Pharma Effort to Protect Biologic Drugs Beyond Patents Runs Into Trouble
As more than a dozen state legislatures mull over bills that would make it more difficult to allow substitution of biosimilars, at least one effort appears to have gone nowhere. Despite identical bills that were introduced in the state Senate and House in Mississippi, the twin pieces of legislation failed to proceed to committee votes and, as a result, cannot be reintroduced in the current legislative session.
This apparently marks the first such defeat for a closely watched effort by such big biotechs as Genentech and Amgen (AMGN) to thwart rivals from having easy entre to their lucrative markets. Over the past few weeks, you may recall, legislators in several states have been introducing bills that would allow interchangeable biosimilar substitution, but only if more cumbersome conditions are met by prescribing physicians and pharmacies (covered in earlier Pharma news).
A key condition noted in the bills is that a biosimilar must have been deemed by the FDA to be interchangeable with the prescribed medicine for the specified indicated use. The legislation was hatched even though the FDA has not yet approved a biosimilar or decided whether a biosimilar is interchangeable with a brand-name biologic.
As we reported previously, there is debate about interchangeability. The Alliance for Safe Biologic Medicines, a group that includes Amgen, Genentech and the BIO trade group, wants clear lines drawn for substitution, such as giving physicians authority to specify “do not substitute” and that such an option should override any policy from payers or state law that would have substitution be the standard or default practice.
Conversely, the American Pharmacists Association, the National Association of Chain Drug Stores and the National Community Pharmacists Association support automatic substitution of interchangeable biosimilars and believe that if the FDA grants interchangeability pharmacists should be able to automatically substitute biosimilars under the provision of the Public Health Service Act.
“The push for these new measures has nothing to do with safety and everything to do with Amgen and Genentech, two biotech Goliaths, trying to thwart competition,” says Ralph Neas, ceo of the Generic Pharmaceutical Association, which also opposes the legislation. “With nearly $11 million spent in 2011 alone on costly biologic medicines in their state Medicaid program, Mississippi state legislators know that creating barriers between patients and newer, low-cost versions of these therapies is not right for their state.”
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Ed Silverman, a contributing editor of YCharts, is the founder and editor of Pharmalot. He previously reported on the pharmaceutical industry and other business topics for the Star-Ledger of New Jersey, New York Newsday and Investor’s Business Daily. He can be reached at firstname.lastname@example.org.
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