Subscribe
  
IPQ Inside the global regulatory dialogue

MedImmune’s Agreement to Produce Merck’s Biosimilars Exemplifies Shifting Biotech Manufacturing Sands

Jul 31st, 2012

Please Log in to print the full article

MedImmune’s long-term, “trusted partner” agreement with Merck to produce Merck’s biosimilars exemplifies the shifting sands of biotech production capability and need and the different relationships that are being explored to handle that flux.

The 15-year contract signed last September calls for each firm using the other’s facilities in production areas where there is a capacity shortfall on the one side and an excess capacity on the other.

While Merck will be taking advantage of extra biotech manufacturing capacity at MedImmune in expanding into biosimilars, MedImmune will use excess microbial and fill/finish capacity at Merck for its needs in those areas.  MedImmune has already been producing monoclonal antibody-based clinical trial material for Merck under the agreement.

At an ISPE conference in Tampa, Florida, in February, MedImmune Capacity Utilization VP Darren Dasburg explained that a “trusted partner” relationship includes “the full benefits of reciprocity” and produces “significant savings in both directions.” Dasburg was VP of North American Engineering at GlaxoSmithKline prior to joining MedImmune in 2010.

In his presentation, the MedImmune VP detailed his firm’s agreement with Merck, including : ● why it was formed ● how it differs from other industry agreements ● implications for the manufacturing facilities involved, and ● how both firms are already benefiting from the arrangement.

[The story continues for subscribers beginning on page 2.  Nonsubscribers can purchase the story for $195 by contacting Wayne Rhodes ([email protected]).  For subscription/license information, click here.]

See related stories:

Safety Assurance in Focus at FDA Hearing on Biosimilar Guidance and Policy Refinement

Raft of Comments on FDA Biosimilar Draft Guidances Draw Attention to Protein Definition, Interchangeability and Naming

EMA’s Biosimilar Quality Guideline Redraft Sharpens Focus on Target Profiles and Lifecycle Changes of Reference Product

EMA’s Biotech CMC Focal Points Include Biosimilar Guideline Revisions and Joint Reviews with FDA

FDA’s Proposed Biosimilar User Fee Structure Explained to Congress by CDER’s Woodcock

FDA Release of Biosimilar Guidance Documents Opens Up New Chapter in Dialogue with Industry

FDA Releases Biosimilar Authorization Performance Goals for Comment as Efforts to Implement the New Act Continue

Make Interchangeability Decision After Biosimilar Approval, Amgen Urges FDA

Pages: 1 2

    ©2021 IPQ Publications