The FDA clamps down on biologics manufacturing to promote biosimilars

By Dr Nicola Davies

With the high cost associated with branded biologics, the healthcare industry has seen a growing interest in biosimilars. However, significant barriers to accessing alternatives to biologics still exist, writes Dr Nicola Davies in her monthly FDA blog for The Pharma Letter.

One of these barriers is the high number of variables present in the development and manufacturing of branded biologics, which makes the process of copying the reference biologic challenging for biosimilar developers. If hurdles to the development and manufacturing of biosimilars persist, manufacturers might become dissuaded from pursuing biosimilar development.1