ARLINGTON, Va. — Massachusetts Governor Deval Patrick on Tuesday enacted biosimilars legislation updating Massachusetts’s pharmacy law and paving the way for the substitution of biosimilars deemed "interchangeable" by the Food and Drug Administration. The governor took such action after passage of HB 3724 in both chambers of the General Court of the Commonwealth of Massachusetts.
“As a physician, I applaud the governor and the legislature for taking action to maintain the careful checks and balances needed in administering biologics,” said Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines. “Unlike chemical drugs, biologics are complex medicines treating complicated conditions. For that reason, regulations are needed to ensure doctors have a complete knowledge of what medicines are administered to their patients. I feel confident that this new law strikes the right balance in maintaining the safety and efficacy of biologic products, while advancing more treatment options to patients.”
Biosimilars, or copies that are similar to but not exact versions of the original biologic, are expected to be approved by the FDA as early as 2015.
While the FDA will deem whether a biologic drug is approved and "interchangeable," it is up to the states to decide whether one product may be substituted at the pharmacy level in place of the original biologic prescribed. This new law allows pharmacists to substitute a biosimilar for a brand biologic once the biosimilar is deemed to be "interchangeable." The pharmacists would be required to communicate that a substitution has occurred both to the patient, as well as the prescribing physician.
Physicians also would maintain the right to prohibit substitutions from occurring if the prescriber instructs otherwise in writing. The pharmacy will be required to maintain a record of each substitution for a period of at least a year.
Massachusetts is the third state this year to pass biosimilars legislation and pave the way for the substitution of biosimilars. “By ensuring that communication between physicians, pharmacists and patients remains a priority, we can monitor these complex therapies while providing the best quality and care,” Dolinar said.