Expanding Biosimilar Market May Drive Down the Cost of Treatment

This past week, advisory panels to the Food and Drug Administration gave unanimous recommendation for biosimilars of both Abbvie's Humira, and Amgen's Enbrel.1

Biosimilars are nearly identical copies of original biologic medications. The biologics Humira and Enbrel are used commonly in the treatment of conditions such as Rheumatoid Arthritis. Both Humira and Enbrel are two of the highest grossing drugs in the world, with combined sales nearing $23 billion dollars globally in 2015.2

Drug firm Amgen aims to produce the Humira copy, and Sandoz, the generic pharmaceutical division of Novartis, aims to produce the Enbrel copy.3

Though both drugs received recommendation, an FDA advisory panel is part of a preliminary process of approval. "The final decision will come from the FDA, and although it does not have to follow the advice of its panel, it typically does. The agency is slated to make a final decision by Sept. 25."4

It may be years before these drugs arrive on the market should they receive final approval. Currently "Amgen is suing Novartis’ generic and biosimilar unit Sandoz on the grounds that its biosimilar infringes several of Enbrel's patents."5 Abbvie's CEO Richard Gonzales says that the patent on Humira protects their market share until 2022, and that they intend to defend the patent from biosimilar manufacture.6

Slow progress aside, increased competition and cheaper treatment options should save money for consumers in the years to come. However, uncertainty exists as to how great those savings will be. The U.S. is just now entering the biosimilar marketplace, and the European Union has only had biosimilars since 2006. "Overall, in the European Union and other countries, biosimilars are priced at about a 25–30% discount relative to their reference products."7 The U.S. market will be different, with variations on policy, marketing, and insurance. Any prediction on cost differences between the original drug and the biosimilar is difficult at this time.

It seems likely that many insurance companies will require patients to use the less expensive biosimilars, just as they do with generics of other medications. Changing over to the cheaper products will likely be reflected in out of pocket costs.

Pending the probable outcome of FDA approval, the next decade will see a shift in the marketplace, with the biosimilars of Humira and Enbrel paving the way for RA treatments.


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