Patient advocacy or Amgen's blockbuster protection act? Biosimilars bills advance

Amgen has won a key victory in its coast-to-coast campaign to persuade state legislatures to require a pharmacist to notify doctors any time they substitute a biosimilar for a branded biologic.

The California Assembly has overwhelmingly endorsed the bill backed by Amgen ($AMGN), which is based in Thousand Oaks, CA. Now it's headed back to the state Senate, which has already passed a similar bill, where lawmakers will resolve any differences between the two groups before sending it on to Governor Jerry Brown.

The law is one of more than a dozen such bills which have been pushed in a variety of states as patient-protection legislation by the biotech giant and opposed as a blockbuster protection gambit by health plans and other big payers.

The payers' position, also backed by the Generic Pharmaceuticals Association (GPhA), is that Amgen and other big drug companies want to erect hurdles around prescribing biosimilars--less expensive knockoffs of branded therapies that lose patent protection. Any laws that require a pharmacist to report a switch, they say, will only hamper adoption of less expensive drugs--a process that has now become almost automatic in the small molecule side of the business.

While the FDA has yet to fully map out the regulatory pathway for biosimilar approvals, Europe has already approved several and big manufacturers like Sandoz--a division of Novartis ($NVS)--have a number of late-stage studies in development now aimed at toppling some of the biggest multibillion-dollar biologics franchises in the business. And that includes a few Amgen blockbusters in its aging pipeline.

Amgen lobbyists have been pushing hard to get the bills passed, saying that a complete record of which patients are getting a biosimilar will help ensure the safety of the country's drug supplies. If any drug recalls are ordered, they say, doctors will be able to instantly identify which patients received which treatments.

"This is a patient-focused bill that will increase access to biologic medicines in a way that facilitates a complete and accurate medical record and manufacturer accountability," Geoffrey Eich, executive director for regulatory affairs at Amgen, told members of the Assembly Appropriations Committee last week, according to a report in the Daily Journal.

Amgen also has a number of biosimilars of its own in development. Genentech has helped push for the new legislation in a number of states.

- here's the story from the Daily Journal
- read the report from Bloomberg

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