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Legislature Passes Biosimilars Bill

June 19, 2014

Biotech Caucus

The Senate today enacted legislation to allow pharmacists to substitute a biosimilar for a biological medicine when the United States Food and Drug Administration has determined that the two biological products are interchangeable and the prescriber has not instructed otherwise, Senator Karen Spilka, Chair of the Biotech Caucus announced.

“This important legislation will improve patient care and increase access to this new age of medicines in a safe, reliable way,” Senator Spilka said. “Massachusetts is at the forefront of medical innovation, and this bill will allow high risk, critically ill patients in our communities to safely benefit from biosimilars.”

Read more about biosimilars on MassBio’s website.

“This bill is taking a step in the right direction and will ensure the flexibility of our medical options for patients and doctors in Massachusetts,” Senate President Therese Murray (D-Plymouth) said. “The United States Food and Drug Administration has been establishing standards for licensure to ensure the safety and effectiveness of biosimilars and it’s important that we are proactive in addressing this issue.”

Following a substitution, the bill requires pharmacists to notify the prescribing practitioner and the patient.

Biological medicines are used to treat diseases and health conditions and are generally made from human or animal materials. They include a wide variety of products including vaccines and therapeutic proteins.

A biosimilar is a biological medicine that is highly similar to an already approved biological medicine that has no clinically meaningful differences in regards to safety, purity and potency.

The Public Health Service Act was amended in 2010 to create an abbreviated approval pathway for biological medicines that are biosimilar or interchangeable with an already approved biological medicine.

The bill ensures that patients in the Commonwealth will have access to biosimilar products once they are approved by the United States Food and Drug Administration.

The bill will now go to the Governor for his signature.

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