Signing Paper

Massachusetts Enacts Biosimilar Substitution Law

July 1, 2014

Massachusetts has become the eighth state to pass a law enabling pharmacists to substitute a biosimilar for a branded biological product, earning praise from industry groups that believe such state laws are vital to biosimilar adoption.

The law, signed by Massachusetts Gov. Deval Patrick (D), enables pharmacists to fill a prescription using a biosimilar instead of a biological product. The biosimilar must be cleared by the FDA to be interchangeable with the prescribed product, according to the law.

Pharmacists also have the responsibility to notify the physician and patient of the substitution. In addition, a pharmacist cannot substitute a biosimilar if the physician explicitly requests otherwise, the law says.

The state substitution laws come as FDA continues to develop a regulatory pathway for determining whether a biosimilar is interchangeable with a biologic.

States play a major role in crafting policies on how a product can be substituted in place of a doctor’s prescription, the Biotechnology Industry Organization said. The law in Massachusetts “maintains incentives for innovation and promotes a competitive market for biologic therapies,” BIO noted.

The Generic Pharmaceutical Association also praised Massachusetts’ action, adding that it supports legislation that does not add burdens to current pharmacy practice.

Massachusetts was the second state to adopt biosimilar legislation in June. Delaware passed a law that includes some liability protections for pharmacists, and requires them to notify doctors when a substitution is made. The two states join Florida, North Dakota, Utah, Indiana, Oregon and Virginia to adopt biosimilar substitution laws.

While the agency continues to develop the approval pathway, it is releasing guidance to help manufacturers prepare for biosimilar submissions. Recent draft guidance details the relevant pharmacokinetic and pharmacodynamics data drugmakers need to use in clinical trials for determining biosimilarity to a biologic. The guidance is one of five that the agency plans to release this year on biosimilars. — Robert King

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.