A bill regulating when pharmacies could make substitutes for biologics and requiring patient and physician notice is drawing mixed reactions from the medical and biotechnology communities.
Senate Bill 781, introduced by Sen. Joan Carter Conway (D-Dist. 43) of Baltimore, is similar to one being considered in several states. It would regulate the dispensing of biosimilars, which are so-called “generic” versions of brand-name biologics — treatments derived from human or animal proteins. Most conventional drugs are created without proteins and are more easily, and cheaply, replicated by generic drug-makers.
Maryland biotechs such as MedImmune, a division of AstraZeneca, and Human Genome Sciences — acquired last year by GlaxoSmithKline — develop biologics.
The bill is set for a committee hearing at 1 p.m. Wednesday.
The proposal would allow pharmacies to dispense substitutes for biologics only if they have been approved by the Food and Drug Administration as interchangeable with the prescribed biologic and if the prescribing physician does not limit treatment to the biologic. The bill also would require that patients be notified in writing that the biosimilar is interchangeable and the prescribing physicians be notified within five business days of the substitution.
Some groups, including the Maryland Pharmacists Association, are calling the bills premature, given that the FDA has yet to approve any biologics, although the authority to establish an approval pathway was included in the federal Patient Protection and Affordable Care Act.
“I think when they do come out, they can be handled like generic drugs are handled today,” said Howard Schiff, executive director of the association. “This is too restrictive to be put into law.”
He said that while regulations might be necessary when biosimilars first hit the market, any problems should sort themselves out within the first year.
Schiff’s association has 1,300 members. He said most agree that Conway’s bill is premature. Schiff said he will testify at Wednesday’s hearing.
Gene Ransom, CEO of the Maryland State Medical Society, or MedChi, argued that the bill is not premature, because biosimilars are already used in Europe.
“It doesn’t take too much of a leap to realize this is happening soon,” Ransom said. “It’s always good to have rules in place beforehand.”
Ransom said his group supports the bill because members want to ensure treatments will not be switched without proper physician and patient notification. He said the proposed policy is consistent with what is included in pharmaceutical drug policies.
“It protects the patient. This is not like switching out a chemical; this is a living compound,” Ransom said. “This decision should not be made by some insurance company trying to save money by using a biosimilar.”
The Tech Council of Maryland also supports the bill. It’s “critical,” because it establishes guidelines for dispensing biosimilars instead of just having a patchwork of rules in 50 states, Douglas Doerfler, vice chairman of the trade group, said in an email to The Gazette. Doerfler also is CEO of MaxCyte, a Gaithersburg biotech that provides cell transfection systems.
“The complexity of biologics will invariably lead to some differences between the biosimilar and the innovator product and such differences could lead to clinical differences,” he said. “SB781 establishes criteria for safe substitutions and streamlining the substitution process, which is vitally important in reducing costs and creating a framework and pathway that will ensure patient safety.”
Doerfler also pointed out that Conway’s bill has no negative fiscal impact and said it might be fiscally positive for the state, by streamlining the process. As of Friday, the bill had no fiscal note detailing potential impacts.
“If a problem develops and the doctor does not know what product their patient is taking, there will be added costs,” Doerfler said, adding that the bill allows pharmacists time that works with their schedule to contact the prescribing physician.
Conway was not available for comment Friday.
Thus far, legislative committees have approved biosimilar regulation bills in Virginia, North Dakota, Indiana and Florida, some with amendments. Mississippi has rejected a similar bill.