Although the U.S. Food and Drug Administration (FDA) has not approved a biosimilar* or decided whether a biosimilar can be interchangeable, some of the states in world’s biggest market, are already considering bills that would allow substitution.
Biologicals are complex drugs, made in living cells and these group of drugs include some of the world’s best-selling drugs like Avastin, Herceptin, Mabthera, Enbrel, Remicade and Humira.
Last year, Illinois General Assembly introduced a bill to amend the state Pharmacy Practice Act to allow interchangeable biosimilar substitution, but only if certain conditions are met by prescribing physicians and pharmacies.
In the meantime, the Virginia recently introduced a similar bill that would allow a pharmacist to dispense a biosimilar that has been deemed interchangeable by the FDA. And in Pennsylvania, a state senator plans to introduce a bill. “The laws currently applicable to generics cannot be applied uniformly to biosimilar products… This legislation will create a new section pertaining to biosimilar products. Substitution will only be permitted if certain minimal thresholds are met including a decision by the FDA that the prescribed product and the biosimilar product are interchangeable,”.
And according to Pharmalot, in Texas, North Dakota and Indiana, similar legislation has already been proposed.
But the debate about interchangeability will not end soon it seems. Two innovator companies (Amgen and Roche/Genentech) are proposing bills that would restrict the ability of pharmacists to substitute biosimilars for originals, says the New York Times.
The paper states that, although biosimilars are on the market in Europe for several years, due to the regulatory uncertainty, these cheaper versions are unlikely to be available in the United States for at least two more years.
The Alliance for Safe Biologic Medicines (ASBM), that includes Genentech and Amgen, asks for clear lines drawn for substitution, such as giving physicians authority to specify “do not substitute” and that such an option should override any policy from payers or state law that would have substitution be the standard or default practice.
But, the American Pharmacists Association, the National Association of Chain Drug Stores and the National Community Pharmacists Association support automatic substitution of interchangeable biosimilars and believe that if the FDA grants interchangeability, pharmacists should be able to automatically substitute biosimilars under the provision of the Public Health Service Act.
At the end, the content of the debate is changing with years but it still didn’t come to an end in the US. We still have to wait more to see several biosimilars in the world’s biggest market.
*: FDA still didn’t approve a biological via biosimilar pathway.
Source: Pharmalot, New York Times