Biosimilars mean competition

Biosimilars mean competition, not marketing oblivion, for biologic brands

But biogenerics will be more like branded products than small-molecule generics, said Gil Bashe, who chaired CBI's 2010 Summit on Biosimilars and Follow-On Biologics last week in Washington, DC. “People look at biosimilars and assume we're looking at a world of generics, and we're not,” he said. Biosimilars will create two realms of competition—the innovator competing to make its product better and the biosimilar itself.

New biologic products are protected by 12 years of market exclusivity under the reform bill—far longer than the usual five years given to small-molecule players. After that, biosimilar competition should prompt innovators to maintain marketing, said Bashe, who is EVP and director of the health practice at PR firm Makovsky + Co.

“Traditionally when a small-molecule product goes generic, a company ceases to support it; that won't happen here,” he said. Competitive forces may drive innovators to invest in more clinical trials, exploring the possibility of new indications.

The model will be like branded to discounted-branded, rather than branded to generics,” noted Bashe, adding that only a few biopharma players will be able to afford to enter the space.

As for potential biogenerics targets, products with a very good history of safety will be considered. “The key hurdle to entering this marketplace is physician confidence and safety,” he said.

Bashe predicted that the US experience will be different, despite his belief that 1-4% market share will go to biosimilars in the first five years and 10-20% during the next five.

“This is not a question of erosion of the industry,” he said. “This is a question of transformation of a part of the industry...”

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