Times, they are a-changin’—at least for the American biological product market.
With five major biological products worth a collective US$35 billion in annual sales now facing imminent patent expiration, the market is poised to develop and commericialise biosimilars. With the new abbreviated regulatory pathway now in place in the US, the race is on to develop strategies that will ensure the rapid acceptance of biosimilars.
And some of those approaches will come directly from the European experience. While their lessons have been slow in coming, the EU is ahead of the US in market development and currently leads the world in biosimilar sales. Although the European experience differs markedly from the anticipated evolution of biosimilars in the US, there are lessons to be learned.
In Commercialisation of Biosimilars: strategies for market penetration, FirstWord expertly examines the European experience and what it means for other developed markets. Based on expert opinions from the top commentators in the field, the report offers insight into how European biosimilar markets have evolved, includes up to the minute US case studies and which strategies have proven effective—and why.
Key Report Features of Commercialisation of Biosimilars: strategies for market penetration include:
The biosimilar market in the US is poised to take advantage of major biologicals going off patent. Through Commercialisation of Biosimilars: strategies for market penetration, you will:
Commercialisation of Biosimilars: strategies for market penetration answers key questions:
“When it comes to long term treatments I think that doctors are more reluctant to use biosimilars because immunogenicity concerns have been highlighted by the biotechnology industry. They want to see more evidence on their long term safety.” Steinar Madsen, Medical Director, Norwegian Medicines Agency, Norway
“In a market like the US, you really will need these dual strategies where you need to have a pretty well thought out market access strategy, working with payers, while the sales and marketing tactics, will look a little bit different from what we're used to with traditional innovative products. It's not differentiating on the product profile but it's really establishing biosimilarity.” Sophie Opdyke, VP Commercial Development, Pfizer Biosimilars
“For a biosimilar to come in there and think they're only going to compete on price, I think it's going to be a challenge for them, to say the least. I think we got too used to the analogy of how generics work in the US now and we forget all the early days. It takes a lot of trust building in these early years (of product safety and efficacy), to get people to an understanding to use such products. That's important.” Virginia Acha, Director Regulatory Affairs, Amgen, UK
As the nascent US biosimilars industry prepares to commercialise, lessons can be learned from the European experience. In this report, you will discover:
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