West Chester (July 25) – State Senator Andy Dinniman today announced that Senate Bill 514, legislation to allow for the use of biosimilars in prescription medicine, was recently signed into law as Act 95 of 2016.
Dinniman, who has been a consistent supporter and co-sponsor of the bill, said it will update pharmacy laws to give patients access to the information and prescription treatment they need to make knowledgeable and cost-effective health care decisions.
“Biosimilar medications show great promise in the treatment of chronic diseases like cancer, rheumatoid arthritis, diabetes, anemia, lupus and others,” Dinniman who serves as co-chair of the Senate Life Sciences and Biotechnology Caucus, said. “Like generics, biosimilars have the potential to make new and innovative prescription therapies available and accessible to a wide range of patients. The new law establishes guidelines to do just that in a safe, open, cost-effective and timely manner.”
Craig Tucker, Vice President of Policy and Public Affairs for Pennsylvania Bio, the Commonwealth’s trade association for the life sciences industry, also praised the move.
“We’re pleased to see Pennsylvania adopting policies that not only support a growing industry in our state, but more important, facilitate patient access to lower-cost, interchangeable therapies once approved as such by the FDA,” Tucker said. “This important bill will provide patients more opportunities to address their medical needs, particularly severely ill patients who rely on complex biological treatments.”
Patients suffering from chronic diseases and conditions can spend months or years trying to find prescription treatments that work for them. For some, effective relief comes in the form of biologics, a relatively new category of medications that are made from living cells. Biologics are far more complex than conventional or small molecule drugs. In fact, the structure of a biologic can be up to 1,000 times larger than a conventional medicine. Due to the complexity of the manufacturing process, they can also be much more expensive.
That’s where biosimilars come in. Unlike a generic drug, which is an exact copy, a biosimilar is a near replica of a biologic. Act 95 allows pharmacists to substitute a biosimilar for a brand-name drug, provided that the FDA deems the biosimilar “interchangeable” and the patient’s doctor is notified. Normally a substitution is allowed to be made by the pharmacist as long as it is not noted otherwise by the prescriber or patient, but since biosimilars are not a direct chemical copy of the original prescription, the new law was needed to provide further regulations of substitutions for these medications. Not only does this protect the consumer, but it also protects the pharmacist from liability as long as they stay in compliance with the law.
“This law represents a long journey we have taken to ensure that biosimilars are not only accessible to Pennsylvanians, but also pharmacists, doctors and patients communicate throughout the process,” Dinniman said.
Act 95 passed both the House and Senate by overwhelming majorities this summer. In approving the bill, Pennsylvania joined New Jersey, Delaware and at least a dozen other states that have similar laws in place.