Although still a newer technology in the medical field, biosimilars remain an ongoing priority topic for U.S. Pain Foundation. The 2017 legislative session has seen 13 states take up the task of approving legislation pertaining to biosimilar products. U.S. Pain’s state advocacy team has been diligently tracking bills relating to this treatment option, with one bill bringing advocacy efforts all the way to the state of Alaska. But before turning the spotlight to Alaska, where pain ambassador-advocates testified on biosimilar legislation on Feb. 10, let’s first take a closer look at biologic and biosimilar products.
While both are produced by living cells for the prevention, treatment or cure of a disease, biosimilars are a type of biological product that is approved by the Federal Drug Administration (FDA) because it is highly similar to an already FDA-approved biological product. In other words, biosimilars are structurally similar to biologics. Unlike generic medicines which have an identical chemical makeup to their brand-name counterparts, biosimilars are complex substances and are sensitive to minor changes in the manufacturing process. Given its complexity, biosimilars have the potential to be less effective or cause more side effects compared with the original biologic.
To safely dispense this new wave of technology, U.S. Pain feels that substitution should occur only when the FDA has designated a biologic product as interchangeable. Only in this situation can patients and clinicians be assured that all reasonable efforts have been undertaken to assess possible adverse effects when one biologic product is substituted for another. U.S. Pain believes in the power of the patient and physician relationship. The prescribing doctor, as well as the patient, should be notified of a substitution.
This year’s round of biosimilar legislation being presented includes patient safety protocols such as communication to the prescriber by the pharmacist when a biosimilar medication is going to be dispensed. In Alaska, for example, Senate Bill 32 has been introduced on interchangeability of a biologic product and is supported by U.S. Pain and its volunteers.
The Senate Health & Social Services Committee held a hearing on SB 32, where it heard from pain ambassador-advocates Robert “Cajun Bob” Thoms and his wife, Cindy Caserta, on Feb. 10. Thoms, a U.S. Marine veteran who received six purple hearts and a silver star, shared his experience with treating chronic pain via teleconference. Diagnosed with rheumatoid arthritis five years ago, Thoms said he was fortunate enough to be prescribed a biologic medication. “I went from being bedridden to enjoying a functional life,” Thoms noted in his testimony. “I’m fully in support with U.S. Pain foundation on SB 32,” Thoms explained, going on to say that to have the option of having these biosimilars opens up a new day of hope for RA patients. “It gives those patients a choice. If my pharmacist and doctor agree that I should try a biosimilar I would do it tomorrow, I would literally do it tomorrow.”
Caserta also shared what it’s like to look after husband, despite having chronic pain herself. “This bill affects me directly as a caregiver,” Caserta said, while expanding on her husband’s negative experience with a medication that was not a biologic. “After Bob got on the biologic, he showed remarkable improvement.” Caserta said she and Thoms are cautious, however, when it comes to depending on just one treatment option to continue managing his chronic pain. “If the FDA approves more biosimilars and other meds we’ve been talking about today, Bob and other Alaskan residents can benefit by having options. If Senate Bill 32 is passed, patients can make informed choices about other perhaps cheaper biologics and then his doctor and others will be notified within days and together, they can monitor its effects.”
Following testimony, the bill was referred to the Labor and Commerce Committee, proving once again that sharing personal stories from pain warriors and their family members makes a positive difference when supporting or opposing bills which impact the chronic pain community.
To listen to their testimony, visit this link. Their testimony begins at 58:00.
“We are so thankful to Bob and Cindy for their dedication to Alaskan residents who deserve access to treatment options that effectively manage their health conditions,” says Shaina Smith, director of state advocacy and alliance development.
Smith notes that in addition to the forward progress of the bill in Alaska, on Feb. 22, Montana passed House Bill 233, regarding biosimilars, into law. “U.S. Pain is thrilled that Governor Steve Bullock signed this important bill. Now, in addition to Alaska, we’re turning our focus to 11 other states that currently have biosimilars bills in process.”
Current Biosimilar Legislation Across the Country:
Alabama HB 82—Under existing law, the state’s Board of Pharmacy regulates the manner in which a licensed pharmacist may dispense a different drug or brand of drug than that ordered or prescribed without the express permission of the prescriber. This bill would allow licensed pharmacists to dispense a substitute biological product for certain biological products that have been interchangeable or therapeutically equivalent by the FDA. A hearing date has not been set by the Committee on Health.
Arkansas HB 1204/SSB 1029—This bill would allow pharmacists to make biological substitutions. It was referred to the House Public Health, Welfare and Labor Committee. HSB 38 relates to the prescribing of biological products and makes penalties applicable. In early February it passed the subcommittee and is now waiting on further action to be taken.
Iowa SSB 1029—this is the companion bill to HSB 38 and was heard before a meeting of the subcommittee of the Senate Human Resources Committee. A hearing date has not been scheduled yet.
Kansas HB 2107—This legislation concerns public health, relates to the pharmacy act of the state of Kansas and pertains to biological products. The Houesd Committee of the Whole elected it be passed as emended. The final action resulted in 114 yea votes and 10 nay votes.
Maryland SB 997—Authorizes a pharmacist to substitute an interchangeable biological product under certain circumstances and to inform specified consumers of the availability of an interchangeable biological product and the approximate cost difference as compared to a specific drug. The State Board of Pharmacy would also be required to maintain on its website a link to a specified list of biological products. On March 9th there will be a public hearing within the Senate Committee on Education, Health and Environmental Affairs where SB 997 will be read; advocates are encouraged to testify on behalf of this legislation.
Minnesota HF 712—Substitution standards for biological products are established within this bill, which also modifies and adds definitions. It has been referred to the Health and Human Services Reform Committee.
Nebraska LB 481—This bill would provide for drug product selection for interchangeable biological products. There was a hearing in the Health and Human Services Committee and has been placed on General File (the first stage when a bill is considered by the full Legislature).
New Mexico HB 260/SB 180—An act to amend the NM Drug, Device and Cosmetic Act to provide for regulation of biosimilar products. This bill passed the house unanimously and is awaiting further action. SB 180, the companion bill to HB 260, was placed on a hearing before the Senate Public Affairs Committee. A committee report was adopted-Committee substitute/DO PASS committee report adopted; floor amendment adopted-passed Senate 39-0. It was moved to the House Business & Industry Committee/House Judiciary Committee-House Business & Industry Committee.
South Carolina HB 3438/SB 299—A bill to amend section 39-24-20, code of laws of South Carolina, 1976, relating to definitions in the drug product section act, so as to change the definition of substitute to include interchangeable biological products. The committee reported it favorable with amendment and is awaiting a hearing date. SB 299, the companion bill to HB 3438, is still awaiting a hearing date after being referred to the Committee on Medical Affairs.
Vermont has a bill with its name to be determined; it was heard by the Senate Health and Welfare Committee on Feb. 21.
Wyoming SF 0121—An act relating to the Wyoming Pharmacy Act; modifying grounds for suspension and revocation of pharmacy licenses; modifying responsibilities of the pharmacy; modifying provisions related to examination and reexamination and other provisions. It was referred to the Joint Corporations, Elections & Political Subdivisions Committee and is awaiting a hearing date.
To get involved in biosimilars advocacy, contact firstname.lastname@example.org.