BURLINGTON, Mass., April 8, 2014 /PRNewswire/ -- Decision Resources Group finds that partnership activity in the biosimilar space increased 34 percent in 2013 compared with 2012. This increase was driven by biosimilar developers recognizing the need to augment their internal capabilities with those of an increasing number of market players looking to enter the biosimilar space. The high number of partnerships in place signals the complexity of bringing a biosimilar from the lab to the global market. The prize for success - a share of biosimilar sales estimated to exceed $19.5 billion in 2022 in the United States, Japan, Germany, France, the United Kingdom, Italy and Spain.
Other key findings from the Biosimilar Advisory Service: Corporate Strategies report:
- Innovator companies must adopt comprehensive defensive strategies to minimize sales losses from their multi-billion dollar franchises over the 2013 to 2022 forecast period.
- Multiple biosimilar manufacturers are employing novel clinical development strategies such as three-arm Phase I trials, including both U.S.-sourced and EU-sourced reference product, to de-risk and streamline later clinical development.
- Primary market research suggests that the positive endorsement of early adopter physicians will be instrumental in differentiating and driving the uptake of a specific biosimilar over competitor biosimilars of the same reference molecule.
- Legislation on the automatic substitution of biosimilars is continuing to evolve, with France reversing its previously held position and allowing limited pharmacy-level substitution.
Comments from Decision Resources Group Analyst Anees Malik:
- "We continue to see aggressive partnership activity in the biosimilar space, particularly from emerging market developers, highlighting an awareness of the breadth of capabilities required to bring a biosimilar to the global market and an indication of the increasing number of market players making a bet on biosimilars."
- "Both biosimilar developers and innovator companies have to determine the optimum strategies to pursue in an area which is highly dynamic and where the opinion of key stakeholders is still fluid."
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