Biosimilars mean competition for biologic brands

Biosimilars/General | Posted 09/04/2010 post-comment0 Post your comment

The historic passage of two US healthcare reform bills on 21 March 2010, including a US Senate bill with an approval pathway for biosimilars, means biologic brands could see rivals replicate and market similar products, writes Mr Marc Iskowitz in Medical Marketing & Media. According to him, the new legislation, signed by US president Mr Barack Obama on 23 March 2010, lays out a series of requirements for the FDA to consider follow-on biologics (FOBs) applications.

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He reports that Mr Gil Bashe, Executive Vice President and Health Practice Director at PR firm Makovsky + Co, who chaired the Center for Business Intelligence (CBI)'s 4th Summit on Biosimilars and Follow-On Biologics held in Washington, DC, on 18-19 March 2010, said that biogenerics will be more like branded products than small-molecule generics. “People look at biosimilars and assume we're looking at a world of generics, and we're not.” According to him, 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 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 Mr Bashe.

“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.

Mr Marc Iskowitz points out that like the originator, biosimilars will involve a lot of infrastructure — regulatory, manufacturing, marketing and sales support. Advertising and medical education companies will need to help show physicians how these products are similar, but not bioequivalent to the original, a distinction that will take time to sink in.

As an example, he writes that when patents expire on brands like Merck's cholesterol pill Zocor, million-dollar advertising budgets usually fizzle as cheap generic competition takes over the market. Experts say the situation will be different once biologic brands face competition from FOBs in the US. However, far from sapping promotional dollars like small-molecule generics, biosimilars could spur marketing by makers of follow-on and original biologics alike.

“The model will be like branded to discounted-branded, rather than branded to generics”, noted Mr Bashe, adding that only a few biopharmaceutical 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.

The FDA has yet to flesh out an FOB approval process, including such details as whether new clinical trials will be needed.

Mr 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. He stressed that this is not a question of ‘erosion’ of the industry, but of ‘transformation’ of a ‘part’ of the industry.

Reference:

Marc Iskowitz. Biosimilars mean competition, not marketing oblivion, for biologic brands. Medical Marketing & Media. 2010 March 23.

Source: Medical Marketing & Media

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