13 Biosimilar Bills In State Houses

13 Biosimilar Bills In State Houses

February 8th, 2013 // 6:24 pm @ jmpickett

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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 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 (back story).

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 (read the two Mississippi bills here and here). The legislation was hatched even though the FDA has not yet approved a biosimilar yet 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 (AMGN), 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 (see more here).

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.”

We asked the Mississippi legislators – House representative Bobby Moak and state Senator Dean Kirby – for comment, but neither has yet responded. If they do, we will update you accordingly.

The legislative push, by the way, occurs as Amgen accelerates its own strategy for developing biosimilars. In a briefing with investors this week, the biotech disclosed that its targets include some of the biggest-selling biologics, including Roche’s multi-billion-dollar cancer drugs Avastin, Herceptin and Rituxan, as well as Eli Lilly’s Erbitux treatment. The Avastin and Herceptin patents expire in 2019, and the Erbitux and Rituxan patents expire in 2015, according to GrantThornton.

The announcement should not have been surprising, given that Amgen and Actavis – formerly Watson Pharmaceuticals – in late 2011 struck a deal to develop biosimilars, primarily in oncology. The first product, however, is not expected until between 2017 and 2019, by which time the FDA is expected to have established a development pathway. Versions of Amgen drugs are not part of the deal, although Actavis can do so outside the agreement (back story).

The simultaneous efforts to develop biosimlars while also pushing for legislation that restricts substitution may appear contradictory. “The company is clearly straddling two business opportunities that sometimes seem in conflict with each other – a defender of the innovative products and a participant in biosimilar products. That tension is going to continue to be difficult for them to manage,” Sanford Bernstein analyst Geoffrey Porges tells Reuters.

Just the same, Amgen continues to rely on its own medicines as a central revenue driver – the patent on its best-selling Enbrel treatment was recently extended to 2028 (read here). At the same time, access to biosimilars can differ in different countries, underscoring the notion that Amgen is looking well beyond the US to exploit copycats to generate sales. The emphasis on biosimilars, by the way, comes as Amgen attempts to lower costs, a move that includes cutting R&D