Catching a Wave: How Much Will CMOs Benefit From Biosimilars?
Regulatory developments in the United States, coupled with impending patent expiry, have paved the way for the introduction of biosimilars of increasing technical complexity. In the European Union, 20 first wave biosimilars, consisting of growth hormones and relatively simple recombinant proteins, have already been approved. Of those first wave biosimilars…
In-Licensed Drug Products Can Signal Outsourcing Opportunity
Of the more than 230 New Molecular Entities (NMEs) approved between 2003-2013, over one-third were in-licensed by the sponsor receiving the approval. A significant difference in manufacturing status emerged between…
CDMO and CRO Outlook: Robust Market Conditions Augur Growth, More M&A Activity Ahead
Emerging bio/pharmaceutical companies are benefitting from a surge in financing from venture capital, IPOs and secondary offerings. Funding raised in the first half of 2014 is double what was raised in the same period of 2013. R&D spending by global bio/pharma companies, including funds supporting emerging company partners, continues to…