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Case study-CMC challenges when a small biosimilar developer must rely on outsourcing for development and manufacturing

By: Patti Seymour
Presented at: Drug Information Association CMC Workshop. 24-26 Apr, 2017, New York, NY
This presentation is a case study that explores the CMC and manufacturing challenges facing a small biosimilar developer. Biosimilar market is expected to grow to ~$40 billion by 2020, which is attracting a large field of competitors. The first wave of biosimilars was dominated by global and large generic drug companies that accounted for more than 70% of biosimilar approvals. This next wave of growth and competition is focusing on monoclonal antibodies and fusion proteins, which are the next wave of biopharmaceutical products to lose patent protection. Dominance of the large companies reflects the high cost of developing biosimilars as well as the need for established infrastructure and experience to generate sales. Biosimilars may represent a large market opportunity, but CDMO-dependent developers may be at a disadvantage to established global bio/pharma companies.