Asw. Lampitt: NJ Should Regulate Biosimilar Drugs

A bill working its way through the Legislature would have a significant impact on the state’s burgeoning biotechnology sector and pharmacists too. It would require pharmacists to notify doctors when they substitute a class of drugs known as biologics with substitutes called biosimilars. Biologics are cultivated from living cells. Biosimilars are similar to biologics, not identical but less expensive. Pharmacists are hoping the FDA will decide which are interchangeable. The biotech industry is fighting it. Sponsoring the bill to require more regulation is Assembly Deputy Speaker Pamela Lampitt. She told NJTV News Anchor Mary Alice Williams that the legislation would increase patient safety in New Jersey.

Lampitt says the substitutions need to be regulated because biologics and biosimilars are cultivated by live cells and the drugs attack the autoimmune systems of individuals using them.

“And during that sort of process a slight change in the development of a particular drug could cause a variation that could be extensively harmful to an individual,” said Lampitt. “So for example, they could have contact, sort of rash or even more severe they could have something that can exasperate an existing condition and maybe put you into a full blown asthma attack or something of that sort of nature.”

Lampitt said that there are biosimilars and the FDA is going to do an interchangeable biosimilar and that it’s going to determine when a biosimilar can be interchangeable to a biologic. Since there is going to be multiple interchangeables with different companies making them and because of the tenacious nature of the drug, Lampitt said it is going to be important for the prescriber — the physician — to know which drug is being issued.

When asked how biosimilars and biologics are different than substituting generic drugs for name brands, Lampitt said, “Well you know there are chemical-based drugs. They’re not as tenacious in terms of the acclimature within the body’s systems and as you said they are live cell drugs. And they do attack the body’s autoimmune system and so that’s why it’s so important and because the slight variation in the drug that’s being prescribed could have a different reaction to your chemical makeup, it’s so important that the actually prescriber know which drug has been issued because it’s the therapeutic care. These individuals are on these drugs — they’re cancer patients, they’re rheumatoid arthritis, they might have severe digestive problems. Their body is already compromised and being on a therapeutic level of a particular drug is essential to the success and the health of the individuals.”

On why it is important for the bill to pass in New Jersey, Lampitt said that if it doesn’t get passed, biosimilars and interchangeable biosimilars will not be able to be prescribed or distributed within the state.

“So patients’ safety, patient care and access with continuity of care is why we need to do it in New Jersey,” she said.