The Assembly yesterday passed a bill regulating how biosimilar medications are dispensed -- in advance of biosimilars themselves. The new type of biologic drug is not currently sold, marketed or approved for the U.S. market. That's one of the problems cited by opponents of the bill.
"Certainly the advent of biosimilars offers the promise of substantially lower cost … but the FDA has not approved a single biosimilar or developed any protocol for their use," said Assembly member Bonnie Lowenthal (D-Long Beach). "This bill creates an unnecessary roadblock that will inhibit access to an important medication."
But that argument didn't hold water with several members of the Assembly yesterday.
"The argument made on the floor is that we should wait for the federal government to issue its regulations on this," said Assembly member Scott Wilk (R-Santa Clarita).
"Since when has this body ever waited on the federal government?" Wilk said. "This bill facilitates biosimilars, and we're going to be ready when biosimilars come on the market."
The fact that legislators now are speaking knowledgably about biosimilars is a pretty big accomplishment in its own right, since no one in Sacramento knew what a biosimilar was earlier this year when Sen. Jerry Hill (D-San Mateo) first introduced SB 598.
Biosimilars are basically copies -- or generic versions -- of biologics, which are a type of pharmaceutical treatment different from chemically synthesized drugs. Biologics are created by biologic processes.
Assembly member Richard Pan (D-Sacramento), chair of the Assembly Committee on Health and a practicing pediatrician, introduced the bill on the Assembly floor yesterday.
"This bill will save the state and consumers money by allowing substitutions by pharmacists," Pan said, adding that the bill's requirement for a pharmacist to notify a prescribing doctor of changes is particularly important.
"As a physician, I know biologics are complex proteins, so it's helpful to be able to track over time what a patient received, so we can track adverse reactions," Pan said. "There is no question this will reduce costs and protect consumers."
The bill passed its Assembly floor vote yesterday just five days after clearing its last Assembly committee. It already passed the Senate, and needs to return there for concurrence before heading to the governor's desk for approval.
"We're not done with this issue," said Brynna Clark, senior director for state affairs at the Generic Pharmaceutical Association. "It still has to go back to the Senate and to the governor's desk. There is no reason to go above and beyond the FDA and force something like this through. We're disappointed, but we're not done."
Opponents of the bill recently were joined by a powerful ally, when CalPERS, the state employees' retirement system, voted to oppose the bill.
"There are reasons we have an FDA," Clark said. "There are reasons why they should make the determination on certain issues."
To Eve Bukowski, there is no time like the present to facilitate lower-cost biologics. Bukowski is a cancer patient who uses biologic medication every three weeks, and said any bill that might increase access to the new therapy is good legislation.
"We are delighted with the vote, it was a strong vote to make sure patients get access to lower-cost biologics," Bukowski said. "They say that the quickest way to bankruptcy is to get cancer, so this is something I just don't think we can pass up."
That's a message she hopes to convey to the governor.
"Without this bill, pharmacists can't make these substitutions," Bukowski said. "We want to make sure the governor understands the critical nature of this bill. We want to make sure he hears that message."