A new regulatory pathway has paved the way for the introduction of increasingly complex biosimilars in the United States, which has generated a great deal of excitement among pharmaceutical contract manufacturing organizations (CMOs) about possible new business opportunities.
In a new report from PharmSource, Catching a Wave: How Much Will CMOs Benefit from Biosimilars?, experts warn that such excitement is unwarranted and conclude that if CMOs hope to attract biosimilar business, they must provide meaningful value beyond mere manufacturing capacity.
Biosimilars are animal and human products that are “highly similar” to approved and licensed products that include vaccines, blood components and proteins. Biosimilars must have no clinically significant differences in terms of safety, purity or potency; differences are due to clinically inactive components.
Making extensive use of data, PharmSource researchers conducted an analysis of both commercialized biosimilars and biosimilars currently in development in the United States and Europe. The report assesses the degree to which CMOs that manufacture drug-substance or drug-product might benefit from the biosimilar boom.
The short answer to that question is not much, said Jim Miller, president of PharmSource and co-author of the report. PharmSource researchers found that financing and in-sourcing present significant challenges to CMOs seeking to move into the biosimilar space. CMOs that want to land biosimilar business must offer benefits or value beyond mere manufacturing capacity, he said.
“Biosimilars are not an especially big opportunity for CMOs because of the competitive dynamics of the end market for biosimilar products,” he said. “The challenge for CMOs today is to develop a strategy that enables them to participate more meaningfully when a third wave of biosimilar opportunities begin in 2020.”
The report includes data useful to CMOs and bio/pharmaceutical companies looking strategically at the outsourcing of drug manufacturing.
PharmSource (pharmsource.com) is the recognized unbiased authority of knowledge about the global bio/pharmaceutical contract services industry. The company’s proprietary publications, databases, research tools and analyses inform buyers and sellers of bio/pharma contract services about industry trends, activities and partnership opportunities.
Since 1996, CMOs, CDMOs and CROs worldwide have looked to PharmSource for critical information delivered with timeliness and integrity. Learn more at the PharmSource website.