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U.S. Brewing a Market More Receptive to Biosimilars


By Mari Serebrov
Washington Editor

The days of reading European tea leaves to predict the future for biosimilars in the U.S. may be coming to an end as the U.S. regulatory path for the follow-on biologics brews its own distinct flavor.

The biggest taste test will be market adoption. Although biosimilars have been available in the European Union (EU) since 2006, they have yet to become a general crowd favorite. The 14 biosimilar products approved by the European Medicines Agency to date have managed to capture only 12 percent of the market overall.

But slow market uptake of biosimilars in the EU doesn't portend the same for the U.S., Craig Wheeler, president and CEO of Momenta Pharmaceuticals Inc., told BioWorld Today. Unlike the EU, the U.S. has thrown interchangeability into the pot. "Interchangeability will be a big benefit," Wheeler said, as it will speed adoption and could lead to lower prices.

Because an interchangeable biosimilar is expected to produce the same clinical results as the reference drug in any given patient, it's more like a generic drug in that it can automatically be substituted at pharmacies in most states when a doctor prescribes the original biologic.

However, a copy that's merely deemed a biosimilar – which is highly similar to the reference drug but may contain minor differences in clinically inactive components – cannot be automatically substituted. Subsequently, makers of U.S. biosimilars that aren't interchangeable will have to invest in selling doctors and payers on their discounted version of a biologic in hopes of generating prescriptions. (Most EU member states don't allow automatic substitution.)

In the early days, biosimilars are expected to offer only a 20 percent to 30 percent discount over the reference product, many of which are well-known blockbuster biologics. Drugmakers could lower the price of the established drug, removing any incentive for prescribing a new-to-the-market biosimilar.

The future could be different for interchangeables. Because of automatic substitution, sponsors of interchangeables in the U.S. may be able to forgo much of that marketing effort, especially to physicians. Given the benefits, many companies developing biosimilars for the U.S. market are hoping to demonstrate interchangeability, even though the FDA has yet to issue guidance on how to do that.

When interchangeables hit the U.S. market, Wheeler expects a more aggressive uptake than what the EU has witnessed. The difference, he said, is that, in the U.S., market adoption will be driven by a community that's already used to substitution.

That's not to say biosimilars will have a warm greeting throughout the U.S. While Congress gave the FDA the authority to approve biosimilars and interchangeable biologics in 2010, whether – and how – automatic pharmacy substitution for interchangeables is allowed is up to state law. Because of the newness of the concept, some states are implementing safeguards to better track adverse events from substituted biosimilars. (See BioWorld Today, Jan. 29, 2013.)

Virginia was the first state to pass a law limiting pharmacy substitution and setting up notification procedures. The law permits substitution of interchangeables unless the prescriber or patient specifies no substitutions, and it requires pharmacists to inform patients of a substitution. (See BioWorld Today, March 22, 2013.)

To aid pharmacovigilance, Virginia requires pharmacists to record the brand or product name and the name of the manufacturer on the record of dispensing and the prescription label. Until July 1, 2015, pharmacists also must notify prescribers of a substitution and give patients retail cost information for both the prescribed biologic and the interchangeable biosimilar. North Dakota, Oregon and Utah have passed similar laws. But Arizona, Colorado, Florida, Illinois, Indiana, Maryland, Mississippi, Nevada, Texas and Washington rejected bills that would have made substitution burdensome for the pharmacy and physician. (See BioWorld Today, May 8, 2013.)

Similar legislation is still under consideration in California, Massachusetts, Oregon and Pennsylvania, and the Arkansas General Assembly has referred the measure to a study committee.

Regardless of burdens the states may impose, Wheeler said he thinks the future looks bright for interchangeable biosimilars in the U.S. The initial discounts won't be as steep as that seen with generic drugs because of the complexity of biologics and the cost of developing them, he said.

But in the very long term, as more bioimilars compete in the same space and scientific advances reduce manufacturing costs, he expects deeper discounts, possibly rivaling those of generics. "This will become a generics industry," he said.

Editor's note: For a copy of BioWorld's biosimilars report, please contact the BioWorld Data account managers for exclusive introductory pricing at (800) 477-6307.