Biosimilars bill draws heat in Annapolis -- Gazette.Net


Life science and pharmaceutical representatives from throughout the country converged Wednesday in Annapolis to testify on a bill that would regulate how pharmacies could provide substitutes for biologics — the new wave of complex compounds developed by biotechs to treat diseases from arthritis to cancer.

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, which are derived from living proteins. Most conventional drugs are created without proteins and are more easily, and cheaply, replicated by generic drug-makers.

Likewise, generic versions of conventional drugs are more easily produced than biosimilar versions of biologics.

The bill had its hearing in the Senate Education, Health and Environmental Affairs Committee, which Conway chairs.

Representatives of several Maryland biotechs, including MedImmune in Gaithersburg, backed the bill during Wednesday’s hearing. MedImmune is the biologics division of AstraZeneca. Human Genome Sciences in Rockville, acquired last year by GlaxoSmithKline, also develops biologics.

The Tech Council of Maryland, represented by Brian Levine, described the bill as “pro-industry.”

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 that prescribing physicians be notified within five business days of the substitution.

The first biologic patent expires in 2014, paving the way for a biosimilar substitution, said Amy Dempster, senior manager of state government affairs for the mid-Atlantic region of biotech giant Genentech of South San Francisco. She said the industry is concerned about the ability to track the effects of biosimilars if multiple substitutions occur.

But Brynna Clark, director of state affairs for the Generic Pharmaceutical Association, said interchangeable biosimilars that would be approved for substitution face more rigorous federal vetting than other biosimilars and would probably not be ready as early as 2014, making the bill premature.

Some state organizations, including the Maryland Pharmacists Association, agreed, given that the FDA has yet to approve any biosimilars, 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 trade group. “This is too restrictive to be put into law.”

Schiff said last week that while regulations might be necessary when biosimilars first hit the market, any problems should sort themselves out within the first year.

Clark said the bill places “onerous burdens” on pharmacies, and biosimilars could save Marylanders as much as half of the $24.7 million that Medicaid spent on biologics in 2011 in the state.

She urged the committee to wait until the FDA develops its guidance before imposing what she called a “chilling effect” on biosimilar developers.

The precautions the bill focuses on might be addressed by this future guidance, said Jill McCormack of the National Association of Chain Drug Stores.

‘Good to have rules in place beforehand’

Others argued that the bill is not premature and that its provisions will protect patients.

“We believe whether a biological should be substituted should be decided by the physician and the patient,” said Allen Todd, a Silver Spring resident who uses biologics to manage his diabetes. Todd also is part of the Global Healthy Living Foundation, a New York nonprofit advocacy organization focusing on chronic illness.

Gene Ransom, CEO of the Maryland State Medical Society, or MedChi, said recently that the bill is not premature because biosimilars already are 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.”

This bill is “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 Tech Council of Maryland, 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 Conway’s bill has no negative fiscal effect and said it might be fiscally positive for the state by streamlining the process. A fiscal note attached to the bill indicates the measure would have minimal effect.

“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.

Legislative committees have approved biosimilar regulation bills in Virginia, North Dakota, Indiana and Florida, some with amendments. Mississippi has rejected a similar bill.