MUÑOZ COST SAVING BILL ALLOWING GENERIC BIOLOGICAL MEDS CONTINUES TO ADVANCE

Legislation to reduce the price of expensive biological medications for people who need the drugs for treatment of serious diseases by allowing pharmacists to substitute generics today won General Assembly approval. The bill, A-2477/S-1705, sponsored by Assembly Deputy Republican Leader Nancy F. Muñoz, now goes to the governor for his consideration.

Biological drugs (biologics) are 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.

“The cost of these drugs often places a financial burden on patients who rely on them to treat very serious diseases and painful conditions,” said Muñoz, R-Union, Morris and Somerset. “Generic versions are just now becoming available which is great news because they can significantly reduce costs, giving more patients access to these vital medications.

“At the same time, we need to make sure pharmacists and physicians are communicating with each other since these products are more complex than chemical drugs and it’s not yet certain what kind of a reaction a patient may have from a generic version,” she continued. “This bill enhances the safety and effectiveness of biologics while providing more treatment options to patients.”

Muñoz said measure 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 or generic for a biological drug.

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.