Cost saving legislation Assembly Deputy Republican Leader Nancy F. Muñoz sponsors that will allow pharmacists to substitute biosimilar (generic) forms of biological medications won approval today from the Assembly Health and Senior Services Committee.
Biological products (biologics) are medications created from living cells (animal, yeast, plant) rather than through traditional chemistry, which produces chemical pills. They are used to treat cancer, rheumatoid arthritis, diabetes, MS and other debilitating diseases. While a (chemical) generic medication is identical to a brand named drug, replication of an identical biologic by another manufacturer is nearly impossible.
“Biologics are used to treat very serious diseases and painful conditions, but for many patients they are unaffordable.” said Muñoz, R-Union, Morris and Somerset. “Generic versions can significantly reduce costs, giving more patients access to these vital medications.”
“Since these products are more complex than chemical drugs you never know what kind of a reaction a patient may have. That’s why communication between pharmacists and physicians is so important,” she continued. “This bill enhances the safety and effectiveness of biologics while providing more treatment options to patients.”
Muñoz said the legislation, A-2477, is needed to ensure that once the FDA has approved a biosimilar as “interchangeable” with a biologic, a law is in place to address the issue of substitution. Currently, the only biosimilar product approved by the FDA in the U.S. is Zarxio. Manufactured by Sandoz, it is the generic version of Neupogen, made by Amgen, Inc. It is used to treat patients with certain types of cancers and related illnesses, but has not yet been approved as an “interchangeable” product. “Interchangeable” means that pharmacists may substitute a biosimilar for a biologic.
Under the bill, a pharmacist who dispenses an interchangeable biosimilar is required to notify the prescribing physician of the substitution within five business days after dispensing the medications and provide the name and manufacturer of the product.
Muñoz noted that only Virginia, Indiana, North Dakota, Delaware, Florida, Utah, Oregon and Massachusetts have passed similar legislation. Should the measure become law and, as more biosimilars become available, New Jersey would be at the forefront of providing cost effective medications for patients with debilitating diseases. She added that both generic and brand manufacturers support the bill.