With its latest move, Merck
The drugmaker has signed up Parexel
Merck could have just hired experienced people to help it get through its manufacturing and regulatory process, but hiring Parexel will likely be cheaper in the long run. There's bound to be ebbs and flows in the process, which Parexel is better suited to handle since it can switch people between projects it has with other drugmakers.
Developing biosimilars -- copycats of protein-based drugs -- is a lot harder than it is for small-molecule drugs. Merck's move to develop biosimilars started back in 2008, but the company doesn't expect to launch a biosimilars product until the middle of the decade. The regulatory pathway for approving biosimilars in the U.S. hasn't even been established yet, so it's not exactly clear what drugmakers will need to do to gain approval.
It may take a large pharma with resources to burn like Merck or Pfizer
For now, Merck will have a while to wait for its biosimilars to progress through development. Patience may not be in style right now, but it could prove rewarding for shareholders eventually.
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