Momenta Pharmaceuticals, Inc. (MNTA)

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Biotechs and Generic Drug Makers Compromise on Biosimilar Lobbying

http://blogs.wsj.com/pharmalot/2014/12/10/biotechs-and-generic-drug-makers-compromise-on-biosimilar-lobbying/?mod=yahoo_hs

By ED SILVERMAN

Two years ago, a coterie of biotechs began lobbying state legislatures to pass laws that would make it more difficult to substitute lower-cost biosimilars for brand-name biologic medicines. The plan was to require pharmacists to notify doctors when substituting one drug for the other, which would act as a deterrent by slowing the process. Generic drug makers responded with a counterattack.

The effort came as biotechs braced for the advent of biosimilars, which one analysis forecasts will save an estimated $44 billion in U.S. health care costs over the next decade. But the initiative stalled. A dozen states rebuffed the lobbying. A few states passed laws, but with provisions requiring renewal in two or three years. In the end, just one state, North Dakota, passed a law advocating what biotechs sought.

Now, the biotechs – led by Amgen AMGN -0.87% and Genentech – and their generic rivals have reached a compromise. Going forward, the companies have agreed to approach state legislatures with the same blueprint for substituting interchangeable biosimilars, specifically. This refers to a biosimilar that regulators say can produce the same effect in a patient as a brand-name biologic without any safety or effectiveness issues.

Although the FDA has yet to approve a biosimilar or decide whether a biosimilar might be interchangeable with a biologic, the legislative effort began because drug substitution is governed at the state level. And the maneuvering generated enormous attention, because the outcome held the potential to shape the extent to which lower-cost biosimilars would eventually become accessible.

“From our perspective, the legislative measures [proposed by the biotechs] would have restricted patient access to these new medicines,” says Ralph Neas, the chief executive of the Generic Pharmaceutical Association, an industry trade group. “We made the case that the original language in the legislation would erect barriers” for patients.

The compromise will allow pharmacies to automatically substitute medicines, but also require them to notify physicians and patients, and maintain an electronic record of the communications. This represents a shift from what was, until recently, all-or-nothing arguments the drug makers previously had over notification of a planned drug substitution.

For much of the past two years, the biotechs sought clear lines drawn for substitution, such as giving physicians authority to specify a substitution should not be made at the pharmacy. For their part, generic drug makers supported automatic substitution. The compromise closely mirrors a bill that was signed into law last June in Massachusetts, and language introduced in other states, which resulted from talks between the groups.

“The language adopted by the coalition has progressed by placing an appropriate emphasis on electronic technology to ensure accurate medical records, while creating a clear pathway for the substitution of interchangeable biological products,” an Amgen spokeswoman writes us. “We hope that this shared access will improve patient care and traceability of health outcomes for biologics subject to automatic substitution.”

A Genentech spokeswoman wrote us that “all states need updated laws in order to substitute biosimilars and we believe the compromise language will help towards the goal of getting the laws updated.” She adds the biotech will lobby alongside the generic association, which expects that effort to begin shortly and target two dozen or more states.

As an aside, the legislative push occurred as Amgen pursued its own strategy to develop biosimilars. The biotech has a development deal with Actavis, which sided with Amgen in lobbying state legislatures. An Actavis spokesman, however, denied this was factor. “We felt it was the right thing for patients,” he tells us. “It would enhance interaction between physicians and patients and ensure a higher level of care.”

“We are pleased to support this legislation, which we believe is consistent with the principles we have been advocating for throughout this process, including the establishment of a mechanism for communicating with physicians about which specific biosimilar product is used in patient treatment, enhancing the physician/patient partnership to ensure the highest level of care,” he adds in a note.