State biosimilars legislation hailed by GPhA

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WASHINGTON — The Generic Pharmaceutical Association (GPhA) and its recently formed Biosimilars Council have praised the enactment of new legislation in five states to allow automatic substitution for Food and Drug Administration-approved interchangeable biologic products.

Bills in Colorado (SB 71), Georgia (SB 51), Tennessee (SB 984), Utah (HB 279) and Washington (SB 5935) reflect core principles embraced in language agreed upon by GPhA and a wide coalition of brand manufacturers and other health care entities.

“GPhA and the Biosimilars Council commend Colorado, Georgia, Tennessee, Utah and Washington for passing laws that create a competitive market for biosimilar products and provide patient access to affordable versions of these critical medicines,” said Ralph Neas, president and chief executive officer of GPhA. “We are pleased these states have embraced a framework for these new medicines that reflects our organizations’ core principles: uphold the current pharmacy practice of automatic substitution; rely on the science-based determination of interchangeability by the Food and Drug Administration; and treat interchangeables and their corresponding brand biologics the same during dispensing at the pharmacy.”

The association notes that as biosimilars become available in this country states likely will pursue legislation that governs automatic substitution of biological products that the FDA deems interchangeable.

Since 2012, state substitution legislation has evolved significantly, and it continues to be introduced across the country. The GPhA position has not changed: The association strongly opposes legislation that includes mandatory prescriber notification requirements that could undermine confidence in the safety and effectiveness of biosimilars. Importantly, in the laws passed in these five states, communication would occur whether an originator biologic or an interchangeable biologic is dispensed, providing a level, competitive playing field for all of these medicines, said Neas.

“Notification, which GPhA opposes, is an alert before the medication is dispensed that a biosimilar or interchangeable biologic will be substituted for a brand biologic. Conversely, communication, a practice favored by GPhA and the broad coalition in support of last year’s compromise, takes place once the drug is dispensed and usually occurs automatically through electronic records, giving patients and providers comfort without altering existing pharmacy practice.

“The GPhA Biosimilars Council looks forward to working with state legislatures, supply chain participants, stakeholders, patients and others to expedite access to safe and effective biosimilar medicines,” said Neas.

The new bills call attention to how GPhA and such groups as the Biotechnology Industry Organization are working toward resolving long-standing differences on the issue.

For example, BIO president and chief executive officer Jim Greenwood said that the Senate bill in Washington state that Neas praised is in sync with BIO’s own principles on biologic substitution. “Senate Bill 5935 enjoys the support of physicians across the country, patient groups, and both innovator biologic and biosimilar manufacturing companies. This bill includes communication on all biologic medicines dispensed in order to maintain a consistent and complete medical record.”

“By signing this bill into law, Gov. [Jay] Inslee has added Washington to a growing list of states that allow retail pharmacies to substitute interchangeable biologic medicines.”

As announced in April, the Biosimilars Council “is designed to meet the unique needs of health care companies as they navigate this emerging space,” said Craig Wheeler, GPhA board chairman, and president and CEO of Momenta Pharmaceuticals Inc.

“In addition to being a voice with policy makers, this new division will be an invaluable partner for patients, providers, manufacturers, consumer groups and stakeholders from all corners of the supply chain seeking to stay apprised of critical developments regarding biosimilars,” Wheeler said. “The GPhA Biosimilars Council also will be a key resource for organizations seeking relationship-building opportunities, and a forum for in-depth scientific, regulatory, legislative and policy discussions.”

The council is the industry’s first educational resource for the general public and patient groups seeking information about the safety and effectiveness of biosimilars. Among its initial offerings is a new educational handbook that explains the benefits and science behind biosimilar medicines and who will benefit from access to these medicines and also outlines legal and regulatory frameworks.

“GPhA and its members historically have been the industry pioneers on biosimilars, beginning with their role as the fundamental organizing force behind the law which created the biosimilar pathway. The Biosimilars Council is the next evolution in this leadership, and will ensure these new medicines will deliver tremendous benefits for both our health and our health care system,” said Neas. “We look forward to continuing to work with our strategic partners and all stakeholders who share our vision of the transformative potential of biosimilars and interchangeable ­biologics.”


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