Reliable Supply Chain

Manufacturers of biologic medicines are responsible for monitoring all steps during product development and manufacturing to ensure that the medicine is pure, has the desired strength and is stable.¹ A reliable supply chain is key to this responsibility. Biosimilar supply chains should:

Ensure product authentication
Maintain strict warehouse security
Incorporate vigilant cargo security
Conduct market surveillance

Problems or interruptions to the manufacturing process of biologic medicines may not only affect quality and safety, but could also lead to delayed supplies and distribution of urgently needed medicines. Along with regulators, manufacturers have a responsibility to ensure strategies are in place to minimize incidences of drug shortages and possible supply disruption.^2-3

References

Desanvicente-Celis et al. Immunotherapy. 2012;4(12):1841-1857.
Felix, et al. Nat Biotechnol. 2014;32:128-129.
USFDA. Scientific considerations in demonstrating biosimilarity to a reference product. 2015.