Massachusetts this week became the seventh state to allow for the substitution at the pharmacy of biosimilars deemed “interchangeable” with branded original drugs—legislation being enacted on a state-by-state basis.
The legislation is similar to what has been passed in other states and lays the groundwork for the dispensation of biosimilar medications—copies that are similar to but not exact versions of original biologics—which have yet to be introduced in the U.S. The first FDA approved biosimilars, which will cost less than the branded biologic drug, are not expected until next year.
Unlike generic drugs—exact versions of small-molecule, chemically-synthesized, brand-name pharmaceuticals that are FDA evaluated—biosimilars are manufactured from living cells and are similar to the original biologics but rarely are exactly the same. The FDA determines whether copies of biologic drugs are approved as interchangeable with the branded originals. Therapeutically equivalent drugs are those having the same active ingredient, strength of concentration, dosage form and route of administration but often using different cell lines and manufacturing processes.
However, policies to allow a biosimilar to be substituted in place of a doctor’s prescription for the original branded drug must be determined by each state’s legislature.
So far, seven states—Virginia, North Dakota, Utah, Delaware, Indiana, Florida and Massachusetts—have enacted laws covering biosimilars and interchangeable biologic medicines. They also include a requirement that pharmacists communicate to patients and their prescribing physicians that a substitution has occurred, and they give physicians the right to prohibit substitutions for branded biologic therapeutics. Another provision requires pharmacies to maintain a record of each interchangeable biologic substitution for a period of at least one year.
“This important legislation enjoys the support of physicians across the country, patient groups and both biologic and biosimilar manufacturing companies,” said Jim Greenwood, president of the Biotechnology Industry Organization (BIO) at its annual conference in San Diego this week. “By signing this bill into law, Governor [Deval] Patrick added Massachusetts to a growing list of states that have taken a leadership position in allowing retail pharmacies to substitute interchangeable biologic medicines.”
But not all states are in agreement. So far, 10 states have rejected proposed legislation. In California, Gov. Jerry Brown vetoed it last fall, stating that requiring pharmacists to send notifications about which drug was dispensed is both reasonable and controversial. He cited a warning from CalPERS, the state agency that manages pensions and health benefits for more than 1.6 million California public employees, retirees and their families, that the interchangeability requirement would cast doubt on the safety and desirability of more cost-effective alternatives to biologics.
Since the FDA has not determined which standards will be required for biosimilars to meet the higher threshold of interchangeability, Brown said in his veto statement, “to require physician notification at this point strikes me as premature.”
An editorial in TheLos Angeles Times agreed, saying drug safety is the FDA’s strength, the freedom to substitute is a federal law and generic drug equivalents have no similar requirements.
“If tracking substitutions is key to the safe use of biosimilars, such a requirement should be handed down from Washington,” the editorial stated. “State lawmakers should resist the urge to get out in front of the FDA in a way that could undermine the goal they’re purportedly trying to achieve.”
While other states are evaluating interchangeable biosimilar legislation, more than a dozen interchangeable biosimilars have been approved in Europe and have become widely popular.
“As a physician, I applaud the Governor of Massachusetts and the legislature for taking action to maintain the careful checks and balances needed in administering biologics,” Richard Dolinar, M.D., chairman of the Alliance for Safe Biologic Medicines, said in a statement at BIO. “I feel comfortable that this new law strikes the right balance in maintaining the safety and efficacy of biologic products, while advancing more treatment options to patients.”