Formulation Strategies for Follow-on Biologics

For this rapidly growing industry sector, little consensus or authoritative information is available yet regarding how and where biosimilar products will be produced. The future of their manufacturing is still up in the air. Much discussion among experts has focused on a dramatic up-tick in Contract Manufacturing Organizations (CMOs) involvement with process development projects and clinical-scale manufacturing for biosimilars. None have really set up commercial-scale projects (yet), however. Many such companies are publicly discussing large-scale partnerships for production in India and elsewhere in Asia. On the other hand, some biosimilars sponsors are establishing relationships with smaller biotech CMOs that have demonstrated expertise in efficiency or lower-cost business models.

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