cost biosimilars and save payers and consumers billions over the next five years. 

Of the bill, Sen. Lee said, “Our regulatory environment is making it too difficult and expensive for biosimilars to make it to the market. Ultimately, it’s the patients who suffer from a lack of competition and high drug prices. My bill, the Biosimilar Red Tape Elimination Act, would bring down the barriers preventing consumers from accessing these life-changing drugs.

Of the bill, Professor Sarfaraz Niazi, who has extensively written and studied biosimilars, said, “I fully support the Biosimilar Red Tape Elimination Act introduced by Senator Lee to forbid the FDA from requiring additional switching and alternating studies in patients to allow interchangeability. According to the FDA, ‘biosimilars have no clinically meaningful difference with their reference product,’ so if there is no difference, they should be interchangeable without the extensive and expensive switching and alternating studies in patients. First, such studies can never fail, as statistics teaches us and as the hundreds of such studies reveal. These studies are tantamount to human abuse. Creating two classes of biosimilars has weakened the trust in biosimilars. The amendments suggested in the bill are based on scientific and ethical considerations, and it must be voted in by the Senate.”

Of the bill, Beau Sorensen, Chief Operating Officer of First Choice Home Health & Hospice in Utah, said, “With healthcare costs continuing to increase, we are grateful for Senator Lee’s leadership in helping patients get access to lower-cost biosimilar drugs by eliminating the red tape and unnecessary studies and steps that go into gaining FDA certification. This will be a huge help to our patients as they look to stay out of higher cost care settings through better access to affordable medications.

For full text of the bill, click HERE. 
For a one-pager of the bill, click HERE.