AMCP: Clarity on guidelines stalls biosimilars’ debut


FDA is slowly implementing draft guidelines for bringing biosimilars to market, while states are enacting laws requiring additional notification and record keeping for the products

It has been four years since the U.S. biosimilar pathway opened up as part of the Affordable Care Act and two years since FDA issued its draft guidance reports on developing biosimilar products.  But thus far, no manufacturer has pushed a product through.

Lee Rosebush, a patent attorney with BakerHostetler; James Shehan, of counsel for Hyman, Phelps & McNamara; and Francis Palumbo, executive director and professor, University of Maryland School of Pharmacy, will speculate on the future of biosimilars in the U.S. marketplace in a panel discussion at Session 202 at AMCP today. Shehan says the FDA is moving at a glacial pace in implementing its draft guidelines for bringing biosimilars to market.

Most of the same issues that surfaced when the guidelines were created are still being debated.

“Many biosimilars, as biologics, will be dispensed by specialty pharmacies, and they will be confronted with a variety of issues related to formularies and coverage of any given drug order or prescription,” says Palumbo. “In many cases, their patients may be required to switch back from a biosimilar to the innovator product for therapeutic reasons because these biosimilars are not exactly the same as the brand name innovator biologics and differences may be more pronounced.”

Manufacturers are weighing the pros and cons of using the abbreviated pathway prescribed by the FDA for “highly similar” follow-on biologics, or biosimilars, against the higher clinical standards for introducing a therapeutically interchangeable drug that must contain the same active ingredients as the reference product.

In addition, there is debate surrounding whether biosimilars should be given the same International Proprietary Name (INN) as their brand name reference products. As of yet, nothing has been mandated. Manufacturers of the original products prefer using non-proprietary names, while generic companies want to keep the same standards for both reference and biosimilar products.

The panel also will discuss what the U.S. marketplace could potentially learn from Europe, where the first biosimilar was introduced in 2006.

Two other areas of interest, Shehan says, are state laws regulating biosimilars and the possibility of creating an “Orange Book” for biosimilars-much like the Approved Drug Products with Therapeutic Equivalence Evaluations book which can be found on the FDA website.

The presentation will also focus on how state trends and legislation associated with biosimilar substitution are likely to affect pharmacists/pharmacy practices. Panelists will discuss payer issues, such as coverage and formularies in the context of biosimilars.

Various states have taken positions on whether pharmacists will be permitted to substitute biosimilars for the original innovator drug. Some are enacting laws requiring additional notification and record keeping for the products.


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