On March 9th, a bill was introduced in the U.S. House of Representatives that would eliminate the requirement for a biosimilar to have the same strength as the originator product upon which it is based.
H.R. 7047, the “Lowering Costs by Improving Biosimilar Uptake Act”, would amend title III of the Public Health Service, permitting the Secretary of Health and Human Services to waive this approval requirements:
(I) The Secretary may determine, in the Secretary’s discretion, that an element described in clause (i)(I), or in clause (i)(IV) with respect to the strength of a biological product, is unnecessary in an application submitted under this subsection.
In addition to having the same benefits, potential side effects, and route of administration and the originator product- biosimilars are currently required to have the same dosage and strength as the reference product.
The bill has been referred to the U.S. House Energy and Commerce Committee. ASBM will continue to monitor its progress.