States beg to differ on biosimilar concerns

ANNAPOLIS, Md.—Known as the Old Line State, Maryland hasbecome the fourth state to reject legislation that aims to restrictpharmacists' ability to substitute cheaper biosimilars for their referencebiological drugs. The legislators' final vote on April 8 fell in line with theGeneric Pharmaceutical Association's (GPhA) stated opinion that such a law"would create red tape between patients and affordable medicines."

The failed Maryland legislation also would have required pharmaciststo give specified notices and record specific information if a pharmacistsubstituted an interchangeable biosimilar biological product for a prescribedbiological reference product.

"We applaud the Maryland state legislature for making this wisedecision," said Ralph G. Neas, GPhA's president and CEO, in an April 10statement. "Maryland legislators know that passing laws requiring unnecessarynotification and recordkeeping would create 'red tape' between patients andaffordable medicines. We agree with the Maryland Department of Health andMental Hygiene, which, in opposing this legislation, called it 'premature andunnecessary' at this time."

At issue in the defeated Maryland bill, and in other statesas well, is whether to include requirements for physicians and pharmacists onbiological substitution. The Patient Protection and Affordable Care Act of2010, the healthcare reform package signed into law by President Barack Obama,authorized a regulatory pathway for biosimilars. In February 2012, the U.S.Food and Drug Administration (FDA) issued three draft guidances relating tobiosimilars. The FDA is expected to release its final guidelines soon.

The approval pathway, as established by federal law,distinguishes between biologic products that are "biosimilar" to an innovatorbiologic, meaning they are "highly similar" to an innovator product, andbiologic products that meet a heightened standard to be deemed"interchangeable."

While generic drugmakers, pharmacists and pharmacy benefitmanagers defend and support automatic substitution of biosimilars legislation,it is the FDA which appears to hold all the cards in the center of one of themost controversial legislative issues in years. That's because several statesare taking a wait-and-see attitude before bringing biosimilar legislation to afloor vote.

Although the FDA's role in the approval of biologic andbiosimilar medicines includes the designation of an interchangeable status, thepolicy on whether one biologic product may be substituted by dispensers when adifferent biologic product is prescribed is governed by state law—and gettingthe states' legislators to agree with the legislation is the crux of the matterfor drug companies in light of the 2016 so-called "patent cliff" for many brandedbiologic therapies.

While appearing neutral, FDA Commissioner Margaret Hamburgmay have tipped her hand. She recently stated that attempts to undermine trustin biosimilars appear to be "worrisomeand represent a disservice to patients who could benefit from these lower costtreatments."

Three other states—Arizona, Mississippi and Washington—havealso rejected similar legislation, while Arkansas concluded that the biosimilarissue warranted further research and sent its legislation back to a committeefor further study.

Although Maryland did not move forward legislation thatwould have included such provisions, other states have passed such legislationor are considering it. In late March, North Dakota signed into law requirementsrelated to the interchangeability of biological medicines, while Virginia andUtah passed such legislation—but attached were sunset provisions for when themeasures would expire.

Nine other states are considering legislation: California,Colorado, Illinois, Indiana, Florida, Massachusetts, Oregon, Pennsylvania andTexas, according to GPhA.

In January, the Biotechnology Industry Organization (BIO)issued its "five principles on biologic substitution," a framework ofrecommendations for states to follow in adopting policy on biologicalsubstitution. The BIO principles call for substitution only when the FDA hasdesignated a biologic product as interchangeable, authorizes prescribingphysicians to prevent substitution, requires both the prescribing physician andpatient to be notified of substitution and requires the pharmacist and thephysician to keep records of the substitution.