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What U.S. biosimilar "traditions" need to be broken in 2018?

Read the full article on Biosimilar Development here

Chris Isler and Magnus Franzen, life science experts at PA Consulting Group, are quoted in Anna Rose Welch’s article on the biosimilar industry and looking to 2018.

Chris and Magnus say that the costs of litigation and the impact these will have on developers are particularly concerning. Magnus outlined a scenario in which excessive delays from patent challenges ultimately impact a company’s margins and, in the end, the price at which the company is able to launch its biosimilar. Though companies are striving to define biosimilars by more than just price, the price tag is still integral in determining a product’s market share and the speed of uptake.

Magnus says: “Some executives we speak to are talking about a one-month window for reaching the market to put you on the right or wrong side of a successful business case for biosimilar development. Imagine the effect if a launch is delayed by three to six months or even years. This could have a domino effect where patent challenges delay market launch and increase the cost of market entry, in turn impacting the margins that a company can play with when setting a price.”

For some molecules, specifically Humira, Chris and Magnus argued the patent estate defense strategy raises questions about the current patenting system. “If the U.S. wants a healthy biosimilar market, it will have to address the current possibilities of protecting innovator drugs with multiple patents,” says Chris. “Though this is difficult for an individual company to address in the short-term, in the longer-term, biosimilar companies can continue to demonstrate the value biosimilars bring to society and patients by increasing access to affordable medication. By doing so, it will become increasingly difficult to say that the barriers of extensive patent estates are acceptable."

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